IMMULITE Troubleshooting Guide

®
IMMULITE
Troubleshooting Guide
Document number: 600414

January 2001 COMPANY CONFIDENTIAL
Table of Contents
CHAPTER 1. INTRODUCTION............................................................................... 1-1
CHAPTER 2. CHEMISTRY ..................................................................................... 2-1

2.1 Chemistry Handout...........................................................................................................2-1
2.2 One Adjustor Assay Seminar .........................................................................................2-10
2.3 Two-Point Adjustment ...................................................................................................2-19
2.4 The Effects of Altering the CAF and PMT ....................................................................2-22
2.5 Method Verification Data Review Guidelines ...............................................................2-29
2.6 Analytical Sensitivity .....................................................................................................2-33
2.7 Assay Information ..........................................................................................................2-36
CHAPTER 3. GENERAL TROUBLESHOOTING ................................................... 3-1

3.1 General Troubleshooting Tips..........................................................................................3-1
3.2 Assay Troubleshooting Worksheet ..................................................................................3-2
3.3 Are you running now?......................................................................................................3-3
3.4 Final Documentation in Clientele ....................................................................................3-4
3.5 CPS Troubleshooting .......................................................................................................3-5
3.6 Investigation of QC/Assay Issues.....................................................................................3-7
3.7 Non-Mechanical Troubleshooting Tips............................................................................3-8
3.8 Patterns in data .................................................................................................................3-9
3.9 Chemistry Troubleshooting Tips....................................................................................3-10

3.9.1 Control/Adjustor Problems ....................................................................................3-10
3.9.2 Water Issues ...........................................................................................................3-12
3.9.3 Testing for precision...............................................................................................3-13
3.9.4 B12 and folate ........................................................................................................3-14
3.9.5 Left over test units..................................................................................................3-14
IMMULITE Troubleshooting Guide 600414 i
For Internal Use Only

Table of Contents
3.10 Typical IMMULITE problems.......................................................................................3-15
3.11 Precision or Accuracy ....................................................................................................3-26

3.11.1 Possible causes of precision problems ...................................................................3-26
3.11.2 Possible causes of accuracy problems....................................................................3-28
3.12 Precision vs. Accuracy Grid...........................................................................................3-31
CHAPTER 4. ERROR MESSAGE TABLE.............................................................. 4-1

4.1 Error Message Table ........................................................................................................4-1
CHAPTER 5. MECHANICAL MODULES ............................................................... 5-1

System Overview and Associated Diagnostics.........................................................................5-1
5.2 Diagnostics Description Chart..........................................................................................5-2
5.3 Barcode Reader ..............................................................................................................5-15

5.3.1 Problems/Troubleshooting: ....................................................................................5-16
5.4 Load Platform.................................................................................................................5-19

5.5 Luminometer ..................................................................................................................5-22

5.6 Main Carousel ................................................................................................................5-26

5.7 Pipettor ...........................................................................................................................5-31

5.8 Reagent Carousel............................................................................................................5-38
5.9 Shuttle.............................................................................................................................5-44
5.10 Syringe Pumps................................................................................................................5-48

5.11 Temperatures ..................................................................................................................5-53

5.11.1 Temperature LEDs and how to decode them .........................................................5-56
ii 600414 IMMULITE Troubleshooting Guide

Table of Contents
5.12 Water and Substrate Pumps............................................................................................5-57

CHAPTER 6. HARDWARE ..................................................................................... 6-1

6.1 Laser Scanner Symbologies .............................................................................................6-1
6.2 Laser Scanner Programming ............................................................................................6-2
6.3 Power and Communication Tips ......................................................................................6-6
6.4 Printer Tips .......................................................................................................................6-8
6.5 Computer Input/Output Views .......................................................................................6-10
CHAPTER 7. SOFTWARE...................................................................................... 7-1

7.1 Ancillary Programs...........................................................................................................7-1
7.2 Program Descriptions and Database Repair.....................................................................7-9
7.3 Software Tips .................................................................................................................7-11

7.3.1 Significant Digit Options: ......................................................................................7-11
7.3.2 Deleting the database: ............................................................................................7-11
7.3.3 Date Time Conflict:................................................................................................7-12
7.3.4 Deleting Records: ...................................................................................................7-12
7.3.5 Editing Records: .....................................................................................................7-12
7.3.6 Printing Screens or Reports:...................................................................................7-13
7.3.7 Error 88: .................................................................................................................7-14
7.3.8 Control Entry:.........................................................................................................7-14
7.3.9 Entering Control Ranges for Qualitative Assays: ..................................................7-14
7.3.10 Searching for records: ............................................................................................7-14
7.3.11 Long Report Format: ..............................................................................................7-15
7.4 Software Scenarios/Case Studies: ..................................................................................7-16

7.4.1 Case Study 1:..........................................................................................................7-16
7.4.2 Case Study 2:..........................................................................................................7-16
7.4.3 Case Study 3:..........................................................................................................7-16
7.4.4 Case Study 4:..........................................................................................................7-17
IMMULITE Troubleshooting Guide 600414 iii

Table of Contents
CHAPTER 8. LIS (LABORATORY INFORMATION SYSTEMS)............................ 8-1

8.1 Upload of results ..............................................................................................................8-1
8.2 Broadcast Download ........................................................................................................8-2
8.3 Host Query .......................................................................................................................8-2
8.4 Configuring LIS ...............................................................................................................8-2
8.5 Possible Errors..................................................................................................................8-3
8.6 Addendum ........................................................................................................................8-3
CHAPTER 9. MISCELLANEOUS ........................................................................... 9-1

9.1 Bottle Volumes And Tests Per Bottle: .............................................................................9-1
9.2 Recommendations for Low Volume Use Customers .......................................................9-2
iv 600414 IMMULITE Troubleshooting Guide

Chapter 1. Introduction
Using the IMMULITE Troubleshooting Guide
The IMMULITE Troubleshooting Guide is a troubleshooting reference manual. It is not intended

to take the place of existing documents, such as the Operator’s Manual or the Service Manual,
but to be used in conjunction with them. The Troubleshooting Guide contains tips, hints,
procedures and details about IMMULITE troubleshooting that do not appear in other printed
materials. The Troubleshooting Guide can be a valuable source of information for technical
service, field service and product support personnel training.
This document is for internal use only. Do NOT distribute the IMMULITE
Troubleshooting Guide to customers.
Some of the information in the Troubleshooting Guide is presented in several locations in the
document. The information may be presented differently each time it appears. Troubleshooting
strategies vary according to situation and the troubleshooter’s preference and experience.
Presenting some information in several different ways helps to accommodate various approaches
to troubleshooting. It also can enable the troubleshooter to be more thorough when solving
problems that can be difficult to categorize or problems that “overlap” many categories.
The Troubleshooting Guide must be a dynamic document. Be sure to present any new or updated
information to IMMULITE Technical Services for inclusion in future updates. It is our intention
to ensure that the Troubleshooting Guide contains the most accurate, pertinent and current
information.
IMMULITE Troubleshooting Guide 600414 1-1

Introduction
1-2 600414 IMMULITE Troubleshooting Guide

Chapter 2. Chemistry
2.1 Chemistry Handout
The Immune Reaction
A. Sandwich Assay (ie hCG, TSH)
a) A polystyrene bead that is coated with an excess amount of antibody against a

molecule to be measured (i.e. hCG) is enclosed in a test unit.
b) The reagent wedge contains another antibody against a different area of the
molecule to be measured. Alkaline phosphatase is attached to the reagent antibody
(i.e. anti-hCG-alkaline phosphatase). The alkaline phosphatase is considered the
“label”.
c) Sample and reagent are added to the test unit. During the incubation the
molecule being measured (i.e. hCG) binds to the antibody coated bead, where it is
captured and held. The antibody from the reagent, which is labeled with the alkaline
phosphatase, will then bind to the captured substance (i.e. hCG) being held on the
bead.
d) Excess reagent and sample is removed. The test unit is spun at high at high
speed on its long axis ejecting any liquid out of the tube. Distilled water is injected
into test unit and the tube is spun again (repeated 4X). After the last spinning there
will be <2uL of liquid remaining.
e) Chemiluminescent Substrate is added. Chemiluminescent substrate is injected

into the test unit and incubated for 10 min. During incubation the alkaline
phosphatase label catalyses the substrate and photons of light are released.
f) Photon light output is measured. The test unit is moved in front of

Photomultiplier Tube (PMT) and the photon output is converted to count per second
(CPS).
g) Sandwich assays have a direct relationship between counts per second (CPS)
and dose (or result): The more molecule (i.e. hCG) present in the patient’s sample,
the more of it will bind to the bead. This will then capture more of the second,
labeled antibody from the reagent, resulting in more alkaline phosphatase being
bound to the bead. The more alkaline phosphatase on the bead, the more light
produced after substrate is added and the higher the counts for the sample. A high
CPS relates to a higher concentration of target molecules in the patient’s serum (i.e.
high hCG result). A low CPS result relates to a lower concentration of target
molecules in the patient’s serum (i.e. low hCG result).

Chemistry
B. Competitive Assay (ie TT4, E2)
a) The polystyrene bead that is coated with a limited amount of antibody against
the molecule being measured (i.e. TT4) is enclosed in a test unit.
b) The reagent wedge contains molecules analogous to the molecules to be

measured. The reagent analog is labeled with alkaline phosphatase (i.e. TT4-alkaline
phosphatase). There is no second antibody
c) Sample and reagent are added to the test unit. During incubation, the target
molecules in the patient’s sample (i.e. TT4) competes with the labeled molecule from
the reagent (i.e. TT4-alkaline phosphatase) for the limited number of antibody
binding sites on the bead.
d) Excess reagent and sample is removed. The test unit is spun at high speed on
it’s long axis ejecting any liquid from the tube. Distilled water is injected into the test
unit and it is spun again (repeated 4X). After the last wash there will be <2uL of
liquid remaining.
e) Chemiluminescent Substrate is added. Chemiluminescent substrate is injected

into the test unit and incubated for 10 mins. During incubation the alkaline
phosphatase label catalyses the substrate and photons of light are released.
f) Photons light output measured. The test unit is moved in front of the
Photomultiplier Tube (PMT) and photons output is converted to counts per second
(CPS).

Chemistry Handout
g) Competitive assays have an inverse relationship between CPS and dose

(result): The more target molecules (i.e. TT4) present in the patient’s sample, the
more of it will bind to the bead. As the patient’s target molecules take up antibody
binding sites on the bead, fewer sites remain available for the alkaline phosphatase-
labeled substance (i.e. TT4-alkaline phosphatase) from the reagent. This results in
less alkaline phosphatase label bound to the bead and therefore less light (lower CPS)
will be produced. Lower CPS relates to a higher concentration of the target molecule
in the patient’s serum (i.e. higher TT4 result). Higher CPS relates to lower
concentration of the target molecules in the patient’s serum (i.e. lower TT4 results).
Chemiluminescence
When substrate is added, the alkaline phosphatase bound to the bead will cleave a phosphate
group off of the substrate, causing it to emit photons of light, measured in counts per second, or
CPS.

Chemistry
Data Reduction
Dark counts:
Every cycle the PMT will take a 1 second dark count with the attenuator disk in the closed
position. This is a background count check. The dark counts should not exceed 300. The last
ten dark count reads are then averaged (running average).
Readings:
The attenuator disk turns to its attenuated position and a decision count is taken. If the counts
are below 10,240 the disk turns to its open, or unattenuated position. If the counts exceed 10,240
the disk remains in the attenuated position and 12, 1-second readings are taken by the PMT. The
average dark counts are subtracted from each reading. The highest and the lowest counts are
dropped and the remaining 10 are averaged.
CAF (Chemical Attenuation Factor)
When counts are taken with the attenuator filter in place, 99% of the light is blocked from the
PMT. This is useful for samples with very high counts, so they can still be read without blinding
the PMT. If samples are read with the filter in place, the CPS must be multiplied by that
instrument’s Chemical Attenuation Factor (CAF) to correct for the blockage of light.
PMT Factor
Each PMT is “calibrated” against a radioactive source of known value. A correction factor is
determined for each PMT so that they all produce the same output for this radioactive source.
This is done so that all PMT’s give close to the same counts for any given sample. The average
counts for a sample are multiplied by this PMT factor to standardize counts.
Summary of data reduction
1. A test unit moves in front of the PMT.

2. A dark count reading is taken and averaged with the prior 9 dark counts.
3. Attenuated decision count taken. Decision made to read sample with or without attenuator
disk.
4. The PMT takes twelve 1-second readings.
5. The average of the last 10 dark counts is then subtracted from each of the 12 readings.
6. The highest and lowest readings are dropped and the remaining 10 are averaged.
7. The mean CPS is multiplied by the PMT factor.

Chemistry Handout
8. If the test unit was read attenuated, the CPS are then multiplied by the CAF.
9. The CPS are then multiplied by the slope of adjustment and the intercept is added/subtracted.
10. The “adjusted” CPS are then read off the stored master curve to convert CPS to dose.
Adjustment Theory:
Refer to Section 8 of the Operator Manual-
A. A stored master curve has been developed in Euro DPC or DPC LA for each kit lot. The
curve is mathematically stored in the kit barcode parameters on the box flap, which is
wanded into the software by the operator. Adjusted CPS are read off this stored curve to
determine the actual dose of a sample.`
B. Every instrument will yield somewhat different counts (due to variations of each PMT).
Since the master curve was developed on one system and samples are run on another system,
different counts can be expected. Therefore, we can not use a curve generated on another
instrument to determine dose unless the two systems are equilibrated. We do this by
adjusting.
C. Initial Adjustments account for differences in PMT’s. Slope and intercept defines the
relationship between the customer’s instrument and the master curve instrument. These are
applied to CPS from the customer’s instrument to make them equivalent to the master curve
instrument CPS. At this point they can be read off the master curve.
D. A 10-15% variation is allowed between an initial slope and a readjustment slope. This
variation is due to loss of enzyme activity in the liquid reagent.
E. The sample CPS is multiplied by the adjustment slope and the intercept is either added or
subtracted. The counts are then read off the stored master curve that has been scanned into
the database and are then converted to a dose.
Interpreting Adjustment Results:
Refer to Section 8 of the Operator Manual-
A. IMMULITE software will reject an adjustment if:
a) CV’s between adjustor replicates exceeds cutoff (Competitive assays: 10% for low
and high adjustors. Sandwich assays: 15% for low adjustor, 10% for high adjustor).
b) negative slope (adjustors reversed or same one in both cups)
Note: If adjustment is rejected by instrument it will state which situation failed.
CV’s for adjustors can be found on the Test Parameters screen on the Kits menu.

Chemistry
B. Controls are primary criteria for customers to validate adjustment.
C. Slope. Different criteria for initial slopes vs. slopes of readjustment:
a) Initial slopes should fall within expected slope range (slope range=average of 10
initial slopes± 20%
b) Slopes of readjustment should be within 10-15% of previous slope.
D. Intercept – intercepts generally conform to the following guidelines, however situations

may occur where these guidelines are not applicable.
Calculated Intercept Cutoffs
Sandwich assay: A large intercept affects the dose calculation only at very low doses. The
intercept should be:
absolute value of the intercept ≤ low adjustor CPS of the master curve X 30%
|Intercept| 0DVWHU&XUYHORZDGMXVWRU&36[
Competitive Assay: The intercept should be:
absolute value of the intercept ≤ 2% of curve parameter 1 (P1). P1 is found on the Kit
Entry Screen
|Intercept| &XUYH3DUDPHWHU[
EXCEPTIONS: Estriol, Digoxin and, Phenobarbitol. For these 3 assays use Curve
Parameter 2 in the above calculation in-place of Curve Parameter 1.
If an adjustment doesn’t meet one or all of the criteria:
1. High or low slope, controls in range- indicative of compromised/degraded or contaminated

reagent. Readjust with fresh reagent.
2. High or low slope, controls out- indicative of improper adjustor handling.
3. Readjust with fresh adjustors.

Chemistry Handout
Control Results:
A. Customers must run controls according to their laboratory standard operating procedure
to check for precision and accuracy of the instrument and reagents. If controls are out of
range, based on the laboratory’s SOP’s, it could indicate an assay problem, a control material
problem, an operator error or, an instrument problem.
B. Customers must run controls to evaluate the validity of an adjustment.

Chemistry

Chemistry Handout

Chemistry
2.2 One Adjustor Assay Seminar
Slide 1 _____________________________
_____________________________
One Calibrator Assays _____________________________

_____________________________
T3 Uptake, Allergy, and Infectious
Disease Assays _____________________________
_____________________________
_____________________________
_____________________________
Slide 2 _____________________________
One Adjustor Assays
_____________________________
• There are two types of assays with one
adjustor _____________________________
– T3 Uptake
– Cut-off assays _____________________________
• Infectious Disease
• Allergy
_____________________________
_____________________________
_____________________________
_____________________________
Slide 3 _____________________________
One Adjustor Assays
_____________________________
• These assays all have a single calibration
point _____________________________
• When the “adjustor” is run, actually a
calibration curve is being run _____________________________
• Because it is a calibration curve, all
“adjustments” will be accepted _____________________________
• The only way to judge whether a calibration
curve is correct is the controls
_____________________________
_____________________________
_____________________________

One Adjustor Assay Seminar
Slide 4 _____________________________
T3 Uptake
_____________________________
• Both T3 and T4 in serum are mostly bound
to TBG. Less than 1% is free _____________________________
• The free form is in equilibrium with the
bound form and TBG. It is also in _____________________________
equilibrium with Albumin.
– T4 + TBG T4-TBG
_____________________________
• Only the free form of the hormone is
biologically active.
_____________________________
_____________________________
_____________________________
Slide 5 _____________________________
T3 Uptake
_____________________________
• In situations where TBG is increased, such
as pregnancy, total T4 will increase, but the _____________________________
free T4 concentration will stay constant.
• Before the existence of FT4, a correction to
total T4 values was required to account for
_____________________________
the T4 binding capacity of serum (TBG +
Albumin) _____________________________
• The correction factor is measured by the T3
Uptake assay _____________________________
_____________________________
_____________________________
Slide 6 _____________________________
T3 Uptake
_____________________________
• Uptake is an assay that measures the T3
(and therefore T4) binding capacity of _____________________________
serum
• Initially, T3 Uptake was measured by _____________________________
adding I125 T3 to serum and letting it
equilibrate with the binding proteins
• Free T3 was separated from bound T3 using
_____________________________
a resin which bound up the unbound T3
_____________________________
_____________________________
_____________________________

Chemistry
Slide 7 _____________________________
T3 Uptake
_____________________________
• If the binding capacity of serum is high,
such as in pregnancy, a small amount of T3 _____________________________
binds to the resin, therefore resin uptake is
low _____________________________
• If the the binding capacity of serum is low,
a large amount of radioactive T3 binds to
the resin and the resin uptake is high.
_____________________________
_____________________________
_____________________________
_____________________________
Slide 8 _____________________________
T3 Uptake
_____________________________
• For a normal pool of serum, approximately
30% of the added I125 T3 was not taken up
by serum and so was bound to resin. _____________________________
• This gives rise to the “normal “Uptake
value being 30% _____________________________
• High TBG concentrations result in low
uptake numbers, e.g. in pregnancy T3 _____________________________
Uptake is 20-25%. Low TBG gives high
uptake numbers.
_____________________________
_____________________________
_____________________________
Slide 9 _____________________________
T3 Uptake
_____________________________
• The total T4 is corrected by T3 Uptake to
account for different serum binding capacity
• This value is known as FTI (Free thyroxine
_____________________________
Index) or T7
– FTI or T7 = Total T4 x % T Uptake _____________________________
• An elevated T4 due to high TBG will be
brought back into the normal range by _____________________________
multiplying by the low uptake number and
vice versa.
_____________________________
_____________________________
_____________________________

Slide 10 _____________________________
T Uptake Assays
_____________________________
• The classical RIA T3 Uptake assays works
similarly to the resin assay _____________________________
• Radioactive T3 is added to serum
• The T3 not bound to protein is determined _____________________________
• The test uses a single calibrator.
_____________________________
_____________________________
_____________________________
_____________________________
Slide 11 _____________________________
CAC T3-Uptake Assay
_____________________________
_____________________________
_____________________________
_____________________________
Low TBG High TBG
High Uptake Low Uptake
High CPS Low CPS _____________________________
_____________________________
_____________________________
Slide 12 _____________________________
CAC T3- Uptake Assay
_____________________________
% Uptake ∝ CPS on Tube
_____________________________
% Uptake = CPS Patient x %Uptake of Calibrator
CPS Calibrator
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________

Chemistry
Slide 13 _____________________________
IMMULITE T3 Uptake
_____________________________
• Conjugates of T3 and T4 do not bind to
TBG so an indirect method is used _____________________________
• A large excess ‘cold’ T3 is added to serum
• The T3 binds to the empty sites on TBG _____________________________
saturating them and leaving some unbound
T3 left over _____________________________
• The unbound T3 competes with T3
conjugate to bind to the antibody coated
bead in a regular T3 assay
_____________________________
_____________________________
_____________________________
Slide 14 _____________________________
IMMULITE T3-Uptake Assay
_____________________________
_____________________________
_____________________________
_____________________________
Low TBG High TBG
High Uptake Low Uptake
Low CPS High CPS _____________________________
_____________________________
_____________________________
Slide 15 _____________________________
IMMULITE T3 Uptake Assay
_____________________________
%Uptake ∝ 1/ CPS of Bead _____________________________
% Uptake = Calibrator CPS x % Uptake of Calibrator _____________________________
Patient CPS
_____________________________
_____________________________
_____________________________
_____________________________

Slide 16 _____________________________
IMMULITE T3 Uptake
_____________________________
P2 on the barcode is the calibrator value
_____________________________
T3 Uptake = Calibrator CPS x P2
Patient CPS
_____________________________
Run controls to judge validity

_____________________________
Calibration cannot fail
_____________________________
_____________________________
_____________________________
Slide 17 _____________________________
One Adjustor Assays
_____________________________
• These assays all have a single calibration
point _____________________________
• When the “adjustor” is run, actually a
calibration curve is being run _____________________________
• Because it is a calibration curve, all
“adjustments” will be accepted _____________________________
• The only way to judge whether a calibration
curve is correct is the controls
_____________________________
_____________________________
_____________________________
Slide 18 _____________________________
Allergy and Infectious Disease
_____________________________
• These assays may be qualitative or
quantitative _____________________________
• Quantitative assays have full standard
curves and use normal 4 parameter logistics _____________________________
and 2 point adjustment
• The qualitative assays use a single
calibrator
_____________________________
_____________________________
_____________________________
_____________________________

Chemistry
Slide 19 _____________________________
Allergy and Infectious Disease
_____________________________
• The qualitative assays have three levels of
answer - Positive, Negative, Indeterminate _____________________________
• The answer is based on defining the cut-off
signal between positive and negative _____________________________
• The cut-off is determined empirically by
measuring a large number of negative sera _____________________________
_____________________________
_____________________________
_____________________________
Slide 20 _____________________________
Determination of Cut-Off
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________
_____________________________
Slide 21 _____________________________
Determination of Cut-off
_____________________________
• A negative serum is chosen as calibrator
• The ratio of the cut-off to the negative _____________________________
calibrator is determined.
• This is P1 _____________________________
• If no Indeterminate is required:
_____________________________
Cut-Off = CPS of Calibrator x P1
_____________________________
_____________________________
_____________________________

Slide 22 _____________________________
Sandwich Qualitative Assay
_____________________________
• All allergy and all but one of the infectious
disease qualitative assays are sandwich _____________________________
• IF Patient CPS > Cut-off POSITIVE _____________________________
• IF Patient CPS < Cut-off NEGATIVE
_____________________________
_____________________________
_____________________________
_____________________________
Slide 23 _____________________________
Competitive Qualitative Assay
_____________________________
• Only one is hepatitis anti core
_____________________________
• IF Patient CPS < Cut-off POSITIVE
• IF Patient CPS > Cut-off NEGATIVE _____________________________
_____________________________
_____________________________
_____________________________
_____________________________
Slide 24 _____________________________
Indeterminates
_____________________________
• For some qualitative assays an
indeterminate zone is defined. _____________________________
• The zone is defined as +/- a certain
percentage of the cut-off CPS _____________________________
• The percentage is found in P2
– e.g if the indeterminate is +/-10% of cut-off,
P2=0.1
_____________________________
_____________________________
_____________________________
_____________________________

Chemistry
Slide 25 _____________________________
Sandwich Indeterminates
_____________________________
• Cut-Off = CPS of Calibrator x P1
• Indeterminate = Cut-off (+/-) P2 x Cut-off _____________________________
• IF Patient CPS > Cut-off + P2xCut-off
POSITIVE _____________________________
• IF Patient CPS < Cut-off - P2x Cut-off,
NEGATIVE _____________________________
• Otherwise INDETERMINATE
_____________________________
_____________________________
_____________________________
Slide 26 _____________________________
Ratios
_____________________________
• Control values are now reported only as
positive or negative _____________________________
• Controls can be monitored by ratio- how
much higher or lower is the control than the _____________________________
cut-off - this will be in a future software
version
_____________________________
• RATIO = CPS / Cut-off _____________________________
_____________________________
_____________________________

Two-Point Adjustment
2.3 Two-Point Adjustment
The first time verbalizing the concept of a two-point adjustment can be quite daunting. Many of
your colleagues have collaborated in workshop sessions to share their best tips that can be used
when explaining two-point adjustment on the IMMULITE One and IMMULITE 2000. Here are
some general tips to consider, as well as some great analogies to use. Please read them over and
feel free to share some of your own ideas!
GENERAL TIPS:
1. Explain where to find specific numbers that you refer to. (i.e. Curve Parameter 1 found on
Kit Entry screen, master curve low adjustor CPS found on top of adjustment printout and on
Kit Entry screen). *
2. Start basic and build. *
3. Strive for a BASIC understanding for everyone. If you are dealing with a more sophisticated
individual you can go as far as you have to. However, in group sessions, you need to tailor
the discussion to the lowest level in the group…advanced participants can be addressed
individually.
4. Explain the source of the numbers on the Kit Entry screen and what numbers will change
upon adjustment and what numbers will stay the same. *
5. Refer to your own notes and visuals, and use your own style. You must be comfortable with
the material and the presentation of it to be effective *
6. Make reference to other materials, such as the Operator’s Manual, Training Manual, Tutorial,
and Technical Bulletins. Use as many resources as possible or as needed. *
7. When describing calculations, offer alternatives and examples. For instance refer to 20 per
cent as 20% and 0.20. Some people understand the concept better when presented one way or
another. *
8. BE CONFIDENT / BE REAL!!!! *
9. Highlight the benefits of the IMMULITE vs. their current method (i.e. stored curves vs.
running a standard curve each run for RIA). *
10. Explain the relationship of the signal between the lab instrument and the master curve
instrument…offer explanations for differences (i.e. PMT differences, shipping issues).*
11. Refer to y=mx+b when discussing slope and intercept. Some people may understand this
concept better this way. *
12. Discuss sandwich vs. competitive assays if appropriate (determine level of audience first). *

Chemistry
13. While lecturing, refer back to the kit components and barcode, as well as the Kit Entry
screen, to reinforce the theory. *
14. Also, during the lecture, refer back to the path of the tube and the CPS, or signal, as the final
product. Tie it all in. *
PRESENTATION TIPS
1. Use hand gestures…this was particularly effective when trying to illustrate low and high
slopes and how adjustor counts compare to the master curve.
2. Use visuals, charts, graphs etc.
3. A particularly effective use of visuals included the use of several graphs…the graphs began
on the left side of the white board. As a new graph was drawn, the common elements
between graphs was nicely illustrated by using the same color marker. This enhanced the
relationships between the graphs. At the end, an arrow was drawn from the last graph back to
the first graph, again to reinforce the relationship.
4. Write down ALL calculations on the board.
5. Don’t abbreviate.
6. Overlay graphs to demo the differences between the lab instrument and the master curve
instrument…this nicely illustrates the linear relationship and can introduce the “why” of
adjustment.
7. Check for understanding several ways, including direct questioning and observation of facial
expressions.
PHONE SPECIFIC TIPS
1. While you can’t observe facial expressions and mannerisms to check for understanding, you
need to pay particular attention to tone of voice, length of pauses etc. You may also have to
incorporate more direct questioning to truly understand their level of understanding. *
ANALOGIES
1. ADJUSTMENT: Compare two point adjustment to setting your home clock to an atomic
clock…standardizing the time. *
2. ADJUSTMENT: You’re trying to get two types of apples (NJ apples vs. LA apples) to taste
the same. *

Two-Point Adjustment
3. COMPETITIVE ASSAY: There are a limited number of seats available on a bus. Two
families get on the bus, one with 3 members, the other with 12 family members. A
competition for the seats is set up. The 12 member family will statistically get more seats
than the 3 member family. *
4. ADJUSTMENT: An adjustment can also be referred to as a “2 point match”. *
5. PMT DIFFERENCES: Refer to two different light bulbs and the differences in output. *
6. LOT TO LOT DIFFERENCES: Soup analogy…two different batches of soup can taste
different, even when following the same recipe and using the same ingredients. Also, you can
not compare two different types of soup (like chili and clam chowder) just like you can’t
compare two different assays (like TSH and E2). *
7. ADJUSTMENT: Grapefruit analogy…you send a grapefruit from LA to NJ and try to weigh
them with two different scales…you get two different weights. Need to standardize the
measurement. *
8. ADJUSTMENT: Foreign money conversion- Have to apply a conversion factor to make one
kind of currency equal to another kind. The factor changes on a regular basis so when
conditions change you need to convert again…this can also be used to tie in the need for
readjustment. *
The concept of a conversion factor, as described above in the foreign money analogy, is a
popular one. The point was made that just about everyone, regardless of background, is
familiar with the concept of a conversion factor. *
9. ADJUSTMENT: Use the tutorial! The analogy of measuring the dog with two different tape
measures is very effective.*
It was interesting that many of the general tips were discussed in all 4 sessions, which clearly
demonstrates their effectiveness (i.e. the use of visuals; don’t abbreviate; start simple, keep it
simple and build; be yourself; the use of analogies; reference to other resources). Keep these
“tried and true” methods in mind!
Since not everyone is actively involved in training as of yet, we tried not to focus on classroom
tips alone, but rather general tips applicable to any situation. Although some ideas would be
useful only in a face to face setting, any items followed by a red asterisk (*) would also be
effective on the phone.
*- Indicates a technique applicable to phone use.

Chemistry
2.4 The Effects of Altering the CAF and PMT
The Chemical Attenuation Factor (CAF) and PMT factors both play a role in standardizing the
CPS of a sample. The PMT factor is applied to “normalize” (or standardize) the output of all
PMT’s. The factor is determined for each individual PMT, based on its unique output response
to a known radioactive source, and is applied to the average counts of every sample run. The
CAF is applied when the neutral density filter is used to read a sample that exceeds
approximately a million CPS. In an effort to illustrate the practical effects of the PMT factor and
CAF, several experiments were performed in which the PMT factor and/or CAF were
manipulated, with data obtained under those conditions. The raw data was summarized for
easier viewing (see pgs. 2-22 to 2-25). A written analysis of the data, describing the conditions
of the run and subsequent effects on counts and dose, is offered below:
Correct CAF and PMT factor. Refer to pg. 2-22
Run 1 represents a TT4 adjustment, kit lot 189, with the correct PMT factor and CAF for training
instrument F812. Listed are the 4 sets of CPS for each level of adjustment and the averaged CPS
for each. Also listed are the slopes and intercept as well as the CPS and dose for 3 levels of
control. Please use this run as a reference, to compare results of the other runs to (notice that
both adjustors are running below the master curve counts, so comparing the other runs only to
master curve counts will not truly reflect the actual effect of the change).
Altered CAF or PMT factor. Refer to pg. 2-22 to 2-25
Runs 2 through 7 present various combinations of altering either the PMT and CAF. The
condition is listed on the top line for each run (i.e., Half PMT factor, correct CAF; Double PMT
factor, correct CAF etc.). The four replicates are again listed with the averages calculated, as
well as the slope and intercept of the adjustment and the dose and CPS for 3 levels of control.
The easiest way to see the effect is to compare the average CPS for each level of adjustor with
the average for that level in run 1. Also, compare the slopes. And finally, when looking at the
CPS for the controls, notice that they mirror the adjustor counts (cut in half, doubled etc.) yet the
doses are relatively unchanged…this very dramatically demonstrates the effect of slopes of
adjustment on results.
Runs 8 through 10 were run on TSH, lot 224, to better illustrate the role of the CAF. Remember
that the CAF only comes into play when the attenuation filter is used, which occurs when counts
are greater than 1 million. In the TT4 examples, both levels of adjustor and the controls report
out CPS greater than 1 million, so a change in CAF would effect all of them. However, with
TSH, the low adjustor and the diluent are present, counts are less than 1 million.
Run 8 is the original TSH adjustment, done with the correct PMT factor and CAF. Adjustor
replicates and means are again listed, as well as slope, intercept, control CPS and control doses.

The Effects of Altering the CAF and PMT
Run 9 has the correct PMT factor but half the CAF. In comparing the average CPS notice that
the low adjustor CPS are relatively close to Run 8. However, the high adjustor CPS (above 1
million) are essentially cut in half. Notice the effect on the slope (almost doubled what would be
expected with half the counts). Looking at the controls, the CPS for Con 4 are below 1 million
and therefore would not be effected by the CAF change. However, look at the dose…the 2.68
slope really bumps that dose up (remember that the counts are similar, certainly not cut in half,
so multiplying by a higher slope will increase the dose above what is expected- kind of a falsely
elevated result). But, if you look at the counts for levels 5 and 6 you’ll notice they are above 1
million…the CAF now comes into play. Comparing them to the counts from Run 8 you’ll see
that they are roughly half, because the CAF is half. However, the doses are not that
different…even though the counts are half, the slope of 2.68 brings the dose back up (the two
essentially cancel each other out…half the counts but double the slope). Notice that the TSH
zeros are relatively unchanged (below 1 million so the CAF has no effect).
In run 10 the CAF is correct but the PMT factor was cut in half. Recall that the PMT factor is
applied to ALL counts. Keeping this in mind, observe that the low and high adjustor CPS are
half that of Run 8, which is exactly what is expected. Because of this the slope is higher (almost
doubled at 2.47). The control counts are half because of the PMT (as expected), yet the doses
are quite close to Run 8 (half the counts, but they were multiplied by a higher slope of 2.47,
which again cancels each other out). And finally, as expected the TSH zero counts are half that
of Run 8 (PMT factor cut in half).

Chemistry
The Effect of altering the CAF and PMT factor:
Training Instrument F812 Correct PMT= 0.73 Correct CAF= 129
Run 1 Correct PMT factor (0.73) Correct CAF (129) TT4 kit lot 189
Low adjustor CPS (master= 37190350) High adjustor CPS (master= 13607580)
26206100 10322068
27891930 9472090
27722048 9732752
29230274 9710434
Average CPS = 27762588 9809336
Slope = 1.3 Intercept= 722379.6
Controls:
CON 4 CPS= 28119916 Dose= 3.2
CON 5 CPS= 14846278 Dose= 8.7
CON 6 CPS= 11132024 Dose= 12.4
Summary: Correct PMT factor and CAF (use as baseline for comparison for runs 2-7,TT4 kit)
Run 2 Half PMT factor (0.37) Correct CAF (129) TT4 kit lot 189
14988032 5420744
14270602 5046732
14796873 5164434
14378901 4945115
Average CPS = 14608602 5144256.25
Controls:
CON 4 CPS= 16184575 Dose= 2.7
CON 5 CPS= 7435379 Dose= 9.3
CON 6 CPS= 5484273 Dose= 13.4
Summary: 1/2 PMT factor, Correct CAF- all CPS about 1/2, slope about 2X, control doses unchanged

Run 3 Double PMT factor (1.46) Correct CAF (129) TT4 kit lot 189
55338624 19795476
54538180 20787840
58051476 20002086
55758812 19305980
Average CPS = 55921773 19972845.5
Slope = .66 Intercept= 505245.5
Controls:
CON 4 CPS= 63140422 Dose= 2.6
CON 5 CPS= 30660999 Dose= 8.5
Summary: 2X PMT, correct CAF- all CPS about 2X, slope about 1/2, control doses unchanged
Run 4 Correct PMT factor (0.73) Half CAF (65) TT4 kit lot 189
13938675 4912072
13570321 4665759
14488051 5011005
14578206 5097601
Average CPS = 14143813.25 4921609.25
Slope = 2.55 Intercept= 1022180
Controls:
CON 4 CPS= 15475486 Dose= 2.8
CON 5 CPS= 7508346 Dose= 8.7
CON 6 CPS= 5444271 Dose= 12.8
Summary: Correct PMT factor, 1/2 CAF- all CPS about 1/2, slope about 2X , control doses unchanged

Chemistry
Run 5 Correct PMT (0.73) Double CAF (258) TT4 kit lot 189
53045964 19302214
53568040 19696222
53536400 20187036
54003296 18977892
Average CPS = 53538425 19540841
Controls:
CON 4 CPS= 61757253 Dose= 2.4
CON 5 CPS= 29770528 Dose= 8.4
CON 6 CPS= 20287609 Dose= 13.7
Summary: Correct PMT factor, 2X CAF- all CPS about 2X, slope about 1/2, control doses unchanged
Run 6 Half PMT factor (0.37) Half CAF (65) TT4 kit lot 189
6929094 2447040
7167021 2529291
6588426 2247617
6763943 2546222
Average CPS = 6862121 2442542.5
Controls:
CON 4 CPS= 7170916 Dose= 3.0
CON 5 CPS= 3921834 Dose= 8.0
CON 6 CPS= 2409040 Dose= 14.6
Summary: ½ PMT factor, ½ CAF- all CPS about ¼, slope 4X, control doses unchanged

Run 7 Double PMT factor (1.46) Double CAF (258) TT4 kit lot 189
94007656 35878772
108714368 38096288
108193048 38266544
103095056 38285756
Average CPS = 103502532 37631840
Controls:
CON 4 CPS= 121278533 Dose= 2.4
CON 5 CPS= 58032829 Dose=8.3
CON 6 CPS= 39063224 Dose= 13.7
Summary: 2X PMT factor, 2X CAF- all CPS about 4X, slope about 1/4, control doses unchanged
Run 8 Correct PMT factor (0.73) Correct CAF (129) TSH kit lot 224
28306 4571012
25249 4521196
27597 4537205
26508 4597380
Average CPS = 26915 4556698.25
Slope = 1.4 Intercept= -12193.26
Controls:
CON 4 CPS= 479271 Dose=0.414
CON 5 CPS= 3849764 Dose= 3.63
CON 6 CPS= 17690117 Dose= 18.8
TSH Zeros CPS:

24529 26136 27395 24148 69903
Average CPS (excluding 69903)=25552
Summary: Correct PMT factor and CAF for system- use as baseline for comparison for runs 9-10, TSH kit

Chemistry
Run 9 Correct PMT (0.73) Half CAF (65) TSH kit lot 224
26615 2343508
27704 2352381
26732 2452359
29018 2437127
Average CPS = 27517.25 2396343.75
Controls:
CON 4 CPS= 562695 Dose=0.944
CON 5 CPS=2239118 Dose= 4.03
CON 6 CPS= 10082271 Dose= 20.8
TSH Zeros CPS:
25386 27568 25292 26137 27070
Average CPS = 26291
Summary: Correct PMT, 1/2 CAF- low adjustor CPS unchanged, high adjustor CPS about 1/2, slope about 2X, con4
counts about same, but dose about 2X, con 5 and 6 counts about 1/2, dose about same, zeros unchanged.
Run 10 Half PMT (0.37) Correct CAF (129) TSH kit lot 224
14423 2634983
14304 2500098
12768 2637894
14380 2569831
Average CPS = 13968.75 2585701.5
Controls:
CON 4 CPS=272626 Dose= 0.417
CON 5 CPS= 2362110 Dose=3.93
CON 6 CPS= 10776145 Dose= 20.4
TSH Zeros CPS:

13214 13210 13095 12628 13854
Average CPS =13200
Summary: 1/2 PMT, Correct CAF-all CPS about 1/2 (adjustor and control ), slope about 2Xcontrol doses unchanged,
zeros about 1/2.

Method Verification Data Review Guidelines
2.5 Method Verification Data Review Guidelines
Purpose: To outline review process for data sent to “TSR Method Verification Data” by TSRs.
Introduction:
The data sent in for review by TSRs potentially serves two purposes. First it is always a
documentation of the performance of the assay/instrument at the time of the study and secondly,
the method comparison data may be useful for inclusion in the Method Comparison database.
This database is a library of method comparisons of IMMULITE assays compared to various
other immunoassay systems.
The data is currently contained in an Excel spreadsheet that may include the following
worksheets:
1. intra assay precision – precision study based on data generated in a single run
2. inter assay precision – precision study based on data generated over several days
3. calibration – study using calibration verifiers to confirm accuracy / reportable range
4. sensitivity – study to calculate the analytical sensitivity for an assay
5. dilute – study to evaluate dilutional linearity of an assay
6. reference range – study to evaluate selected patient results to estimate a reference

range
7. method comparison – study to compare results obtained by another method to

IMMULITE assay
Not all of these worksheets will be present in all data files sent in. They do not all need to be
present. For evaluation purposes a precision study should be included with verification of the
reportable range and usually method comparison data.
Definitions:
Reportable Range: term used by CLIA (Clinical Laboratory Improvement Act, [USA]) to
describe the range of concentration over which the assay gives accurate, precise results without
dilution. DPC product documentation refers to this range as the Calibration Range
Reference Range: the range of values seen in a population of healthy individuals. This range
used to be referred to as the “Normal range”, though use of that term has fallen out of favor as
too ambiguous. Generally the reference range is defined as the range covered by the central 95%
of results obtained from a reference populations of healthy individuals. This means that, by
definition, 5% of healthy people will have results outside of the range.

Chemistry
Analytical Sensitivity: the theoretical lowest concentration that an assay can detect. More
properly called the Detection Limit. Generally established by assaying 20 replicates of a true
zero concentration sample and then calculating the mean and SD of the signal (CPS). The
analytical sensitivity is defined as the dose equivalent to 2 SD away from the mean signal for a
zero sample. This indicator of assay performance has little practical usefulness as the precision
of the assay typically become so poor at concentrations greater than the analytical sensitivity that
results are not useful. This is why the lower limit of the calibration range is almost always at a
greater concentration than the analytical sensitivity.
Protocol:
The review of the data should be principally directed at whether or not the data supports product
claims as well as a review for any potential instrument issues. Is the data consistent with our
performance claims in the package insert? Is the data consistent with current in-house
performance of the assay? Look at the data and answer these two questions.
Once the data have been reviewed, write a brief summary and forward it to the “TSR Method
Validation Data” e-mail list. If the data is consistent with claims a simple statement of “meets
claims” for each study done is adequate for the summary. If the data is not consistent, then, in
the summary, state what claims are not met. Please be specific. Don’t just say, “Precision does
not meet PI claims”. See below for specific information for each study: Include any
conversations that were had with assay specialists regarding assay performance.
Precision study: include a statement of the mean and SD for each material tested. Then state
how it compares to the product claims. (“observed mean was about 4 SD above expected
mean”).
Calibration study: include a statement of which calibration verifier concentration(s) did not meet
claim for recovery and by how much they were off. Also note whether the problem appeared to
be bias (good reproducibility, but at the wrong concentration) or scatter in the data.
Sensitivity study: include a statement of the calculated sensitivity at 2 SD and 3 SD and what the
product claim is.
Dilution study: include statement of which dilutions did not recover and provide values for
expected value (what we should have gotten) and the actual results.
Reference range study: if a substantial number of values fell out side of the expected reference
range, include a statement of the number of values that were outside the range and what was the
result most outside the range.

Method Verification Data Review Guidelines
Method Comparison study:
Typically method comparison data shows results obtained with both the IMMULITE and another
method. The data is usually listed and also presented graphically in two formats. One is a
scatter plot that compares the results directly and usually includes a calculated regression line
along with the slope and intercept that describe the line. The other plot is a bias plot that
compares the % difference between the two methods to the result obtained by the comparative
method. Most all conclusions can be drawn by looking at the graphs.
Note: if there are less than 20 data pairs, the method comparison study is not usually of much
value so interpret very small data sets with much caution. Results that are reported as “greater
than” or “less than” should not be included. Results from diluted samples should not be
included.
Scatter plot:
When reviewing the scatter plot there are two basic aspects of the relationship between the
IMMULITE results and the comparative method that need to be checked, correlation and bias.
Correlation ONLY describes how scattered the data is compared to the calculated regression
line. You can see how scattered the data is on the plot and can also use the calculated correlation
coefficient or “R”. If there is a lot of scatter in the data, or the “R” is less than 0.9, mention this
in the summary.
Bias describes the numerical difference between the results (i.e. the IMMULITE result is twice
the comparative method result). Bias is best characterized by the regression slope and intercept.
Always include the slope and intercept in your summary. Also check the PI or our current
method comparison database to see how the bias in this study compares to what we may have
seen before comparing to the same method. If this study shows a different bias, mention that in
the summary.
Also when looking at the scatter plot, be careful to note whether the regression line seems overly
influenced by a few data points. Often one or more data points at a high concentration will
strongly influence the regression line. This is usually noticeable because the line does not go
through the rest of the data as well as it could. The regression line should go through the middle
of ALL the data. If it looks as though a few data points are influencing the line, try temporarily
removing them from the scatter plot and the calculation of slope and intercept. If the line seems
to fit the rest of the data better after removing these points, mention this in the summary and
make note of the slope and intercept from this trimmed data as well. This is often the result of
having very few data points at high concentration.
Bias plot:
The bias plot indicates how the difference between the two methods changes with concentration.
Ideally the data points should be scattered closely around the horizontal axis. This plot can
reinforce what is seen on the scatter plot and is another way to detect data points that may not be
consistent with the rest.

Chemistry
Once the method comparison data has been reviewed, it may be included in the method
comparison database. The decision to include the data will be made by the reviewers on the
“TSR Method Validation Data” e-mail list. The decision will be based on the number of points
in the study, the quality of the results, and the need for another comparison study involving the
comparative method.

Analytical Sensitivity
2.6 Analytical Sensitivity
Analytical Sensitivity, Functional Sensitivity and Calibration Range
There are a number of terms and concepts that relate to defining the lowest concentration an
IMMULITE assay can report and these can often create confusion for the customer. These terms
and concepts are often misunderstood. Listed below is a definition for some of these terms.
Analytical Sensitivity:
This is what is published in the package inserts as Sensitivity. The formal definition is: “the
lowest concentration that can be distinguished from background noise.” This value is
determined by assaying replicates (usually 20) of a sample that is known to have zero
concentration of the analyte. Then the CPS from these replicates are used to calculate a mean
and SD. The analytical sensitivity is set as the dose equivalent to the mean plus 2 SD for
immunometric assays and the mean minus 2 SD for competitive assays. This experiment is often
replicated for customers during validation studies, though there is NO regulatory requirement to
do so.
In the clinical lab, analytical sensitivity has little practical value. The basic reason is that for
almost all assays (especially competitive) the imprecision of the assay increases so rapidly at low
concentrations that, well before the analytical sensitivity is reached, the SD is so large that
results are virtually irreproducible and of little clinical value. This phenomenon can best be seen
by looking at a precision profile, which is a graphical representation of how the precision of an
assay changes with concentration. A number of IMMULITE package inserts include precision
profiles.
The analytical sensitivity does NOT represent the realistic lower limit of effective performance
for assays, though customers often think it does and the package insert often adds to this
confusion. This is why the lower limit of the calibration or reportable range of the assay, as set
in the software, is almost NEVER equal to the analytical sensitivity.
This limitation of the analytical sensitivity is not new, it applies to RIA, IMMULITE, and all
methods by all manufacturer’s. How it is handled is what varies. The manufacturer could have
the assays report down to this limit and as long as users didn’t run replicates, they would
probably never notice the poor precision. However, DPC chooses not to do this and instead
limits the calibration range to what is the truly useful range of the assay. The confusion about,
and the limited usefulness of, analytical sensitivity for describing effective assay performance,
led to the development of another concept. Functional sensitivity.

Chemistry
Functional Sensitivity:
About a decade ago, in reaction to the limited usefulness of analytical sensitivity, a group of
researchers evaluating TSH assays invented the concept of functional sensitivity. The formal
definition is: “the lowest concentration at which an assay can report clinically useful results.”
The group arbitrarily defined “clinically useful results” as good accuracy with a day to day CV
of not more than 20%. They felt that a CV of 20% was the most imprecision that could be
tolerated for the results to be clinically useful. This definition strictly applies only to TSH, but
the 20% guideline and the concept has been widely applied to virtually all other immunoassays.
This has happened because the concept makes sense and provides the user with a real world
meaningful, objective indication of the useable lower limit of an assay.
This same philosophy is applied to setting the lower limit of the calibration, or reportable, range
for IMMULITE assays. The 20% CV limit is NOT strictly applied, but the approach is the same.
When developing the assay, we look at the performance and decide at what concentration the
limit of clinical usefulness is reached. This is what determines the lower limit put in the software
and it is almost NEVER equal to the analytical sensitivity. In fact, for competitive assays
especially, there is usually a substantial difference between the analytical sensitivity and the
lower limit in the software.
Calibration Range (or the reporting limits set in the software):
The calibration range is defined as the range of concentration that DPC has decided is the
effective range of the assay and will support. This functionally coincides with the CLIA concept
of Reportable Range, which is the range of concentration over which assay performance is
documented as acceptable. There is not a fixed set of criteria that determine the calibration
range. The lower bound of the calibration range is NOT necessarily the functional sensitivity as
defined above, but the concept is the same. During assay development, it is decided what is the
range of concentration over which the assay will work and that can be supported. This range is
then put into the software. There are always competing demands in setting this range. For
marketing purposes the range should be as broad as possible. This is always balanced by the
realities of the chemistry.

Analytical Sensitivity
Some observations:
There is NO requirement that the calibration range of an assay encompass reference ranges
published in the literature or even ranges we publish. It gets a little tricky with our own ranges.
When IMMULITE first came out many of the reference ranges were established by performing
method comparison experiments with IMMULITE and Coat-a-Count (CAC). The slope and
intercept from these comparisons were then used to adjust the CAC reference range to adapt it to
IMMULITE use. This made good use of the well established and documented CAC reference
ranges and is a perfectly reasonable way to establish a reference range (see NCCLS guidelines
for establishing reference ranges). However, for a number of the assays, the CAC assay has
better performance at the low end and was able to measure lower concentrations. As a
consequence, the adjusted reference range may have a lower bound that is below the lower
reporting limit of the IMMULITE assay. For a number of assays (especially fertility) we have
been developing IMMULITE specific ranges by doing large multi-center studies and the PI
ranges are being revised as the data becomes available.
Some doctors get very alarmed by seeing a result of “less than 20” when the reference range may
be reported as 5 – 30. If the upper limit of the reference range is 30 and all relevant pathology
causes an elevated result (i.e. greater than 30), then a result of “less than 20” is within the
reference range, and, as such, is “normal” and unambiguous. Over the years there have been
many chemistry methods that don’t have lower reporting limits as low as we all would like. This
is not just an immunoassay issue and for sure not just a DPC issue. It is our role in Technical
Services to not lose sight of that and to help the customer not lose sight of that. Remember that
not too long ago the reference range for TSH was “undetectable to 10” as ALL TSH assays were
unable to measure the lower bound of normal.

Chemistry
2.7 Assay Information
Allergy
Assay Test Code Indications for use

AlaTOP® Allergy Screen TOP AlaTOP is a mixture of 12 inhalant allergens in one
assay. Allergens included are: Dermatophagoides
pteryonssinus, cat epithelium, Timothy grass,
Penicillium notatum, Birch, Japanese Cedar,
Parietaria officinalis, dog dander, Bermuda grass,
Alernaria tenuis, common ragweed, English
Plantain. Results will be either positive or
negative. The specific allergic allergen is not
identified.
Allergy Food Panel FP5E FP5 A qualitative (giving a positive or negative answer)
test used as an aid in the clinical diagnosis for
common food allergies (egg white, milk, codfish,
wheat, peanut and soybean).
Cat-Specific IgE CAT Used as an aid in the clinical diagnosis for an

allergy to cats
Dog-Specific IgE DOG Used as an aid in the clinical diagnosis for an

allergy to dogs
Latex-Specific IgE LAX Used as an aid in the clinical diagnosis for an

allergy to latex
Mite-Specific IgE MIT Used as an aid in the clinical diagnosis for an

allergy to mites (minute, extremely small, animals
which are parasitic to man and animals)
Total IgE TIE Used for the quantitative (giving an exact amount)
measurement of total immunoglobulin type E (IgE)
in serum. Total IgE level increases with the
number of allergies which a person has and with
the amount of exposure to relevant allergens

Assay Information
Anemia

Erythropoietin EPO Used as an aid in the diagnosis of anemia (a
reduction in the number of red cells or hemoglobin
(a hormone secreted by the in the blood) and polycythemia (an increase in the
kidney which acts on the production of red blood cells)
bone marrow to stimulate
red blood cell production)
Ferritin FER Used as an aid in the clinical diagnosis of iron

deficiency anemia and overload or in
(main storage molecule for discriminating iron deficiency anemia due to other
iron) causes
Folic Acid FOL A vitamin essential for red blood cell production.
Lack of folic acid can result in megaloblastic
anemia
Vitamin B12 VB Used as an aid in clinical diagnosis and treatment

of anemia. Essential for the production of red
blood cells.
Bone Metabolism

Intact Parathyroid Hormone PTH Used as an aid in the differential diagnosis of
hypercalcemia (an excess of calcium in the blood)
and hypocalcemia (a reduction of the blood calcium
below normal)
Pyrilinks®-D DPD A test on urine which measures the excretion of

Pyrilinks-D which is an indicator of bone
resorption (bone degradation)

Chemistry
Cardiac Markers

Creatine Kinase CMB An enzyme secreted in the blood and is used as an
aid in patient management and the assessment of
(CK-MB) prognosis of myocardial infarction (AMI)/heart
attack
Myoglobin MYO A protein secreted into the blood stream during a

heart attack. This test can be used as an aid in the
diagnosis of acute myocardial infarction
(AMI)/heart attack
Troponin , TPI A protein secreted into the blood stream during a

(AMI)/heart attack
Diabetes

Urinary Albumin ALB The assay is run on a urine sample for the detection
of microalbuminaria which characterized by
increased urinary excretion of albumin in both
insulin and non-insulin dependent diabetes. Used
in accessing the risk of kidney problems in patients
with diabetes.
C-Peptide CPE Used as an aid in the diagnosis of patients with

abnormal insulin secretion. Low levels are
expected where insulin secretion is diminished.
Elevated levels may result from insulin producing
tumors.
Insulin INS Used for the quantitative measurement of insulin in

serum or heparinized plasma, for the management
of diabetes. Helps to differentiate between
diabetics that require insulin and those who can be
controlled by diet alone. Insulin is produced by the
pancreas and is the principal regulator for the
storage and production of carbohydrates.

Assay Information
Drugs of Abuse

Cannabinoids THCA Used to detect the use of marijuana
Cocaine Metabolite COM Used to detect the use of cocaine
Opiates Screen OPI Used as a screen for opiates and metabolites in

urine, such as morphine, codeine and heroin
Infectious Disease (TORCH)

Cytomegalovirus IgG CMV Used as an aid in the determination of CMV
infection. CMV is a member of the herpevirus
family spread through sexual contact or infected
body fluids
Herpes I & II IgG HER Used as an aid in the determination of HSV I

(ocular and oral) & II (genital) infection
Herpes Simplex Virus
(HSV)
Rubella IgG (Quantitative) RUQ Used to determine if a patient has had German
Measles. Patients previously infected with German
measles and vaccinated individuals will have
detectable IgG antibody levels
Toxoplasma IgG TXQ Toxoplasmosis is an organism that is most

frequently transmitted through ingestion of
(Quantitative) inadequately cooked meat. Domestic cats have
been implicated in the transmission of the disease.
Patients previously infected with Toxoplasmosis
will have detectable IgG levels.
All the above organisms can cause severe congenital infections when they occur in utero (within
the uterus) or during birth.

Chemistry
Reproductive Endocrinology

Dehydroepiandrosterone DHS An adrenal steroid that is important to
Sulfate (DHEA-SO4) investigations of abnormal hair growth (hirsutism)
or balding in women (alopecia). Excess DHEA in
women and children causes masculinization
Estradiol E2 Used as an aid in the diagnosis and treatment of

ovarian function. Can be used in evaluation of
infertility and menstrual irregularities
Unconjugated Estriol FE3 Used as an aid in monitoring fetal maturity and

well being in the context of high-risk and poorly
dated pregnancies
Follicle Stimulating FSH Used as an aid in the diagnosis and treatment of

Hormone pituitary and gonadal (ovaries and testicles)
disorders
Human Chorionic HCG Used for the quantitative measurement of human

Gonadotropin chorionic gonadatropin (HCG) in serum and for
strictly qualitative determinations in urine, as an aid
in the detection of pregnancy
Lutenizing Hormone LH LH is used to define hypogonadism and infertility.

It is also used in the management of peri (before)-
and postmenopausal status.
Progesterone PGN A hormone which plays an important role in the

preparation for and maintenance of pregnancy. It is
used to confirm the occurrence of ovulation and to
assess corpus luteum (a glandular mass in the
ovary) function.
Prolactin PRL Its essential role is the stimulation of the secretion

of milk. It is also used in the work-up for infertility
and menstrual problems.
Sex Hormone Binding SHBG SHBG is higher in women than in men. SHBG is
Globulin elevated in anorexia nervosa, hyperthyroidism, and
hypogonadism. SHBG is suppressed in obesity,
hypothyroidism, hirsutism, and ploycystic disease.

Assay Information

Total Testosterone TTE Testosterone is the major hormone responsible for
sexual differentiation and male secondary
characteristics. In males, testosterone measurement
is useful in diagnosis of hypogonadism and
hypopituitarism. In females, it is used to evaluate
polycystic ovaries, ovarian tumors and virilization
(development of male secondary characteristics)
Therapeutic Drug Monitoring

Digitoxin DGT Used in the therapeutic administration of this drug
which is used in the treatment of congestive heart
failure and certain arrhythmia’s (Abnormal rhythms
of the heartbeat)
Digoxin DGX Used as an aid in monitoring the therapeutic

administration of this drug which is used in the
treatment of congestive heart failure and certain
arrhythmias
Theophylline THE Theophylline (a prescription drug) is used as a

bronchodilator in the prevention and treatment of
asthma.
Thyroid Function

Free T3 FT3 T3 measurement is indicated in patients with
decreased TSH and normal Free Total T4 levels.
(A hormone produced by Useful in evaluation of hyperthyroid (decreased
the thyroid glands) thyroid function) states.
Total T3 T3 T3 measurement is indicated in patients with

decreased TSH (thyroid stimulating hormone) and
(A hormone produced by normal Free or Total T4 levels. Useful in
the thyroid glands) evaluation of hyperthyroid (increased thyroid
function) states.

Chemistry

Free T4(Thyroxine) FT4 Used as a second line test after TSH to determine
thyroid status. Low TSH and increased Free T4
(A hormone produced by characterize hyperthyroidism. Hypothryroidism is
the thyroid glands) characterized by high TSH and decreased Free T4.
Total T4 (Thyroxine) T4 The principal thyroid hormone. Used as an aid in

the clinical assessment of thyroid status
(A hormone produced by
the thyroid glands)
Thyroxine Binding TBG TBG is more of an “esoteric (obscure) assay” that

Globulin may be used to confirm that extremes in T4
concentrations in an otherwise normal patient are in
fact the result of extremes in TBG concentrations
(genetic, drugs, pregnancy, etc)
Thyroglobulin TG Used in the management, not diagnosing thyroid

cancer.
Anti-thyroglobulin ATG Used as an aid in clinical diagnosis of thyroid

antibodies (Anti-TG Ab) diseases. High levels are found in patients with
Graves disease and Hashimoto's thyroiditis (major
cause of hypothyroidism)
Anti-thyroid peroxidase ATA Used as an aid in clinical diagnosis of thyroid

antibodies diseases. High levels are found in patients with
Graves disease and Hashimoto’s thyroiditis
(Anti-TPO Ab)
Thyroid Uptake TU Used as an aid in the clinical assessment of thyroid

status. It provides an index of circulating thyroid
hormone carrier protein levels.
Rapid TSH RTH TSH stimulates the thyroid gland to release free T4
and T3. Used to determine thyroid status, high
(thyroid stimulating TSH in hypothyroidism, low TSH in
hormone) hyperthyroidism. Also used in monitoring thyroid
replacement medication.
faster and less expensive
than third generation TSH

Assay Information

Third Generation TSH TSH TSH stimulates the thyroid gland to release free T4
and T3. Used to determine thyroid status, high
(thyroid stimulating TSH in hypothyroidism, low TSH in
hormone) hyperthyroidism. Also used in monitoring thyroid
replacement medication.
10X more sensitive than
rapid TSH and allows for
more refined evaluation of
thyroid status
Tumor Markers
A tumor marker is a protein that can be associated with a particular form of cancer.

Alpha-fetoprotein AF Used as an aid in the management of patients with
testicular cancer. Also used in conjunction with
ultrasonography to aid in the detection of fetal
neural tube defects
Carcinoembryonic Antigen CEA Used as an aid in the management of cancer

patients and in the assessment of prognosis. CEA
is primarily used to help diagnose colorectal
carcinoma. CEA values 5X normal are usually
indicative of malignancy
OM-MA (CA125) OV Used as an aid in monitoring the response to

therapy for patients with epithelian ovarian cancer
and in detecting residual ovarian cancer in patients
who have undergone first line therapy.
Prostatic Acid Phosphatase PAP Used as an aid in patient management of elevated

levels in patients with advanced prostate cancer.
Useful in monitoring remission or relapse of a
prostatic malignancy and in assessing the
effectiveness of treatment
Third Generation PSA SPS Because of it’s greater sensitivity, it is used for
monitoring residual or recurrent disease post radical
Prostate Specific Antigen prostatectomy

Chemistry

PSA PSA PSA is the only tumor marker which can be used to
screen for prostate cancer when used in conjunction
Prostate Specific Antigen with a DRE(Digital Rectal Exam)
Turbo Assays

CK-MB RCK Used as an aid in patient management and the
assessment of prognosis of myocardial infarction
(AMI)/heart attack
Myoglobin RMY A protein secreted into the blood stream during a

(AMI)/heart attack
Intact PTH RPT Parathyroid gland located next to the thyroid.

Parathyroid hormone regulates calcium and
Parathyroid Hormone phosphorus metabolism.
Troponin , RTI A protein secreted into the blood stream during a

(AMI)/heart attack
Human Chorionic RCH Used for the quantitative measurement of human

Gonadotropin chorionic gonadatropin (HCG) in serum and for
strictly qualitative determinations in urine, as an aid
in the detection of pregnancy

Assay Information
Other Assays

Adrenocorticotropic ACT A hormone produced by the pituitary gland. Used
Hormone as an aid in assessment of adrenal insufficiency and
hypersecretion. Elevated in Addison’s disease
Beta-2 Microglobulin BMG Used as an aid in the diagnosis of active

rheumatoid arthritis and kidney disease
Cortisol COR Cortisol stimulates the breakdown of protein and

fat. Used as an aid in clinical assessment of adrenal
status. Used in the diagnosis of Addison’s (and
Cushing’s disease)
C-Reactive Protein CRP Used as an aid in the evaluation of the amount of

injury to body tissue
Human Growth Hormone GH Used as an aid in patient management and

diagnosis of various forms of inappropriate growth
hormone secretion which can cause dwarfism,
unattained growth potential, gigantism and
acromegaly
Veterinary

Canine Total T4 K9T The principal thyroid hormone. Used as an aid in
(Thyroxine) the clinical assessment of thyroid status
A hormone produced by the

thyroid glands
Canine TSH TK9 TSH stimulates the thyroid gland to release free T4
and T3. Used to determine thyroid status. Also
used in monitoring thyroid replacement medication.

Chemistry
Application Kits

Rat TSH TSH Used to test for thyroid function in rats. Use in
conjunction with Third Generation TSH.
Available Outside the USA*
Allergy

Animal Allergy AP Used as an aid in the clinical diagnosis for an
allergy to animals.
Eosinophils ECP Measures a protein that indicates the level of

eosinophil (a type of white blood cell found in the
blood) activity Used to monitor active
inflammatory diseases such as bronchial asthma,
rhinitis(inflammation of the mucous membrane of
the nose), parasitic and bacterial infections and
chronic fatigue syndrome
Grass Allergy GP Used as an aid in the clinical diagnosis for an

allergy to grass
Mold Allergy MP Used as an aid in the clinical diagnosis for an

allergy to mold
Tree Allergy TP Used as an aid in the clinical diagnosis for an

allergy to trees
Weed Allergy WP Used as an aid in the clinical diagnosis for an

allergy to weeds

Assay Information
Bone Metabolism

Osteocalcin OST Used as an aid in monitoring mineral and bone
metabolism (bone protein). Elevated in
osteomalacia, Pagents disease of the bone,
hyperthyroidism, primary hyperparathyroidism, and
renal osteodystrophy. Also elevated in
postmenopausal osteoporosis.
Cytokines

IL-β 1B Used as an aid in the clinical assessment of various
immunological diseases. Used for the monitoring
Interleukin - 1 and diagnosis of bone diseases, inflammatory
diseases and various types of cancer.
IL-2R 2R Can be used as a marker for diagnosis therapeutic

evaluation and management of cancer as well as an
Interleukin - 2 indicator of a wide spectrum of disorders involving
immune activation.
,/-6 I6 Elevated levels may occur in different diseases

including sepsis, autoimmune diseases, and
Interleukin - 6 lymphomas, AIDS, alcoholic liver disease and in
patients with infections or transplant rejection.
,/ I8 Elevated levels are reported in various diseases

including psoriasis, cystic fibrosis, idiopathic
-8 pulmonary fibrosis, pleural disease and rheumatoid
arthritis
Interleukin - 8
TNFα TNA TNF levels may be elevated in sepsis, autoimmune

diseases, various infectious diseases and transplant
Tumor necrosis factor rejection. TNF acts on the regulatory regions of the
brain to induce fever.

Chemistry
Drugs of Abuse

Nicotine Metabolite NM Used as an aid in distinguishing tobacco smokers
from non-smokers
Infectious Disease

Helicobacter pylori IgG HPG Helicobacter Pylori is a bacterium associated with
gastric and duedenal ulcers and chronic gastritis.
(H. pylori) Used as an aid in the determination of serological
status of Helicobactor. Pylori. A spiral-shaped
bacterium that is found in the stomach mucosa of
infected individuals.
Helicobacter pylori Semi Helicobacter Pylori is a bacterium associated with

Quantitative IgG gastric and duodenal ulcers and chronic gastritis.
Used as an aid in the determination of serological
(H. pylori) status of Helicobacter. Pylori. A spiral-shaped
bacterium that is found in the stomach mucosa of
infected individuals.
Anti-HBc ABC Antibody to the core antigen (HBc) is first

detectable during the onset of clinical symptoms
and remains elevated for years.
Anti-HBc IgM BCM An indicator of acute HBV infection. The titer falls
as recovery occurs.
Anti-HBs ABS Antibody to surface antigen (HBs) is an indicator of

recovery and immunity and vaccinations.
Hepatitis B Surface HBS HBsAg is the first marker to appear and indicates
Antigen an active infection (either acute or chronic)
(HBsAg)

Assay Information

Hepatitis B Surface Antigen A test used to confirm the presence of Hepatitis B
Confirmatory Surface Antigen in blood after HBsAg screen is
positive
Herpes I & II IgM HEM Used as an aid in the determination of an active

state of HSV I & II infection
Rubella IgM RUM Used as an aid in the determination of an active

state of Rubella (German Measles)
Toxoplasma IgM TXM Used as an aid in the determination of an active

state of Toxoplasmosis. Toxoplasmosis is an
organism that is most frequently transmitted
through ingestion of inadequately cooked meat.
Domestic cats have been implicated in the
transmission of the disease.
Reproductive Endocrinology

Free Beta HCG FBC Found in the blood and urine during pregnancy and
is secreted by the placental tissue. Used as an aid
in the diagnosis and monitoring of trophoblastic
diseases (moles, choriocarcinoma and certain
testicular tumors.)

Chemistry
Tumor Markers
A tumor marker is a protein that can be associated with a particular form of cancer.

BR-MA (CA15-3) BRM Used as an aid in the management and the
assessment of prognosis of breast cancer. Used to
follow the clinical course of breast cancer, detect
metastatic disease progression and monitor
response to therapy
Cytokeratin 18 CKN Cytokeratin 18 is produced by malignant epithelial

cells. Levels reflect tumor cell activity
GI-MA (CA19-9) GIM Used as an aid in patient management in pancreatic

cancer, colon cancer and hepatobiliary cancer
Free PSA FPS Used with Total PSA to help distinguish between
benign prostatic hyperplasia and cancer. A lower
percentage of Free PSA indicates prostate cancer; a
higher percentage of Free PSA indicates benign
prostatic hyperplasia.
TPS TPS Malignant epithelial cells produce cytokeratin 18;

levels reflect tumor cell activity. Used in
management, monitoring and prognosis of patients
with breast cancer, ovarian cancer, lung, prostate,
bladder and gastrointestinal cancer

Chapter 3. General Troubleshooting
3.1 General Troubleshooting Tips
• Get as much information from the customer as possible regarding what occurred before,
during and after the problem (specific questions that can be asked are listed in the following
worksheets)
• Remember that different error messages are displayed in different places. Some are
displayed only on the IMMULITE One instrument display panel and ARE NOT printed or
posted to the error log. Other errors will display for 1 cycle on the monitor, will print and
will be posted to the error log. For instance, “Part A reagent missing” will appear on the
IMMULITE One display if a reagent wedge has gone to zero tests remaining. It will not be
printed and will not appear on the monitor or in the error log. However, “no reagent for TSH
tube at barcode reader” will appear on the monitor for 1 cycle, will print and will appear in
the error log. Ask the operator what they have observed in all of these places. Remember
that they may not have seen an error posted to the monitor or on the IMMULITE One display
screen as they are only there for 1 cycle.
• You may see multiple errors posted for the same condition. For instance, “Shuttle spinner
pumps shutdown” may be posted, which is a very general message, often a RESULT of
another condition. It generally will be associated with a more specific error that describes the
problem that created the shuttle spinner pump shutdown. Make note of all errors.

General Troubleshooting
3.2 Assay Troubleshooting Worksheet
What is the problem? When did the problem start?
Any activity other than usual daily activity?
Monthly maintenance? Decon? New water source?
New operator? Move? Service?
Software Upgrade??
What error messages?
On the screen? In the error log?
On the print out? On the Instrument display?
What other tests have you run since problem started?
Kit Type & lot#
New Kits?
New Kit Lot?
Control type and lot#? New lot# ? Crossover performed?
Manufacturer’s Ranges or establish your own?
How were the ranges established? (We suggest a minimum of 20 data points over a minimum of
3 kit lots)
How is the QC recovering for them?
Targets Recovery CPS
Date of last adjustment? First adjust or Readjustment
Check previous adjustments – what is different?
Slope Intercept
P1 Avg Slope Low adjuster CPS High adjuster CPS
Sample CPS?

Are you running now?
3.3 Are you running now?
Did something change in the middle of the run?
Instrument Operator Assay
Any error messages? Aliquot or fresh controls today? Read insert for special handling
Different Sounds? Look different? How long has substrate been on the Adjustors, controls, patients, working
unit? solutions?
Water & Probe wash
How many samples run? Revised control ranges
How much?
Any additional maintenance or service? Important Notices
Where are the bottles located?
Storage of controls , adjustors, Technical Bulletins?
Bubbles in lines? diluents?
Studies?
Lines Switched Where & how stored?
Shake test Frost free refrigerator?

Compare to stability data?
When filled? Replaced? Cleaned? Receiving?
Kit release data?
Syringes – barrel & thumbscrews How long in use?
Biorad QAP data?
Bubbles in syringes Within dating?
Probe fitting Probe bent? Describe how they are used

When was the kit received?
Check spin – movement of bead How are supplies received?
When put into use?
Wash well – fluid/pink? Kits?
Expiration Date?
Substrate dispense – spike or filter
Open kit component stability?
Missing or double o-rings on spike? What QC ranges are on the print out?
Change in kit lot?
Water dispense New control lot?
New kit lot?
Check Test units – bead & sump Change in control lot?
Last decon date? How were the control targets

established? Adjustment history
Change in water source?
How long have the targets been in use?
Macrovalve & microvalve pushed in
and locked? Export data- adjustor/controls- look at
CPS, mean, SD, %CV
Last time end of line filters changed?

3.4 Final Documentation in Clientele
The following should be included in the Clientele report:
1. Instrument type
2. Date
3. Id and Lot Numbers
4. Name, address and phone number
5. Nature of Complaint
6. Dates and Results
7. Plan of Action
8. Corrective Action
9. Reply to complainant
10. Software version (if applicable to the issue)
Are you reporting results???
Is QC performing as per lab SOP? What is the lab’s QC SOP?
What further action is needed??
Is the customer satisfied??

CPS Troubleshooting
3.5 CPS Troubleshooting
Constant CPS = water/ probe wash / substrate
Low Counts (something missing) High Counts (something added) Erratic Counts (imprecision)
0 counts = no PMT, blown F1 fuse, No water (exponential intercept) Poor substrate delivery (low to normal)
defective prescaler
No wash/spin Probe and/or Pump
10 – 100 = no test unit
Contamination (exp intercept) Syringe tips
<50 = no substrate
In water source Bubbles
100 – 1000 = substrate dispense
In probe or pump Probe bent or loose (low to normal)
2,000 – 25,000 counts =
In wash well Probe positioning or level sensing
No reagent (counts – 7,000)
level sense failure, reagent position First tube of a run – valve #2 No probe wash (carryover =higher)
Residual probe wash (slopes 2 – 5) Adjuster problem (exponential No water or inconsistent volume dispense
Contamination (inhibitors/interference) Intercept, for competitive assays) Probe wash and water lines reversed
No sample pipetted Substrate contamination Insufficient spin/wash (intermittent)
Thumbscrew/barrel on small syringe Test unit storage- if bag is left open,

moisture can effect bead and can
Wedge position or cap on reagent cause imprecision. Refrigerated test
unit bags should remain closed until
Film or bubbles in wedge they reach room temperature.
Film, bubbles in sample cup
Substrate contamination
Adjustment Bad / QC ok = chase reagents, contamination
Adjustment Bad / QC bad = chase adjustors

CPS = (slope) raw counts + intercept
ACCURACY PRECISION
How close the average measured value is to the true Repeatability

value
Adjustment Pipetting – syringes
Lot changes Probe
Maintenance / Decon Bubbles
Controls / Control Ranges / Reconstitution/Storage Water
Reagent Expiration Dates Valves
Attenuation Factor / PMT Factor Contamination
Contamination

3.6 Investigation of QC/Assay Issues
Were Controls/Patient Samples Re-run???

When did Problem Start???
Which Assay(s) Affected? Patient Values Showing Same Problem? When was Start-Up Done Last?
Lot Number? New Kit? Error Messages? (Go to Log) Changes to Instrument (water source?)
Date Rec’d/Opened? Collection & Handling? Decon or Maintenance Done?
Same Bias on Previous Lot? Where were Samples Located in Run? Changes made by TSR or FSE?
Other Assays Run? Which Controls ? Control Levels Affected? Were Samples Diluted? Handling/Storage
QC for Other Assays? Manufacturer? All Values in Same Direction? Auto (2000) or Manual Dilution? Rg Left on Instrument or Poured Together?
Anything Running Now? Expiration Date? When was QC First Started? What Diluent was Used? Frost-free Freezer?
New QC Lot in Use? Inter-lab Comparison Data Available? What was Dilution Factor? # of Operators Involved?
Adjustment Date & Frequency? Ranges Used? Testing Time Frames? Was Error Log Checked?
First Adjustment? (QC in range?) How Established? # of Points? Elapsed Time between Repeat Runs? Any Unusual Sounds from Instrument?
Slope/Intercept? Handling of Adj? Multiple Lots Used? Was an Adjustment done In-between? What Version of Software Installed?
Counts on Replicates? Comparison to PI? Sporadic Poor Recovery or Entire Run?
Handling/Storage?
Rg Left on Instrument or Poured Together?
Frost-free Freezer?
# of Operators Involved?
QC Reconstitution?
Storage Container? How Much/Vial?
Same Water as used on System?
Date Reconstituted?
Is Customer Complaint Confirmed by:

Kit Release and/or Stability Data?
Important Notice?
Technical Bulletin or Customer Notification
3.7 Non-Mechanical Troubleshooting Tips
Where do I begin to troubleshoot a non-mechanical problem? Get specific information.

Remember, the better we characterize the problem, the more quickly and accurately we can solve
it!
1. Which assay(s) are they having a problem with?

2. What do I know about this assay? Are there special handling requirements for the adjustors
and/or controls? Has there been an important notice recently with updated control targets?
Was information about this assay given on the Monday conference call? Has there been a
recent chemistry study done regarding this assay, and what was the outcome of that study?
What is the adjustment interval for this assay?
3. When did the problem with the assay begin exactly, and what is the exact nature of the
problem? Specific information is necessary!
4. When did the customer last adjust the assay? What were the slope and intercept of that
adjustment? How to these compare with the previous adjustment for this assay? What were
the QC results after the adjustment? What is the slope range for the customer’s instrument?
How were the adjustors stored/handled?
5. What are the controls that the customer uses for this assay? What is the lot number? What
are the ranges? How were these ranges established? Is this a new lot of control material?
Do these controls require special handling? How were they stored? How many days old are
the controls (if refrigerated)?
6. Are there problems or trends with other assays? Remember, get specific information. What
were slopes and intercepts on adjustments done during the same timeframe as the problem
assay? What are the control results on these other assays, both after the adjustment, and on
the day in question for the problem assay? Is the same control material used for all the
assays under discussion? Were the adjustors stored under the same conditions?
7. When was maintenance last done, and what was done? Was any of this maintenance done
just prior to the appearance of the assay problem? Is there a new water source? Was the
probe wash prepared correctly?
8. Is this a new assay on the IMMULITE?
9. What was the previous kit lot number in use in the lab? Have they skipped a number of kit
lots? Were there important notices and/or technical bulletins dealing with a change made to
a kit lot that was not used in this lab? What is the software version in use? Is this an assay
that requires the latest software update?
10. Is the customer’s problem confirmed by the stability data?

Patterns in data
3.8 Patterns in data
Remember: CPS x slope +intercept
For any given assay, if the slope and intercept of the adjustment are outside the guidelines, but
the control results are acceptable, the problem lies with the reagent.
For any given assay, if the slope and intercept of adjustment are outside the guidelines, and the
control results are not acceptable, the problem lies with the adjustors.
For any given assay, if the slope and intercept of adjustment are acceptable, but the control
results are not, the problem lies with the control material.
Low CPS
If the CPS are too low, something is missing. Look for errors in sample or reagent pipetting, or
with substrate dispense.
Low CPS may also be an indicator of problems with the substrate itself. This is easy to
investigate by running a water test to see the CPS of substrate alone.
Contamination can also cause low CPS. Check the location of the water bottle on IMMULITE
One systems, as well as the water source on both systems. Is it sitting in the sunlight or under a
heating vent?
High CPS
If the CPS are too high, suspect problems with the spin or with the wash of the bead. Unbound
material is left behind, adding to the CPS.
Contamination can also cause high CPS.

3.9 Chemistry Troubleshooting Tips
3.9.1 Control/Adjustor Problems
If a control problem occurs immediately after an adjustment
• Is this a first adjustment or a re-adjustment?

• What are the slope and intercept, the slope range, the previous slope and intercept on this kit
and/or assay?
• Get kit lot and control lot information
• Get control ranges being used at the facility- are they package insert ranges or established? If
established, how?
• Ask about adjustor and control handling: new vs. frozen adjustors/ freshly reconstituted
controls vs. frozen aliquots/liquid vs. lyophilized adjustors.
• If using frozen aliquots, check on freezer- is it frost-free? If so, it will go through
freeze/thaw cycles, which can effect the stability of controls and adjustors. Also, how large
are the aliquots?
• Check the CPS on controls before and after adjustment. If CPS are similar, readjust. If CPS
are different, run new controls.
• If the slope/intercept are questionable and/or not comparable to the previous adjustment, try
new adjustors, then a new kit.
As a general rule, small molecules are less prone to degradation during storage of
controls/adjustors. Therefore, control or adjustor problems are more important in sandwich
assays. The following assays are known to be effected by unstable analytes (4/2000):
ACTH
iPTH
Prolactin
C-peptide

Chemistry Troubleshooting Tips
If a customer complains about a problem with a control not currently assayed/evaluated in

DPC QC
Proceed with the regular troubleshooting process: get stability data; check QC on other assays;
get adjustment data; check if this is a new lot number; check QC ranges being used and ask when
the ranges were established and with how many data points; check QAP data if available. In
addition, the following can be done:
• Check any important notices/tech bulletins for any updates that may effect the customer’s un-
assayed control material.
• Send DPC controls to customers to assess if the problem is systematic and not limited to one
control. If the DPC controls come in though, the problem is not solved, since it has to be
found out why the unknown control deviated in the first place.
• Get the control the customer is using, either from chemistry or from the customer and have it
run here.
• If this is not possible, get the customer a control (e.g. a lot BioRad lot available here) similar
to what they are using.
• Investigate any reported or assumed shifts with that control to look for similar shifts in the
controls used in QC. The control used for that purpose should be run in a range close to the
range of the affected control and be preferably from the same manufacturer.
Adjustor Handling Issues
Check current versions of package inserts, important notices and technical bulletins for current
handling recommendations (4/2000).
Some specific handling requirements:
• PTH- single use- use on ice

• Ferritin- Never freeze
• PRL, DHS- Always freeze

3.9.2 Water Issues
Water issues are tough to identify and hard to sell to the customer, and are usually seen in more
than one assay, often described as control “drift” or “adjustments not holding”. Fixing a water
problem is relatively time consuming and labor intensive. This leads to occasional delays in
addressing water issues. The following sequence of actions is suggested:
Try:
Fresh controls
Fresh adjustment
Fresh kit
Decontamination
Try not to change too many parameters at one time, if possible. You may resolve the problem but
won’t be able to determine or narrow down the cause. You must use discretion. It is important to
resolve the problem in a timely, yet effective manner.
At the same time, explore water information…get source information- i.e. is this a new water
source, is the source bottled/filtered etc. Determine if they fill bottles with an intermediate
container that may be contaminated. Check with TSR about what brand of bottled water works
best in his/her region. Also, explore decontamination frequency and what is used for the decon.
A watertest at this time is not always helpful; even if the watertest does not suggest a problem, a
decon may have to be performed anyway.
If the problem persists, the water source would be one of the suspects. In this case, the
troubleshooting process is usually going on for quite a while and the customer tends to be
frustrated. It should be considered to try a new water source. Any new water source must be
tested with watertest (watertpm is not necessary). Remember, putting “bad” water back into a
clean system will allow the problem to persist.
Assays frequently affected by water issues are (4/2000):
hCG Progesterone
Testosterone TSH
PTH PSA
Folate Vitamin B12
E2 ATA
ATG

Chemistry Troubleshooting Tips
Instructions for Substrate Decon
When performing watertpm, and substrate only CPS are >10,000, then substrate decon should be
performed, provided new watertest test units have been used.
FSE will provide account with 3 vials, one of NaOH and two with distilled water.
First, remove and discard old substrate. Prime substrate until reservoir is empty using the
SOLE2S diagnostic. Run until dry. Limit pump time to 5 minutes.
Note: Make sure shuttle is in the “home” position before starting Decon.
Next, place bottle containing NaOH on spike. Fill reservoir using gray prime button (remember
to gently squeeze the button between two fingers…don’t press the button). Float should be
about ¾ of the way up.
Prime using SOLE2S, no longer than 5 minutes. Let NaOH sit for 20 minutes.
Run SOLE2S in 5 minute intervals to empty the remaining NaOH in the bottle, allowing the
pump to rest for 5 minutes after running it for 5 minutes. When the bottle containing substrate is
empty, replace with bottle of DI water. Fill reservoir again and prime using SOLE2S, again
running and resting the pump in 5 minute alternating intervals. When empty, place the second
bottle of DI water on spike and run SOLE2S. Limit pump time to 5 minute intervals, with 5
minute rest period. When last bottle of water is empty, replace substrate spike with a new one.
Place new bottle of substrate on spike. Fill reservoir and run SOLE2S for about 1 minute
Run watertpm to check the substrate CPS.
3.9.3 Testing for precision
To test for precision when a wash issue is suspected
Use the TSH low adjustor, the TSH 0 calibrator or the IMMULITE One TSH sample diluent.
Any deficiency in the wash will show up immediately. Typically, the precision of a 0 runs
around 7%CV. Pipetting imprecision (microvalve, thumbscrew, air bubbles) will not necessarily
affect the precision of a zero sample in a sandwich assay.
To test for pipetting imprecision
Use an assay, preferably a sandwich rather than a competitive assay, with low sample volume
(and preferably lower CPS- i.e. DHS is a 5µl sample volume but low adjustor counts are in the
100,000’s), a sample (control or adjustor) with a concentration in a range usually yielding good
precision. HCG low adjustor or diluent is recommended.

To test the precision of a specific assay and to compare it with that assay’s current performance
Run a sufficient number of replicates (typically 20) and compare to kit release precision. If
necessary, initiate a study in chemistry to test the precision. Check the CV% of adjustor
replicates for the assay(s) in question and for several other assays. This will provide an overall
precision check on the instrument even before any specific precision testing is done.
3.9.4 B12 and folate
If B12 or folate show low control results, check the volume used in the respective sample cup.
Remember that a dead volume of 250 µl has to be used. Using less can lead to undetected short
sampling, resulting in low results. Also, the Folate working solution can be used with both the
B12 and Folate assays, however, the B12 working solution cannot be used with the Folate assay.
3.9.5 Left over test units
Left over test units can be caused by a wrong entry in the configuration table (dead volume set
too high), by evaporation or by handling errors:
1. Evaporation will happen with low volume assays, reagent wedges being kept on the
instrument uncapped and seasonal patterns can occur. The evaporation rate for uncapped
reagents in the carousel is about 1.5 test units per shift (about 75 µl). They are caused by a
combination of low humidity and throughput. A good way to track this is to have a customer
keep a test remaining log…when they start a new box, have them log the tests remaining in
the wedge before logging off each day (remind them that it is an estimate, accurate within 4
tests). The number of tests decremented each day should closely reflect the number of tests
run for that assay. If not, suspect evaporation. The only fix for that problem is to take
reagents not in use off the carousel, cap them and store them in the refrigerator.
2. Common operator error: Spillage, sucking out air bubbles and taking reagent with it.
3. A wrong entry in the configuration table will result in a low number of tests left displayed on
the main screen when a fresh kit is pipetted the first time. It will typically happen after a
change (e.g. a new level sense PCB) has been made to the instrument. Field service is
adjusting the dead volume now after changing the PCB. Refer to Pipettor module for
guidance in adjusting dead volume.

Typical IMMULITE problems
3.10 Typical IMMULITE problems
Symptoms and Possible Causes

SYMPTOM: Air in the fluidics system
• Possible Causes:
• Clogged end of line filters; install new filters and run PRIME for 10 minutes
• Loose fittings
• Worn syringe tips
• Bad micro or macro valves
• Empty water or wash container
• Kinked or broken intake tubing
• Worn flair on bottle cap or tubing ends
SYMPTOM: Water solenoid pump is noisy at start-up
A slight air leak has occurred at the input to the pump due to a loose fitting or a particle
preventing the proper seating of the tubing flare in the pump fitting. Pump may have stopped
functioning.
SYMPTOM: Level sense errors due to splashing
• Probe is dispensing on an angle due to bent or damaged probe
• Probe dispense velocity is too great
• Pipettor is not centered in the home well
• Depth of pipettor is incorrectly set in the home well
• There is air in the system

SYMPTOM: Test units remain after reagent is used up
• Operator removes reagent when trying to remove air bubbles from the surface of the
reagent
• Ambient humidity may be excessively low (arid climates)
• Configuration table entry incorrect
SYMPTOM: Reagent level sense error followed by "Are there caps on the reagent?"
• The level sensor has sensed reagent at an elevation >150 tests left for one of the following
reasons:
• The caps are still on the reagents. (220 tests remaining) (new wedges might cause this)
• The reagent wedge is mis-positioned in the tray, or there is a bubble on the surface of the
reagent (180-200 tests)
• The water has splashed onto the probe guide arm
• The probe is loose and not making a good electrical connection with the probe block.
SYMPTOM: Bad reagent bar code reads
• Wedge is incorrectly placed in the tray
• The bar code label is obstructed by a substance
• Condensation on label
• Barcode label is mis-positioned- remove and reposition (down and to the right)
• The barcode label is too shiny- try wiping with kimwipe or rubbing with pencil eraser to
dull it
• The probe cleaning wedge is still on the tray
• Large amount of condensation on the reagent carousel

SYMPTOM: Bad test unit and sample cup bar code reads
• Worn or dirty drive "O" ring
• An idler roller not moving very smoothly
• Worn idler "O" rings; the return spring has mis-positioned
• Bar code label is faulty
• Powder from gloves is getting onto barcode reader LEDs
• Bar code reader motor speed is too slow or too fast
• Bar code reader motor is bad and/or PCB
SYMPTOM: Insufficient water dispensed into the test unit at the wash position
• Defective water solenoid in the injector pump
• Air leak in the input line to the pump
• Insufficient water supply
• Clogged water filter
• Input water line is crimped
• If customer has not run in awhile the water pump valve dries up; submerge water nozzle
into clean beaker of water- gets valve wet and creates a good seal to get water to pump
through consistently.
SYMPTOM: Insufficient Substrate dispensed into the test unit
• Clogged substrate nozzle
• Reservoir was never primed
• Pump was never primed
• The tubing connection at the top of substrate heater is allowing air to enter and substrate
to drip out of the nozzle
• Test unit not aligned under nozzle

• Clogged air filter in the substrate spike

• Defective substrate solenoid in the injector pump
• Loose connection to substrate pump- watch for leakage into power supply
SYMPTOM: Insufficient substrate dispensed for first several test units
• The fitting at the top of the substrate heater was over-tightened or is stripped and
substrate leaked out
• Tubing at top of substrate heater was removed, thus emptying the tubing in the heater
• Substrate nozzle was not cleaned/primed
SYMPTOM: Calculation Error
CPS < 5000
• Air in fluidics system
• Bubble on sample
• Low substrate
• False level sense
SYMPTOM: Negative CPS
• Extremely high dark counts (above 1000)
• Blown fuse
• Bad Parity

SYMPTOM: Low counts
CPS = 0
• PMT is defective or not connected
• Prescaler is defective
• PMT power supply fuse (F1) is blown
• PMT multiplier factor was never set
SYMPTOM: Low counts
CPS = 10 to 100
• Possible Cause: No tube in front of PMT for one of the following reasons:
• Tube fell off of shuttle
• Luminometer chain has mis-positioned
SYMPTOM: Low counts
CPS = 100 to 1000
• Possible Cause:
• No or little substrate dispensed
SYMPTOM: Low counts
CPS = 2000 to 20000
• Possible Cause: No reagent pipetted for one of the following reasons:

• The wedge being placed into the tray incorrectly
• False level sensing
• Mis-positioning of the reagent carousel
• Bubbles in reagent wedge
• Loose probe

SYMPTOM: Low counts
CPS > 25000, but much less than normal
• Probe wash has gotten into the test unit- either from residual probe wash in water bottle
or faulty V2 causing probe to drip probe wash
• Substrate reservoir is contaminated
• No sample pipetted
SYMPTOM: Dose is lower than expected for a sandwich assay or higher than expected for
a competitive assay
• Air bubble on top of sample resulting in insufficient sample
• Defective Valve #1 or Valve #4 causing insufficient sample to be aspirated
• Contamination
SYMPTOM: Intermittent high counts
• Test unit did not spin well or not at all. (Check for spinner errors)
• Test unit was "flicked"
• Upper shuttle slide bearing is sticky causing tubes to misalign in spinner or under
substrate nozzle.
• Intermittent problem with wash/water dispenses.
• In sequential assays, water dispense volume is set too greater than 200 uL, allowing the
sump to overflow back onto the bead.

SYMPTOM: Intermittent low counts
• "Shuttle at luminometer" sensor flag is bent causing test unit to mis-position under
substrate nozzle
• Substrate solenoid has excessive "drawback" causing part of the substrate stream to
dispense off-center
SYMPTOM: Consistent high counts
• Water is contaminated
• Ran out of water
• Substrate is contaminated
• High speed spinner is no longer spinning
• Incorrect PMT factor
SYMPTOM: Intermittent low counts
• Level sensor is stopping before reaching sample
• Sample cups are tipping in sampling positions causing probe to mis-position in cup
• Attenuator sensor disk is loose causing attenuator windows to mis-position
• Probe is loose
• Incorrect PMT factor
• Substrate nozzle is partially clogged causing substrate to dispense off-center

SYMPTOM: Intermittent Very low counts
• Insufficient substrate dispense due to improper seating of the tubing flare in the connector
at the top of the substrate heater.
• Insufficient substrate dispense due to blockage of the nozzle.
SYMPTOM: Load Chain errors
• Excessive spillage of sample onto chain has caused links not to flow smoothly
SYMPTOM: Load Chain not moving
• The sample tray is full
• A baffle has dislodged and is jamming the chain
• The sample cup holder or test unit has tipped and is jamming the chain
• Sample cup is stuck in star wheel
• Incorrect sample cup type has been placed in the sample cup holder.
• Fuse F3 blown
SYMPTOM: False Tip Jam errors and/or level sense errors
• Tip jam sensor wires have broken
• Tip jam sensor is not connected

SYMPTOM: Reagent Carousel temperature is high
• TED is defective
• TED connector is corroded
• Reagent lid opened for an extended amount of time
SYMPTOM: Probe wash container is not emptying
• Valve #2 is not activating
• Clogged filter
SYMPTOM: Probe wash container is filling
• Valve #2 is always energized
SYMPTOM: Probe is dripping when going for sample
• Valve #4 is always energized
• Fitting is loose
SYMPTOM: Probe is dripping when instrument is idle and probe wash bottle is elevated to
the top of the instrument
• Possible Cause:
• Valve #2 is not sealing properly

SYMPTOM: Shuttle is not moving to the correct position
• A Luminometer chain baffle has become dislodged and is interfering with the shuttle
movement
• A sensor has become dislodged or has failed
• A tube has fallen into the path of the shuttle and has broken the shuttle flag
SYMPTOM: Shuttle position errors at start-up
• The instrument was improperly stopped leaving the shuttle in the path of the
Luminometer chain
• The Shuttle at Luminometer sensor flag is broken
SYMPTOM: Shuttle at Luminometer sensor flag is bent or broken
• Possible Cause:
• The waste container has overfilled or is improperly installed resulting in test units falling
into the path of the sensor flag
Note: Shuttle flag is covered to protect it.
SYMPTOM: Luminometer chain is not moving
• An assay tube has become jammed inside the Luminometer thus jamming the chain
• The shuttle is mis-positioned and interfering with the chain
• A Luminometer chain baffle has dislodged and is interfering with the chain
• F3 fuse blown

SYMPTOM: Bottom of Reagent Carousel has an excessive amount of liquid
• Reagent has been spilled
• Waste tubing has kinked causing liquid to back up into reagent carousel
• The waste container air filter has clogged causing a pressure build up preventing liquid
from flowing into container (air filter should be removed; it is not necessary)
• Waste fitting clogged
SYMPTOM: No Power
• No power to the PMT - Fuse #1 is blown
• No communication- Fuse #2 is blown
• No power to motors- Fuse #3 is blown
• No power at all – Fuse #5 is blown
SYMPTOM: Syringes not moving
• Power interruption disrupts communication between CPU and the dilutor (pump)
assembly
• Syringes have not been installed

3.11 Precision or Accuracy
• Imprecision: When the difference in CPS (CV) between replicates is greater than expected.
• Inaccuracy: When the level of CPS generated is incorrect, therefore the dose is incorrect.
3.11.1 Possible causes of precision problems
Symptom: General Imprecision CPS Higher or Lower than expected
All Assays Affected
• Bubbles in small syringe

• Worn small syringe tip
• Poor X pipettor alignment of probe in sampling cups
• Loose or bent probe
• Intermittent valve failure
• Partially clogged substrate nozzle
• Poor alignment of test unit under substrate nozzle
• Inconsistent volume of water dispensed
• Intermittent high speed spinner problems (i.e. inconsistent wash speed)
• Loose syringe thumbscrew or barrel
Symptom: CPS Higher Than Expected
All Assays Affected
• Sticky upper shuttle slide bearing

• Worn high speed spinner "O" rings
• The pressure on the tube in the shuttle is not set properly
• Test units not aligned with entrance to Luminometer (tube flick)
• Inconsistent spinning of high speed spinner motor
• Alkaline phosphatase contamination (water and/or system)

Precision or Accuracy
Symptom: CPS Lower than expected
All Assays Affected
• Attenuator sensor disk set screws loose

• Reagent carousel tray platter set screws loose
• Inconsistent level sensing failures
• Probe is loose in pipettor arm
• Probe is bent
• Probe wash has gotten into the test unit- either from residual probe wash in water bottle, a
faulty V2 causing probe to drip probe wash, or not following a DECON with DECON1 to
thoroughly rinse probe wash
• Small syringe tip is worn
Only Specific Assays Affected
• Sample cups tipping while in sampling position (tube guides too close)

3.11.2 Possible causes of accuracy problems
Symptom: General Inaccuracy
CPS Higher or Lower than expected
All Assays Affected
• Substrate contamination
• Incorrect PMT Multiplier
• Loose syringe thumb screws
• Incorrectly prepared or handled control material
• System/H20 contamination
• Loose probe
Symptom: CPS Higher Than Expected
All Assays Affected
• No water dispensed from the injector pump

All Assays Affected
• No substrate dispensed
• Consistent valve failure
• Non functional PMT
• Consistent level sensing failures

Precision or Accuracy
Symptom: CPS inaccurate at High CPS end of Range
All Assays Affected
High End of Sandwich assay working range
Low end of Competitive assay working range
• Incorrect Attenuation Factor
Symptom: CPS Lower or Higher than expected
• Bad Adjustment
• Poor X pipettor alignment of probe in sample cups
• Reagent carousel tray platter set screws loose
Symptom: CPS Higher than expected at
Low CPS end of Range
Low End of Sandwich assay working range
High end of Competitive assay working range
• Water contamination
• Inconsistent spinning of high speed spinner motor

In All Cases...
• If problem is assay specific, examine what is different about the assay that is having the
problem from the assays that are fine.
• Find out when the problem started and what, if anything, has changed such as:
• New water source
• New kit lot
• Recent service performed on instrument
• Software change
• Change in primary operator

Precision vs. Accuracy Grid
3.12 Precision vs. Accuracy Grid
Troubleshooting precision and accuracy problems
• Is the problem accuracy or precision?
Imprecision: When the differences in CPS (CV) between replicates is above normal.
Inaccuracy: When the level of the CPS between replicates is incorrect.
To read the chart below: First, on the left hand side of the chart, determine if the CPS are higher
or lower than expected…you will notice that there are 2 rows for each scenario. Next, on the
right hand side of the grid, determine if the high CPS or low CPS end of the assay is
effected…again there are two rows for each scenario. This will narrow your final choices to two
possible boxes. Finally, in the center of the grid, determine if all assays or just specific assays
are affected. This will reduce your search to one final numbered box. Refer to the charts on the
next two pages, one for accuracy problems and one for precision problems…any box in the far
right hand column that lists your number from the grid is associated with a possible cause for the
problem.
Possible Precision and Accuracy Areas
Affects Specific
Affects All Assays Assays
CPS Higher Than High CPS End of

Expected 1 5 Assay
CPS Higher Than Low CPS End of

Expected 2 6 Assay
CPS Lower Than High CPS End of

Expected 3 7 Assay
CPS Lower Than Low CPS End of

Expected 4 8 Assay

• If problem is assay specific, examine what is different about the assay that is having the
problem from the assays that are fine.
• Find out when the problem started and what, if anything, has changed such as:
- New water source
- New kit lot
- Recent service performed on instrument
- Software change
- Change in primary operator
POSSIBLE CAUSES OF ACCURACY PROBLEMS
CAUSE Box Number

Bad Adjustment 5,6,7,8
Water contamination 2,6
Substrate contamination 1,2,3,4
Incorrect Attenuation Factor 1,3
Incorrect PMT Multiplier 1,2,3,4
Incorrectly prepared or handled control material 1,2,3,4
No water dispensed 1,2
No substrate dispensed 3,4
Consistent valve failure ,4
Worn syringe tips 1,2,3,4
Non functional PMT 3,4
Loose syringe thumb screws 1,2,3,4
Reagent carousel tray platter set screws loose 7,8
Poor X pipettor alignment of probe in sample cups 5,6,7,8
Consistent level sensing failures 3,4

Precision vs. Accuracy Grid
POSSIBLE CAUSES OF PRECISION PROBLEMS
CAUSE Box Number

Inconsistent level sensing failures 3,4
Partially clogged substrate nozzle 1,2
Inconsistent spinning of high speed spinner motor 1,2
Poor alignment of test unit under substrate nozzle 1,2
Inconsistent volume of substrate dispensed 3,4
Inconsistent volume of water dispensed 1,2
Sticky upper shuttle slide bearing 1,2
Probe is loose in pipettor arm 3,4
Attenuator sensor disk set screws loose 3,4
Worn high speed spinner "O" rings 1,2
Tube pressure 1,2
Test units not aligned with entrance to luminometer (tube flick) 1,2
Intermittent valve failure 1,2,3,4
Sample cups tipping while in sampling position (tube guides too 7,8
close)
Reagent carousel tray platter set screws loose 3,4
Poor X pipettor alignment of probe in sample cups 1,2,3,4


Chapter 4. Error Message Table
4.1 Error Message Table
Error Message Cause Solution Module
ASSOCIATED
DIAGNOSTICS
Adjustor lots Test Unit lot numbers are not Re-run the Adjustor (or N/A
between the same for all the Adjustor Adjustors) using matching Test
replicates replicates. Unit lots.
don’t match
Adjustor The Test Codes behind an Re-run the Adjustors with N/A
replicates not Adjustor sample cup are not matching replicate Test Codes.
identical all the same (i.e. not all TSH
replicates).
Adjustor result The result file could not be File deleted-Repeat Adjustment N/A
file not found found.
Ambient Elec. The ambient electronics q Clean the intake fan filter N/A
Temp High [nn] temperature reading is higher on the right side of the
than the acceptable range. IMMULITE.
Note: This is not a fatal q Lift the top panel to allow
error condition. the electronics to cool.
-TEMPS
Note: The temperature falls
back into an acceptable
range within a short
amount of time.
Ambient Temp. The internal ambient air This problem should correct N/A
High temperature reading is higher itself.
than the acceptable range.
Note: The lab temperature
should be less than -TEMPS
30ºC.
Atten. Factor The attenuation factor was Check Configurations, Config LUM
not set not set. Settings, PMT Factor
Note: This message should
not be encountered if
the computer has
been configured
correctly.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Atten. Home Appears on the IMMULITE LUMINOMETER
Error Display Panel if the error
corrects itself.
Note: If the IMMULITE
cannot correct the -ATTURN
error, the instrument
automatically shuts
down and an error
message appears.
Atten.-Pos. Refer to the explanation Refer to the solution above for LUMINOMETER
Error. above for the error message: the error message:
Attenuator Home Attenuator Home
Error. Error.
Bad barcode Either: q Wipe the label with a lint- LOAD PLATFORM
last Sample #nn free towel or wash the label
n Torn, wrinkled or dirty
with water.
barcode labels, which
cause Test Units not to q If the barcode is torn or
spin smoothly. wrinkled, discard the Test
Unit or the sample cup
n Dirty Barcode Reader O- -BCODEON
holder.
rings.
q Perform maintenance on -BCODESPD
n Barcode Reader speed is
the barcode drive wheel. -BCODETST
off in one or all
positions. (BCODE)

Error Message Table
ASSOCIATED
DIAGNOSTICS
Bad File Name The computer was turned off q Press any key to return to N/A
or Number in or reset without following the the DOS command line.
Line xx of proper Log Off procedure.
Module PC yy at q At the C:\CIRRUS\IMM
address zz. prompt, type fixit and
Hit any Key to press [Enter].
Return to A message indicating that
System.
the software is attempting
to repair the database will
be displayed until the
damage is corrected.
Note: Some data may be lost
in this process.
q Type start and press
[Enter] to return to the
Start-up menu.
q Repeat all tests in progress.
Note: Be sure to shut down
the Analyzer before
choosing RUN
IMMULITE or
START TURBO. See
Also: Database Needs
Repair
Bad LIS Checksum did not match Re-send results to the LIS. N/A
Checksum (transmission error).
Bad or Missing Usually indicates a bug in the Re-send the results to the LIS. N/A
Frame Number LIS software; however, could
If the error continues to occur,
be caused by a bad message
contact software dept.
(due to line noise, etc.).
Bad Parity Due to electrical noise on the The problem will correct itself. N/A
Error power line, information was
sent to the software and
incorrectly read as a message.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Calc error Occurs when the system q If all results give Calc WATER/
cannot properly calculate a error, check to see if SUBSTRATE
dose. there is enough water and PUMPS
if the syringe thumbscrews
are tight.
q If an individual result
shows this error and it is a
competitive assay, the dose
may be too high. Dilute -DISSUB
and rerun specimen. -DISWAT
q If the results show < -SOLE1W
25,000 cps, refer to page
11-10 for: Erroneous -SOLE1S
results with counts of
2,000 to 25,000 cps.
Cannot An invalid value was q Turn the IMMULITE N/A
calculate received for a temperature power off for a couple
average reading because of a seconds and then on.
temperature due
temperature controller error
to error q Select RUN IMMULITE
or failure.
or START TURBO from
the Start-up menu.
q Put the instrument
manually into the pause
mode.
q Check the temperature
after 10 minutes.
Note: If the Luminometer or
Main Carousel feel hot,
turn the instrument off
immediately.
Cannot An invalid value was Refer to solution above for: N/A
calculate last received for a temperature
temperature. Cannot calculate
reading because of a average temperature
Delta error
encountered. temperature controller error due to error
or failure.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Cannot RUN IMMULITE or q TO SAVE RUN EXIT N/A
communicate START TURBO was TO DOS, ENTER PC
with IMMULITE selected while the Display MODE
Panel showed something
q Ensure the IMMULITE
other than the message: DPC Display Panel reads IDLE.
IMMULITE IDLE, Run
START Program to q Press ALARM MUTE
begin. and GO and re-load the
software.
Note: Make sure the power is
on and the RS232 ports
are connected.
Cannot find A record required for LIS Re-send the test order to N/A
Order Record communications is not found. IMMULITE.
Cannot find The IMMULITE sent a Re-run the test using a different N/A
record for reading to the computer; sample cup holder number.
result Sample however, it did not know
#nn testCode
where the result belonged in
the database and the result for
this Test Unit was lost.
Cannot find The sample cup was Repeat the tests, identifying the N/A
record to place identified as an Adjustor, Adjustor, control, or verifier to
Adjustor control, or verifier after the software before the sample
[Control]
[Verifier] passing the Barcode Reader. cup passes the Barcode Reader.
Entry.
Note: The error
message will
read either
Adjustor,
Control, or
Verifier,
depending
upon the
situation.
Carousel Shut This message appears when Repeat all tests in progress after MAIN CAROUSEL
Down the Main Carousel is disabled the cause of the shut-down is
(i.e. when a shuttle/carousel determined and corrected.
jam is detected).
Note: Any tests in the -CARBACK
Luminometer will -CARPOS
continue if possible.
-EMPTYTUB
-CARSHAKE
-CARCHECK

Error Message Table
ASSOCIATED
DIAGNOSTICS
Carousel Temp. The Incubation Carousel The IMMULITE should correct MAIN CAROUSEL
High [Low] temperature is above or itself.
Note: The error below the acceptable range.
Note: All results generated
message will during the high or low
read either temperature period will
High or Low. be flagged on the
printout.
If the component feels hot, turn
the instrument off, allow it to
cool.
Check LED Pattern on
Motor/Heater board
Collection Tray The sample collection tray is q If the sample collection LOAD PLATFORM
Full full or missing. tray is full, remove the
sample cups from the
Note: An alarm sounds and
collection tray and replace
the IMMULITE goes
the sample collection tray.
into AutoPAUSE
mode. q If the sample collection
tray is missing, replace it.
q Follow the instructions on
the instrument Display
Panel to continue.
q Power down then back up
q Clean sensor flag
<CR> or <LF> Usually indicates a Inform your LIS provider of
Missing in LIS programming bug in the LIS this error.
Transmission. software, but may be a bad
message (e.g. line noise).
Dark Count High The dark count measured LUMINOMETER
[nn]. exceeds the maximum
acceptable limit (300 cps).
Note: The preceding sample -DARKCNT
may have had very
high cps. -BKGNDCNT
-PMTCOUNT

Error Message Table
ASSOCIATED
DIAGNOSTICS
Database needs The computer’s power was q Press any key to exit to N/A
repair in line turned off or reset without DOS.
0 of module following the proper log off
Pcxxx at q Type fixit and press
address procedure.
[Enter]. The message:
xxxx:yyyy. Hit Attempting to
any key to repair database is
return to the displayed, followed by a
system.
message indicating the
damaged files have been
repaired. -FIXDB
Note: This process can take as -CHKDSK
long as 15 minutes, (see FSE)
depending on the
amount of data stored. -CHKDSK/F
q Type start and press -DEFRAG/F

[Enter] to return to the
Start-up menu.
Data lost. The computer and the q Check the RS232 cable. N/A
Simulation IMMULITE were not
screen may not q Save run by Exiting to
communicating for more than
be correct. DOS and running in PC
OLD=[xx], 32 cycles. Some of the data
mode
NEW=[yy] was not received; therefore,
reports will be missing.
Date Time The computer's date or time Do the following: N/A
conflict was set earlier than the date
q Enter the current date
or time recorded with results
and/or time.
already generated by the
IMMULITE. q Re-run the tests.
Diluted Samples Diluted sample is below the Re-run sample undiluted. N/A
below curve detection limit.
Record the CPS of the test
Division by 0 An invalid or 0 cps caused by Check PMT LUMINOMETER
during Adjust either:
testCode
q invalid parameters or kit
barcodes -PMYCOUNT
q mechanical problems -DKCOUNT
Error during Refer to the explanation Refer to the solution below for N/A
Control QC below for the error message: the error message: Error
Error during during Patient QC.
Patient QC.
Error during Unforeseen error . N/A
Patient QC

Error Message Table
ASSOCIATED
DIAGNOSTICS
Error in last The LIS encountered an error Re-send the results to the LIS. N/A
request when processing the
If the error continues to occur,
IMMULITE’s request for
call your LIS provider.
information.
Fatal Curve An unknown error was Check the CPS. N/A
Adjust error encountered.
#nn testCode
Five Replicates More than the required four No action is necessary. The N/A
used for Curve Test Units were run behind software looks for
Adjust. 5th the Adjustor sample cup. quadruplicates only; therefore,
replicate
dropped. the fifth Test Unit is ignored.
Front End Shut The Load Chain and pipettor q Wait for the IMMULITE LOAD PLATFORM
Down are disabled because an error to complete the tests in
was detected in the Load progress.
Chain, pipettor, or syringes
q Investigate the cause of the
which the IMMULITE could
problem by checking the
not correct.
associated error messages
Note: If possible, the or looking for an -LCHAIN
IMMULITE will obstruction. -PROBANGL
continue processing
the tests currently in -PIPXPOS
progress. -PROBTEST
Heaters Shut The 35 or 39 degree Check Motor/Heater LED’s N/A
Down 35 [39] calibration resistor cannot be
Degree Error Power Down/Restart
read properly due to a heater
Note: The error controller error. Check Fans & Filters
message will
read either 35
or 39.
Heaters Shut The incubator carousel heat Check Motor/Heater LED’s N/A
Down is not working correctly
Car. Heater Power Down/Restart
because of a heater controller
Error
error or a thermistor failure. Check Fans & Filters
Heaters shut Reagent cooling is not Check Motor/Heater LED’s N/A
down cooler working properly because of
error Power Down/Restart
a heater controller error or a
thermistor failure. Check Fans & Filters
Heaters shut The Luminometer heating is Check Motor/Heater LED’s N/A
down - Lum not working properly because
heater error Power Down/Restart
of a heater controller error or
thermistor failure. Check Fans & Filters

Error Message Table
ASSOCIATED
DIAGNOSTICS
Heater startup Either: Do the following: N/A
error. Heaters
shut down. n The IMMULITE q Turn the IMMULITE off to
components have not reset the heater timers.
reached operating
q Turn the IMMULITE on.
temperature, even
though it has been 60 q Check the temperature
minutes since start-up. after 45 minutes (by
choosing System Status
n The power to the
and Temperature and
instrument was
Dark Counts from the
interrupted.
Primary screen).
Notes:
The IMMULITE
software does not need
to be loaded before the
system warms-up.
Once the IMMULITE
has reached operating
temperature, it should
be left on.
High and Low Different high and low Re-run the Adjustors using the N/A
Adjustor Test Adjustor Test Codes. (i.e. correct Adjustor definition.
Codes don’t An Adjustor is defined as
match
TSH and the high = TSH, but
the low = T4.)
High [Low] After dropping the high or Evaluate the cps of the PIPETTOR
Adjustor’s CVs low Adjustor replicate, which replicates:
between contributes to imprecision the
replicates are q If the CVs are very high
most, the CVs are still too
> than nn%. (50% or more), call
Adjust aborted. high.
Technical Services.
Note: This error can only be
q If the CVs are not high, re-
encountered only
run the Adjustor which
during the adjustment
caused the adjustment to
process.
fail, ensuring there are no
bubbles on the surface of -PROBANGL
either the sample or the -PIPXPOS
reagent.
-PROBTST
Note: Another sample cup
must be identified as an
Adjustor and followed
by four Test Units.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Illegal Occurs while calculating an Get CPS’s N/A
function call illegal math operation.
during Calc. See Also: CALC ERROR
test testCode
Illegal An invalid or 0 cps, caused Get CPS’s N/A
function call by either:
during Curve See Also: CALC ERROR
Adjust test n invalid parameters or kit
testCode Kit barcodes
Lot nn
n mechanical problems
“in Progress or The auto-number feature was Operator should not try to auto- N/A
resulted, selected, in the LIS Data number records that are closed
skipping.” Management screen, for or are in progress.
records already in progress or
resulted.
Insufficient Refer to the explanation for Refer to the solution for the N/A
sample the error message: No error message: No Sample
Sample Pipetted Pipetted Sample #nn
Sample #nn testCode testCode
Insuf. Reagent Either: Do the following: REAGENT
Pip. CAROUSEL/
n not enough reagent is q Ensure there is sufficient
PIPETTOR
available to complete the reagent available to
test complete all tests.
n a level-sense error was q Ensure there are no
encountered bubbles on the surface of
the sample and reagent.
n a Test Unit and Reagent
Wedge were mismatched q Replace the incorrect kit
component.
Invalid LIS ID LIS error message which Do the following: N/A
occurs when the Sender ID or
q From the Start-up menu,
Receiver ID is incorrect.
choose LIS PARAMS.
q Check that the Receiver
ID matches the LIS Sender -PROBANGL
ID and that the Sender ID -PIPXPOS
matches the LIS Receiver
ID. -PROBTST
Invalid LIS LIS error message which Do the following: N/A
Password occurs when the Header
q From the Start-up menu,
Message Password is
choose LIS PARAMS.
incorrect.
q Check that the Header
Message Password field
shows the same Header
Message Password used by
the LIS.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Kit not Found The kit parameters were Enter the kit barcodes (using N/A
testCode Kit overwritten with those of the laser scanner), and re-run
Lot nn. Curve another kit after pipetting. the adjustment.
Adjust aborted.
Note: Do not delete a kit
which is currently
running.
Less than 4 Refer to the explanation Refer to the solution below for N/A
replicates. below for: Less than 4 the error message: Less
Adjust aborted. replicates, or than 4 replicates, or
Adjustor results Adjustor results for
for all levels are all levels are not
not yet available. yet available.
Less than 4 Either: Depending on the cause, either: N/A
replicates, or
Adjustor n A record for one of the n Re-run the Adjustor.
results for all Adjustor replicates was
levels are not n Re-run the Adjustor which
deleted because of a
yet available was short the required
pipetting error.
number of replicates.
n An insufficient number
Note: This sample cup must
of replicates was loaded.
be re-identified and
followed by four Test
Units.
Level Sense The IMMULITE has not REAGENT
Error level-sensed either the CAROUSEL
reagent or the sample.
PIPETTOR
Note: If five Level
Sense errors occur,
the IMMULITE goes
into AutoPAUSE. -LEVSENSR-FSE
The error messages
associated with the -LEVSENSS-FSE
sample cup number -LEVFALSE
are recorded in the
Error Log. -PROBANGL
-PROBTST
-PIPXPOS
LIS Sent an Sender ID incorrect. Enter correct Sender ID in LIS N/A
INVALID ID of PARAMS. Check with LIS
NULL, record provider for correct ID.
not saved

Error Message Table
ASSOCIATED
DIAGNOSTICS
LIS Timeout The LIS is not responding to Re-send the results to the LIS. N/A
the IMMULITE. This can be
caused by:
q cable problem
q hardware problem
q bug in the LIS software
Load Chain Appears on the IMMULITE Look for source of the error LOAD PLATFORM
Error. Display Panel if an error is condition (i.e. a sample cup
detected and the IMMULITE incorrectly seated in the sample
is able to correct itself. cup holder or a crushed Test
Unit)
cannot correct the Remove vanity panel and check
error, the instrument for loose or popped baffles.
automatically shuts
Check for deformed test units
down the pipetting -LCHAIN
(front end) operation
and a message -EMPTYTUB
indicates this has
occurred. (The
instrument will
continue to process
the tests in progress.)
Low and High A Test Unit lot matches two Remove the Reagent Wedge N/A
Adjustor different Reagent Wedge which should not be used for
reagent lots lots. (i.e. Two Reagent the adjustment and re-run both
don’t match
Wedge lots are loaded. The Adjustors with only one reagent
first Reagent Wedge is used lot loaded on the instrument.
for the low Adjustor
replicates, but there is not
enough reagent for the high
Adjustor replicates, so the
second Reagent Wedge lot is
used.)
Low and High Two kit lots share the same Re-run the Adjustors using the N/A
Adjustor Test Reagent Wedge lot number correct Test Units (from the kit
lots don't but have different Test Unit which is being adjusted).
match
lots; therefore, the low and
high Adjustor replicates are
run with different Test Unit
lots.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Low cps sample The counts for a result are Ensure that: PIPETTOR
xx [test code] less than 15,000.
q there is sufficient reagent
(sample) available to
complete all tests
q there are no bubbles on the
surface of the liquid
q the syringe thumbscrew is -PROBANGL
tight
-PROBETST
Re-run the test for the record
which has the low cps. -PIPXPOS
Check Test units on exit chute. -SOLE1W
-SOLE2S
-WASHSPD
Lum. Chain and There is a Luminometer Look for the source of the jam. LUMINOMETER
Atten. Shut chain jam. Since this is a fatal error, the
Down. IMMULITE will stop. -ATTURN
-LUMCHN
-EMPTYTUB
Lum. Chain Appears on the IMMULITE Check for Test Units (or other LUMINOMETER
Error. Display Panel if an error is obstructions, such as
detected and the IMMULITE Luminometer chain baffles)
is able to correct itself. which may interfere with the
chain movement.
cannot correct the Check test unit on exit ramp,
error, the instrument rotate counter-clockwise until it
automatically shuts comes out -LUMCHN
down and a message
Check for popped or loose -EMPTYTUB
indicates this has
baffles.
occurred.
Note: Repeat any tests which
were in progress.
Lum. Temp. High The temperature reading for The IMMULITE should correct LUMINOMETER
[Low] the Luminometer is above or itself.
Note: The error below the acceptable range.
Note: All results generated
message will during a high or low
read either temperature period will
High or Low. be flagged on the -TEMPS
printout.
If the component feels hot, turn
the instrument off immediately.
Check Motor/Heater LED’s

Error Message Table
ASSOCIATED
DIAGNOSTICS
Main Car. Error This message will appear on Do the following: MAIN CAROUSEL
the IMMULITE Display
q Stop the IMMULITE
Panel if the error corrects
(press ALARM MUTE
itself.
and GO).
Note: If the problem cannot q Log off the system.
be corrected, the
q Load and run the
instrument
CARBACK (or
automatically shuts
CARPOS) diagnostic
down and an error
program, then
message indicates this
EMPTYTUB
has occurred. This is
often caused by a q Press the black Prime
sample cup holder button on the syringe
jammed on the module to index the
carousel under the Incubation Carousel
drive gear. counterclockwise.
q Remove the Test Units
-CARBACK
from the carousel as they
become accessible in the -CARPOS
Load Chain / Carousel
-EMPTYTUB
intersection area.
q Remove the sample cup
holder from the carousel.
q Choose RUN IMMULITE
or START TURBO to
repeat the aborted tests.
Note: Remove the Test Units
from the Load Chain
(between the Barcode
Reader and the
carousel) before
restarting the tests.
Mechanical Either: Based on the cause, either:
error LOAD PLATFORM
encountered n This message appears in n Determine the cause of all
(pipetting) conjunction with bad barcode reads and -BCODE
numerous bad barcode correct if possible.
reads. -BCODETST
n Clean O-ring idlers
n A problem was -BCODESPD
Determine the source of the
encountered with the
pipettor interference and PIPETTOR
pipettor.
correct if possible. Do not use
the IMMULITE until this -PIPXPOS
problem is corrected.
-PROBANGL
-PROBTST

Error Message Table
ASSOCIATED
DIAGNOSTICS
Message The computer missed a The software automatically N/A
received out of message from the requests that the message be re-
sequence, Seq = IMMULITE. sent.
xx
OldSeq = yy
Message Too Usually indicates a bug in the Re-send the results to the LIS. N/A
Short LIS software; however, could
LIS mesg. too If the error continues to occur,
be caused by a bad message
short\bad frame call your LIS provider.
(due to line noise, etc.).
Negative Slope Sample cups were identified Re-run both levels of Adjustors, N/A
calculated! Are as low and high, but either pipetting each level into the
the Adjustor the levels dispensed into the correct sample cup holder.
levels
reversed? cups were in the reverse
order or only one level was
run for both samples.
nn days since The database has not been Either: N/A
your last backed-up in the last 7 or
backup n ignore this message
more days.
n back-up the system
Note: Execution speed is
greatly reduced.
No info on this The LIS has no information Check the LIS to verify that the N/A
# regarding the accession accession number has been
number sent in the query. assigned.
Non-Turbo kits Non-Turbo reagent wedges Either:
cannot be run have been loaded onto the
while in Turbo reagent carousel while in n Remove all Non-Turbo
Mode. Please Reagent Wedges and press
take all non- Turbo Mode.
GO to continue running in
turbo kits off Turbo mode.
the reagent
carousel. n Log off and Choose RUN
IMMULITE to run the
Non-Turbo kits.
No Patient A record required for LIS Re-send the test order to N/A
Record for communications is not found. IMMULITE.
Order
No place in Either: Based on the cause, either: N/A
database for
Test Code xx n The sample cup was n Repeat the tests,
result. identified as a control or identifying the control or
Adjustor after passing Adjustor to the software
the Barcode Reader. before the sample cup
passes the Barcode Reader.
n The date on the
computer is incorrect. n Check the computer’s date
and time (see Initializing
the Software on page 4-2).

Error Message Table
ASSOCIATED
DIAGNOSTICS
No Place in Either: Based on the cause, either: N/A
Database to Put
Tube, Displayed n The Barcode Reader n Ensure that all sample cups
as Bad. read a Test Unit that was are loaded ahead of the
not proceeded by a Test Units on the Load
sample cup. Platform.
n The operator logged off n Press ALARM MUTE
and on the computer and GO simultaneously,
while the Analyzer was log off (via the Primary
still operating. Screen) and re-run the
tests.
No Reagent for Either: Depending on the cause either: N/A
approaching
testCode Tube n A Reagent Wedge is n Replace the missing
Part [Reagent missing from the Reagent Wedge.
Part] Reagent Carousel tray.
Lot#[lot#] CAUTION: The Reagent
n The Reagent Wedge and Wedge must be replaced
Test Unit lot numbers within 5 minutes or this test
are mismatched. result is lost.
n Refer to the solution for
the error message:
Reagent part A
missing.
No Reagent for Indicates either: Depending on the cause either: N/A
testCode tube
at the Barcode n there is no Reagent n Add the correct Reagent
Reader Wedge on board Wedge and press GO to re-
matching the Test Unit read the Reagent Carousel.
just read at the Barcode
n Press PAUSE to ignore the
Reader
message and this test will
n the current Reagent not be pipetted.
Wedge has Zero
Tests Remaining. n Remove all incorrect
(The instrument will go sample cups and test units
into AutoPAUSE mode.) that need to be run in a
different mode (Turbo or
n Turbo and Non-Turbo Non-Turbo) and press GO.
kits are on board at the
same time.

Error Message Table
ASSOCIATED
DIAGNOSTICS
No Reagent for Indicates either: Depending on the cause either: N/A
testCode
tube(s) on the n After the Test Unit(s) n Add the correct Reagent
load chain passed the Barcode Wedge and press GO to re-
Reader, the Reagent read the Reagent Carousel,
Wedge for these tests or, press PAUSE to ignore
went to Zero Tests the message (this test will
Remaining. not be pipetted).
n The Reagent Wedge and n Refer to the solution for
Test Unit lot numbers the error message:
are mismatched. Reagent part A
missing.
n Turbo and Non-Turbo
kits are on board at the n Remove all incorrect
same time. sample cups and test units
that need to be run in a
Non-Turbo) and press GO.
No Reagent Either: Re-run the test for the record REAGENT
Pipetted Sample which was deleted, making sure CAROUSEL
#nn testCode n Not enough reagent is
there is enough:
left to continued testing.
q sample (above the required
Note: The error will be
dead volume)
recorded in the Error
Log and on the q reagent (above the 1 mL
printed report. For dead volume)
this Test Unit, the
q Check probe LEVFALSE
report will say:
Record Deleted
Pipetting LEVSENSR
Error. LEVSENSS
n It’s a hardware-related
error (as indicated on the
instrument Display
Panel) .

Error Message Table
ASSOCIATED
DIAGNOSTICS
No sample cup Either: If there was a bad barcode read: LOAD PLATFORM
for Test Unit
n a bad barcode read q Wipe the label with a lint-
occurred for the tube just free towel or wash the
before the Test Unit label with light detergent.
(which may or may not
q If the barcode is torn or
be a sample cup)
wrinkled, discard the Test
n there are more than five Unit or sample cup holder.
Test Units behind a
q Perform maintenance on
sample cup
the barcode drive wheel
n there is no sample cup in (see page 6-20).
front of the Test Unit
q Repeat the tests. BCODE
If there are more than five Test BCODEON
Units, place the correct number
of Test Units behind the sample BCODETST
cup and re-run the test. BCODSPD
If there is no sample cup in
front of the Test Unit, place a
sample cup in front of the Test
Unit and re-run the test.
No Sample No sample was pipetted If the error was due to REAGENT

Pipetted Sample because an error was insufficient sample, ensure CAROUSEL
#nn testCode detected. The error can be: there is adequate sample in the
sample cup and re-run the test.
n hardware-related
If it is a hardware error, remove
n due to insufficient
any obstructions and re-run the
sample
tests.
If any other messages
accompanies the No
Sample Pipetted
Sample #nn testCode
message, it is a hardware
problem. LEVFALSE
Note: The error will be LEVSENSR
recorded in the Error LEVCRASH
Log and on the
printed report. For
this Test Unit, the
printed report will
say: Record
Deleted
Pipetting
Error.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Overflow Error A variable was set equal to a Note the exact overflow error N/A
during Adjust very large number. message.
test testCode
Kit Lot nn Note: This error is
infrequent when the
master curve
parameters are correct
and the IMMULITE
is running properly.
Overflow error Either: Check test units on exit ramp. N/A
during
calculation q A variable was set to a
test testCode very large number.
q A hardware error
occurred.
q The RS232 cable is loose
or disconnected.
Note: This is an infrequent
error when the master
curve parameters are
correct and the
IMMULITE is
running properly.
Pause mode; 5 The instrument will go into Check if each error was due to REAGENT
Level Sense AutoPAUSE mode if the insufficient volume for reagent CAROUSEL
Errors following errors occur 5 or sample.
Encountered
times within a run:
q Insuf. Reagent LEVSENSR
Pip.
LEVFALSE
q Not enough
sample error LEVCRASH
PC IMMULITE Communication between the q Check cable connections N/A
COMM FAILURE PC and the IMMULITE has between the IMMULITE
Check you cable been interrupted. and the PC.
connection now!
q Reset power on both the
Resuming normal PC and the IMMULITE
operation in 15 and select RUN
seconds. IMMULITE or START
TURBO from the start-up
menu.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Reagent Home This message appears on the Ensure the Reagent Carousel is REAGENT
Error IMMULITE Display Panel if seated properly and that CAROUSEL
the error corrects itself. nothing is blocking the sensor
beneath the carousel tray.
Note: If the problem cannot
be corrected, the front
end of the instrument
automatically shuts
down and an error REAGENTH
message indicates this REAGENTP
has occurred. Any
tests in progress will RBCODE
continue to be
processed.
Reagent Level Probe level senses above the Check for cap on Reagent REAGENT
Sense Error. maximum height of liquid. Wedge or large bubble on top CAROUSEL
Are there Caps of reagent.
on the Reagent
Vials?
LEVSENSR
LEVSENSS
LEVFALSE
Reagent lot# The correct lot information Re-read the reagent barcodes. N/A
xmit error could not be transmitted to
the IMMULITE.
Reagent Either: Re-run the Adjustors and enter N/A
pipetted does the correct kit.
not match kit. n Different Reagent
Adjust aborted. Wedge lots were Note: Be sure to use the
pipetted throughout the correct kit components.
two Adjustor levels.
n The kit needing
adjustment does not
correspond to the Test
Units and Reagent
Wedge used.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Reagent part A Either: If the Test Unit and Reagent REAGENT
missing Wedge lots are mismatched: CAROUSEL
n The Test Unit and
Reagent Wedge lots are q Check the Reagent Status
mismatched. A or Kit Entry screen for kit
mismatched lot occurs component lot numbers.
when the Test Units and q Confirm that the actual lot
Reagent Wedge numbers of Test Units
currently on-board are agree with the Reagent
not from the same kit lot. Wedge on-board.
Note: Pause is q Change either the Reagent
automatically Wedge or the Test Units,
initiated. as needed.
Note: Mismatched Test Units
n The Reagent Wedge has
appear as white circles
not been placed in the
on the Primary screen.
Reagent Carousel Tray.
Depending on the error
n The Reagent barcodes condition, these Test
have not been read after Units may be carried
the kit barcodes were around the Incubation
scanned into the Kit Carousel and sent to the
Entry screen. sample collection tray;
or, they may be shuttled
n Turbo and Non-Turbo
directly to the sample
kits are on board at the
collection tray.
same time.
Otherwise, do the following
(based on the cause):
n Place the Reagent Wedge
in the Reagent Carousel
Tray.
n Re-read the reagent
barcodes.
n Remove all incorrect
sample cups and test units
that need to be run in a
Non-Turbo) and press GO.
Reagent Pos. Refer to the explanation for Refer to the solution for the REAGENT
Error the error message: error message: Reagent CAROUSEL
Reagent Carousel Carousel Home Error.
Home Error.
RBCODE
REAGENTH
REAGENTP

Error Message Table
ASSOCIATED
DIAGNOSTICS
Reagent Temp The Reagent Carousel If just powering on the system, REAGENT
High temperature is above 22° C. you must wait 45 minutes for CAROUSEL
the analyzer to reach optimal
temperatures.
Check Motor/Heater LED’s TEMPS
Record Deleted Either: If there was insufficient sample, REAGENT

[No Sample] or do the following: CAROUSEL
[No Reagent] n The records were deleted
Pipetted because of insufficient q Check the printout or the
sample or reagent. Error Log for error
Note: This message
messages.
prints on the n The Reagent Wedge
report. went to Zero Tests Note: The Test Unit will
Remaining after the be in the sample
Test Units were read by collection tray.
the Barcode Reader and
q Re-run the test (Re-loading
the Reagent Wedge was
the reagent and sample if
not replaced before the
necessary.)
Test Units reached the LEVSENSR
carousel. For the other two causes listed,
LEVSENSS
re-run the assays.
n The second Reagent
Wedge for a sequential LEVFALSE
assay was missing or
went to Zero Tests
Remaining and the
Reagent Wedge was not
replaced in time to
complete the second step
of the assay.
Sample cup # A communication error N/A
mismatch occurred between the
Call Tech IMMULITE and the
Services
software.
Shut-Car Error This message appears on the Look for the cause of the jam LUMINOMETER
IMMULITE Display Panel if (Test Units, a bent shuttle flag,
an error is detected and the or a baffle that popped off the
IMMULITE is able to correct Luminometer chain).
itself.
Note: If the problem cannot
be corrected, the CARBACK
instrument
automatically shuts SHUTLOAD
down and an error SHUTSPIN
message indicates this
has occurred. SHUTTLE
LUMCHN

Error Message Table
ASSOCIATED
DIAGNOSTICS
Shut-Pos. Error Refer to the explanation Refer to the solution above for LUMINOMETER
above for the error message: the error message: Shut
Shut-Car. Error. Car. Error.
CARBACK
SHUTLOAD
SHUTSPIN
SHUTTLE
LUMCHN
Shuttle\Spinner This is a fatal error. The q Check for anything that LUMINOMETER
\ instrument cannot function would interfere with the
Pumps Shut Down and automatically shuts shuttle operation (i.e. bent
down. shuttle flag).
Note: All tests currently in q Repeat all tests which were CARBACK
progress are lost. in progress.
SHUTLOAD
SHUTSPIN
SHUTTLE
LUMCHN
Steps Left The IMMULITE sent an N/A
Overflow invalid value for calculating
the amount of reagent
remaining.
Substrate Substrate Heater did not Check cable connection behind LUMINOMETER
Heater failure reach operating temp (37° C) substrate heater.
in allowed time.
Substrate Low Level of substrate in Replace substrate bottle and LUMINOMETER
reservoir has dropped below press the gray button on
fill-line. substrate reservoir to fill the
reservoir to the fill-line.

Error Message Table
ASSOCIATED
DIAGNOSTICS
Syringe A [B] A movement error in the Note: This message remains SYRINGE
Error Corrected large syringe (A) or the small on the Display Panel
Note: The error syringe (B) was detected. until it is replaced by
message reads The message will appear on another message.
A or B. the IMMULITE Display
Check to see if a test result was
Panel if the IMMULITE was
affected: the Test Unit will
able to correct itself.
appear as a white circle on the
Note: If the error was not Primary screen and a Record
correctable, the Deleted, Pipetting
Error appears on the results PRIME
instrument
automatically shuts printout. APRIME
down the front end. Remove syringes and run
An error message BPRIME
indicates this has PRIME
occurred.
APRIME
BPRIME
Syringe ACK Either: If GO was pressed less than SYRINGE
error one minute after Start-up, do
n GO was pressed less
the following:
than one minute after
Start-up. The small q Turn the IMMULITE
pipettor syringes then power off for a minute,
fail to acknowledge then on again.
commands. q Wait for the syringes to
Note: The Test Unit move to the top of the PRIME
appears on the plunger and select RUN
APRIME
screen as a white IMMULITE or START
circle. TURBO from the Start-up BPRIME
menu.
n A hardware failure If a hardware failure occurred,
occurred. the system should correct itself.
Temperature The temperature controller CAUTION: Do not run the N/A
controller failed. IMMULITE until the
failure instrument is serviced.
TEMPS
Temperature The temperature controller Do not run the IMMULITE N/A

controller not has failed. until the instrument is serviced
operating
properly
TEMPS
Test Unit lots The Test Units being used do Re-run the Adjustors using the N/A
do not match not match the kit to be correct Test Units.
kit. Adjust adjusted.
aborted

Error Message Table
ASSOCIATED
DIAGNOSTICS
Tip Jam Error. Indicates either that: Depending on the cause either:
Are there caps
on the reagent n there is no sample n Check the sample volume.
vials? n caps were left on the If necessary, add more
reagent sample and re-run the tests.
n the probe is not n Remove cap(s) from the
positioning correctly reagent.
n Watch the pipettor to try
and determine the cause of
jam.
Turbo kits Turbo reagent wedges have Either:

cannot be run been loaded onto the reagent
while in Normal carousel while in Normal n Remove all Turbo Reagent
Mode. Please Wedges and press GO to
take all turbo Mode.
continue running in
kits off the Normal mode.
reagent
carousel. n Log off and Choose
START TURBO to run
the Turbo kits.
Valve A [B] A problem with the valve on See Front End Shut
Error the large (or small) syringe Down error message.
Note: A or B appears, was detected. If the
depending on IMMULITE cannot correct
the situation. the error, the front end will
shut down.
Note: The tests in progress
will be completed.
Warning: Part B A sequential assay Reagent Replace the missing part B
reagent Wedge is missing. reagent and press GO to read
missing. the reagents.
Hit PAUSE to
ignore or GO to
read reags.

Error Message Table
ASSOCIATED
DIAGNOSTICS
X Home Error. Something has interfered Do the following:
Note: This message with the probe movement or q Determine if anything (e.g.
appears on the a hardware error occurred. If
probe tubing) is interfering
IMMULITE the system cannot correct
with the pipettor
Display Panel itself, the instrument movements.
and in the daily automatically shuts down the
front end (pipetting and Load q Once the Test Units in
Error Log. process are finished,
Chain indexing). An error
message indicates this correct the problem and
occurred. restart the IMMULITE.
Note: The instrument will

continue to process
tests currently in
progress.
X Pos. Error Refer to the explanation for Refer to the solution for the
Note: Appears on the the error message: X Home error message: X Home
Error Error
IMMULITE
Display Panel
and in the daily
Error Log.
Z Home Error Refer to the explanation for Refer to the solution for the
Note: Appears on the the error message: X Home error message: X Home
Error Error
IMMULITE
Display Panel
and in the daily
Error Log.

Chapter 5. Mechanical Modules
5.1 System Overview and Associated Diagnostics
Luminometer & Shuttle: Water & Substrate Pumps:

Syringe Pump Assembly:
attent4 dissub
aprime (5000µl) diswat
emptytub
bprime (250 µl) sole1w
lumchn
prime sole2s
shutload
v1 test
shutspin
v2 test
shuttle
v4 test
washspd
schange
Reagent Carousel and

Reagent Carousel: Pipettor: Load Platform:
reagenth levcrash bcodeon
Main Incubation
reagentp levfalse Carousel: bcodespd
rbcode (use PC) levsensr carback bcodetst (use PC)
levsenss emptytub emptytub
pipxpos lchain
probangl
probetst

Mechanical Modules
5.2 Diagnostics Description Chart
Main Diagnostic Programs
The following table describes the diagnostic programs in detail, including whether or not they
stop automatically, if another program (PC, WATER or GETDATAT- refer to Chapter 6.1
Ancillary programs, for use and description of each program) is required, and which module(s) /
component(s) the diagnostic applies to.
The programs are listed alphabetically as they appear on the Diagnostics screen.
IMPORTANT NOTE: Check that probe and shuttle are in home position prior to running
diagnostics.
Main Diagnostic Function and Procedure Auto Other Applies to which

Stop Program module(s) /
Required component(s)
APRIME
Used to isolate priming of "A" large syringe for diagnostic No No Syringe “A” Pump
evaluation. Also, useful when performing a large syringe tip Assembly
replacement.
ATTENT4 – For Field Service Use Only

This test is very useful for checking the volume consistency No getdatat Water and Substrate
of the water and substrate pumps and the PMT consistency Pumps, Luminometer,
of readings/results. Place 4 test units on the carousel and Attenuator, Shuttle
manually move them around to the shuttle, to where the first
test unit is one position before entering the shuttle.
Warning: Ensure the test units are properly positioned as

described to prevent substrate from dispensing directly onto
the Luminometer chain. When the program is enabled, the
test unit is indexed into the shuttle and moved to the wash
position. An initial spin cycle is performed, followed by four
washes with water. A shot of substrate is added and the test
unit is moved to the Luminometer entrance. Each tube is
read by the Photomultiplier Tube (PMT) for twelve one-
second counts in both attenuated and unattenuated modes.
The test units are eventually indexed to the exit ramp.
ATTENTM – For Field Service Use Only

Same function and procedure as ATTENT4 diagnostic Yes getdatat Water and Substrate
except with this test load 15 test units one position before Pumps, Luminometer,
entering the shuttle. The test will automatically stop after the Attenuator, Shuttle
15th test unit is read by the PMT in both attenuated and
unattenuated modes.

Diagnostics Description Chart

ATTURN
Use this program to visually check the PMT attenuator disk No No PMT Attenuator Disk
motion and to verify sensor operation. The test cycles the
attenuator disk to the home position, attenuated position and
the unattenuated position. This can be monitored by
watching the position of the single sensor notch found on the
right side of the Luminometer cover above the PMT. The
single sensor notch points to a 9:00 position at home, 5:00 in
the attenuated position and 1:00 in the unattenuated position.
BCODE
Verifies proper functionality of the sample/assay barcode No PC Sample/Test Unit Barcode
reader. Place as many test units or sample cups as desired Reader
onto the load platform. A test unit/sample cup is read once
every two seconds, then the next test unit is indexed in front
of the barcode reader. Verify proper results on the "PC"
screen.
BCODEON
This test turns on the sample/test unit barcode reader motor. No No Sample/Test Unit Barcode
It can be toggled on and off by pressing the GO button on Reader Motor
the display panel. It verifies operation and is used for
cleaning the barcode reader drive wheel o-ring.
BCODESPD
This program is used to observe and/or adjust the motor No No Sample/Test Unit Barcode
speed of the sample/assay barcode reader. Load at least four Reader
test units/sample cups onto the load platform. Run the
program and observe the motor speed. It should be between
750 to 790 ms/rev for test units and 730-770 for sample
cups. Press the pause button to advance to the next test unit.
Each position should not be more than 40 ms/rev of each
other.
BCODETST
Verifies proper functionality of the sample/assay barcode No PC Sample/Test Unit Barcode
reader. Place as many test units as desired onto the load Reader
platform. Each test unit is read 25 times, then the next test
unit is indexed in front of the barcode reader. Verify proper
results on the "PC" screen and on the printer.

Mechanical Modules

BKGNDCNT
This program provides the current background counts for the No getdatat PMT
instrument’s PMT. It will alternate moving the attenuator
between the attenuated and unattenuated position. While at
each position, a set of 12 one second background counts are
taken. The getdatat program provides the actual raw
background counts.
BPRIME
Used to isolate priming of "B" small syringe for diagnostic No No Syringe “B” Pump
evaluation. Also, useful when performing a small syringe tip Assembly
replacement.
CARBACK
Useful for removing sample cups that have been mistakenly No No Incubator Carousel
indexed around the incubator carousel. This program moves
the carousel backwards in single index steps by pressing the
syringe prime button momentarily, or indexes continuously
by holding the prime button down. Homes the shuttle
CARCHECK
This program is used to judge the position of the main No No Incubator Carousel
incubator carousel in relation to the tube shuttle. It indexes
the carousel ring gear one position, moves the shuttle into the
space between the carousel baffles, pauses for one second,
moves the shuttle back to home and repeats.
CARPOS
This test checks the indexing of the main incubator carousel. No No Incubator Carousel
It indexes the carousel ring gear one position every second.
CARSHAKE
Checks the carousel shaking function. Momentarily Yes No Incubator Carousel
initializes, indexes the carousel one step, moves the shuttle in
the space between the baffles and shakes the carousel for a
few seconds.
CONFIG
No longer used. Refer to TABLE under System Config. n/a n/a n/a
menu for configuration table information.
DARKCNT
This program provides the current dark counts for the No getdatat PMT
instrument. It moves the attenuator to the home position,
then takes a set of twelve one second dark counts with the
PMT every fifteen seconds. The getdatat program provides
the actual raw dark counts.


DECON
Process used to introduce decontamination material into the No No Fluidics
fluidics of the Instrument. Refer to Maintenance Procedure
listed in section 7.4.2 for further details. This procedure
draws the decontamination fluid into both syringes, one at a
time and then into the water pump five times. This procedure
should be run for at least 15 minutes, followed by the
DECON1 procedure.
DECON1
This program must be used after the DECON procedure has Yes No Fluidics
been run. The purpose of this program is to flush out the
decontamination fluid and replace it with fresh fluids. Refer
to Maintenance Procedure listed in section 7.4.2 for further
details. This test will automatically stop after about twenty
minutes. The test will cycle through filling each syringe
twice then the water pump ten times.
DISSUB
Tests substrate pump dispensing volume. Place five test units Yes No Substrate Pump
on the load platform. Program indexes each test unit around
the incubation carousel then shuttles them to the substrate fill
position. A shot of substrate is added and the test unit moved
to the collection tray for evaluation.
DISWAT
Tests water pump-dispensing volume. Place five test units on Yes No Water Pump
the load platform. Program indexes each test unit around the
incubation carousel then shuttles them to the water fill
position. A shot of water is added and the test unit moved to
the collection tray for evaluation.
EMPTYTUB
This program is very useful to check the main driving motor No No Load chain, Main
movements of the instrument. Mainly this is used to evaluate Incubator Carousel,
proper coordination between interfacing driving motors of Shuttle, and Luminometer
the system. Tubes can be placed on the load platform and Chain
indexed through the entire system.
ERR36X
No longer used. n/a n/a n/a
HI316, HISTAT40
Not used n/a n/a n/a

Mechanical Modules

LCHAIN
This program is used to visually check the functionality and No No Load Chain
positioning of the load chain. It indexes the chain one
position every second.
LEVCRASH
Tests for the proper level sensing of the probe in each of the No No Pipettor
five sample pipetting positions. Manually, pipette a
minimum of 100 uL of liquid (PBS or probe wash- not
water) into five sample cups. Place the five sample cups into
the five pipetting positions. During the test, the pipettor will
level sense each sample cup starting in position five and then
progress cup by cup to position one. Any failures will trip
the tip jam sensor, which in turn will index the reagent
carousel one step.
LEVFALSE
Tests for the proper level sensing of the probe in the reagent, No No Pipettor
five sampling and assay dispense pipetting positions. This
test requires no sample cups to run. The pipettor will start at
the home position, move to the reagent position, level sense,
move to each of the pipetting positions, level sense and then
return to the home position to start again. The technician
must manually touch the probe over each position after the
probe makes it’s first pause on the way down. This is the
only time that level sensing is active. The technician’s timing
is crucial. A successful level sense over the reagent carousel
indexes the load chain one position. A successful level sense
over the five pipetting positions indexes the reagent carousel
one position. During the sequence the technician can also
jiggle the wires or cables to initiate intermittent problems.
LEVSENSR – Consult Field Service

Used in conjunction with LEVSENSS to check the auto No No Pipettor
calibration of the System Configs. LEVSNADJ dead volume
adjustment. This program should display a SL (steps left)
number between 8 and 12. –(If the program does not confirm
good SL numbers, repeat the System Configs. LEVSNADJ
test from the beginning, checking for proper manual
pipetting (pipette 1 ml into reagent wedge) of the minimum
dead volume in the test reagent vial.)


LEVSENSS – Consult Field Service

Used in conjunction with LEVSENSR to check the auto No No Pipettor
calibration of the System Configs. LEVSNADJ dead volume
adjustment. This program should display a SL number that is
reasonably close to the value for parameter 13 of the
CONFIG table.–(If the program does not confirm good SL
numbers, repeat the System Configs. LEVSNADJ test from
the beginning, checking for proper manual pipetting of
minimum dead volume (pipette 100µl into sample cup) in the
test sample cup.)
LO316CSP, LOSTAT40
LUMCHN
Checks the movement of the lumchain by indexing it one No No Lumchain
position every second.
CAUTION: Ensure shuttle is at far-left home position

before starting this test.
LUMTEST 4, LUMTEST 5,
LUMTEST 6, LUMTEST 9
Used in manufacturing only. n/a n/a n/a
MESG
This file contains the appropriate text messages that display n/a n/a n/a
on the IMMULITE display panel when running System
Configs. programs. If while running System Configs.
programs, the text messages on the IMMULITE display
panel seems to be incorrect, or if the IMMULITE display
panel is blank, exit the System Config. program and re-enter
answering “Y” to the prompt ”Download Diagnostic
Message Table?”
MESS317
This file contains the appropriate text messages that display n/a n/a n/a
on the IMMULITE display panel when running Main
Diagnostic (Download Files) programs. If while running
Main Diagnostic programs, the text messages on the
IMMULITE display panel seem to be incorrect, or if the
IMMULITE display panel is blank, download this program
to reset to the appropriate text messages for Main Diagnostic
programs.

Mechanical Modules

PIPXPOS
This program allows for visual inspection of the pipettor No No Pipettor
positioning. It moves the X pipettor to each position, starting
with home. At each position, it lowers the Z pipettor
momentarily. This test is used in conjunction with the Pip-X
Positioning Gauges. Refer to section 7.4.5 for more
information.
PMTCOUNT
Activates measurement readings by the PMT. No getdatat PMT
PRIME
This program primes the two syringes and the associated No No Syringe Pump Assembly
tubing. Priming removes excessive air bubbles and allows and Fluidics
for accurate dispensing of water and probe wash. It exercises
syringes A and B and solenoid valves 1,2 & 4.
PROBANGL
This program is used to evaluate the dispensing angle of the No No Probe
probe. The program positions the probe over the dump well
and then dispenses water. Check that the dispensing does not
exceed 7 to 10 degrees off center. Also, check for excess
spiraling of the stream. Subjectively, no more than 1 spiral
should occur per ¼ inch.
PROBETST
This program is used to evaluate the dispensing of the probe No No Probe
for any occlusion. It dispenses 3000uL at a maximum
velocity of 1000 uL/second into the home well. Look for any
excessive movement of the liquid up the probe shaft and/or
any splashing out of the side of the home well. During the
cycle, the probe lifts up and momentarily moves to the dump
well. Look for any dripping out of the probe at this moment.
Dripping indicates back pressure or occlusion inside the
probe or its associated tubing.
PROBWASH
This program runs a special enzyme cutting probe wash Yes No Probe
routine which is part of daily maintenance. A special probe
cleaning kit must be used in conjunction with this diagnostic.
Refer to the package insert instructions included with the kit
for more details.


RBCODE
This program tests the reagent carousel barcode reader. Load No PC Reagent Carousel Barcode
reagent wedges in the reagent carousel. The program moves Reader
the reagent carousel to the home position and then to each
position while reading reagent wedge barcodes. Use the
“PC” program to visually confirm the actual reagent wedge
reads.
REAGENTH
This program is used to check the reagent carousel home No No Reagent Carousel Home
position sensor. Check for proper position of the home Sensor
sensor by placing a wedge in the home position (position 1)
of the reagent carousel and running this program. The red
LED should shine an oval centered between the edge of the
wedge and the first barcode line when the carousel pauses at
home. Use the ALARM MUTE key to extend the pause at
home for a closer evaluation.
REAGENTP
This program is used to check the reagent carousel position No No Reagent Carousel Position
sensor in all twelve positions. Check for the proper position Sensor
of the individual position sensor using an empty reagent
carousel and running this diagnostic. Look directly straight
down through the individual notches found around the edge
of the carousel and check that one of the position sensor
heads is centered below each position notch. Verify all
wedge positions are centered over the sensor head below.
Use the ALARM MUTE key to extend the pause in each
position for a closer evaluation.
SCHANGE
This program is used when removing the syringes. It moves Yes No Syringe Module
both syringes down approximately halfway to permit the
removal of the syringes. After replacing the syringe tips,
press “GO’ to return the syringes to their home position.
SHUTLOAD
This program allows for the evaluation of the shuttle loading No No Shuttle
of the test unit into the spin position. Manually load a test
unit onto the carousel one position before entering the
shuttle. During this test, the test unit will be loaded into the
spin position. Inspect for proper actuation of the springs of
the shuttle, so that the test unit fits snugly pushed into the
spinner wheels. The test unit should sit on a straight angle
(without tilting). Press “GO” to have the program eject the
test unit for removal.

Mechanical Modules

SHUTSPIN
This program is used to evaluate the high-speed spinner Yes No Shuttle, High Speed
cycle. Manually load a test unit with 200 uL of liquid Spinner Motor
pipetted into it, onto the carousel one position before
entering the shuttle. During this test, the test unit will be
loaded into the spin position and the high-speed spin motor
will activate for 30 seconds. The test unit should slightly lift
up and the liquid should quickly clear from the bottom of the
tube. Watch that the bead moves off the bottom of the tube
and floats in air, while the tube is spinning. To check the
actual spinner speed, use the WASHSPD diagnostic.
SHUTTLE
This program is used to check the positioning of the shuttle. No No Shuttle
First, the shuttle is moved from the home position to a
neutral Luminometer position. Next the shuttle is moved to
the spinner wheels (which also is the water dispense
position), a brief “Sh Push” adjustment is applied, then the
shuttle is moved to the substrate dispense position. In some
instruments, if necessary a slight movement to the “Sh at
Lum” position is made to align the shuttle with the
Luminometer entrance. The cycle is then repeated.
SOLE1W
This program is used to check the dispensing volume and/or No No Water Pump
drawback adjustment of the water pump and/or to prime the
pump. Disconnect the water nozzle and hold a sample cup
under the water nozzle. Run the SOLE1W diagnostic to
dispense two shots. Use the “Alarm Mute” button to pause
and control the shots into the cup. The approximate level of
water should be at the fourth line of the sample cup (2 shots
at 200 ul/each = 400 ul). Confirm drawback is within
specification. Refer to the Drawback Specification Table at
the end of section 7.4.4. Adjust pump if necessary.


SOLE2S
This program is used to check the dispensing volume and/or No No Substrate Pump
drawback adjustment of the substrate pump, and/or to prime
the pump. Make sure the shuttle is in the full left position
so that substrate doesn’t accidentally leak onto the
Luminometer Chain. Disconnect the tubing on top of the
substrate heater and hold a sample cup under the substrate
tubing. Run the SOLE2S diagnostic to dispense two shots.
Use the “Alarm Mute” button to pause and control the shots
into the cup. The approximate level of substrate should be at
the fourth line of the sample cup (2 shots at 200 ul = 400 ul).
Confirm drawback is within specification. Refer to the
Drawback Specification Table at the end of section 7.4.4.
Adjust pump if necessary.
SPINCHK
This program allows for a quick visual check that the high- No No High Speed Spinner Motor
speed spinner motor is working. Manually load as many test
units as desired onto the carousel and manually rotate to one
position before entering the shuttle. During this test, the test
unit will be loaded into the spin position and the spinner
motor will turn on for one second.
SPINON
This program turns the high-speed spinner motor on or off, No No High Speed Spinner Motor
when pressing the “GO” button.
SUBSHEAT
This program is used to monitor the substrate heater. No No Substrate Heater
Remove the cover on the substrate heater. Using a DVM set
to DC volts, place the leads on the test points of the Heater
PCB. Run the program and monitor the starting (ambient)
temperature and final (heated) temperature. The DVM
reading is in direct correlation to the temperature. Multiply
the voltage measured by 100 and this will be the temperature
in Centigrade. The stabilized temperature should be 36.6 ± .6
o
C. When done measuring the temperature, be sure to exit the
program so that the substrate is not heated for a long period
of time.
TEMPS
Used to monitor instrument temperatures. The temperatures No getdatat or PC Temperature Sensors of:
are updated every thirty seconds and can be viewed via Reagent Carousel,
getdatat or PC. Use getdatat to print the temperatures. Luminometer, Main
Carousel, Ambient
NOTE: The PMT is not addressed in this diagnostic and
System, Ambient
therefore will read zero.
Electrical

Mechanical Modules

UPDOWNA
This program is very useful for checking the centering and No No Probe
rough depth of the probe in the test unit and the functions of
the pipettor Z home sensor and mid sensor. Load a test unit
on the load platform. Use EMPTYTUB diagnostic to index
the test unit to the main carousel dispense position. The
program will move the X pipettor to the test unit dispensing
position, then move the Z pipettor to the home sensor, down
to the mid sensor, then down the amount of error steps for
parameter 34 of the configuration table.
UPDOWNH
rough depth of the probe in the home well and the functions
of the pipettor Z home sensor and mid sensor. The program
will move the X pipettor to the home well position, then
move the Z pipettor to the home sensor, down to the mid
sensor, then down the amount of error steps for parameter 32
of the configuration table.
UPDOWNW
rough depth of the probe in the wash well and the functions
of the pipettor Z home sensor and mid sensor. The program
will move the X pipettor to the wash well position, then
move the Z pipettor to the home sensor, down to the mid
sensor, then down the amount of error steps for parameter 33
of the configuration table.
UNATTN10
Used in manufacturing only. n/a n/a n/a
V1 TEST
This program tests the functionality of Valve 1 (V1) of the No No Syringe Valve 1
syringe assembly. This program alternately dispenses water
through the probe and the wash well. The change in dispense
point is altered by the activation or deactivation of V1. If the
valve is not working at all the water will always dispense
from the probe. If the valve is stuck in the activated position,
the water will always come from the wash well. If one of the
two diaphragms in the valve is partially clogged, one port
will slowly drip while the other is dispensing.


V2TEST
syringe assembly. This program alternately dispenses water
through the probe and the probe wash container tubing. The
change in dispense point is altered by the activation or
deactivation of V2. If the valve is not working at all the
water will always dispense from the probe. If the valve is
stuck in the activated position, the water will always come
from the probe wash container tubing. If one of the two
diaphragms in the valve is partially clogged, one port will
slowly drip while the other is dispensing.
Another way of testing V2 is to suspend the probe wash

container above the instrument and check to see if a drop
begins to form on the end of the probe. If a drop has not
formed within 10 minutes, the valve is sealing properly.
V4TEST
syringe assembly. This program works exactly like V1TEST.
This program should alternately dispense water through the
probe and the wash well. The change in dispense point is
altered by the activation or deactivation of V4. If the valve is
not working at all the water will always dispense from the
probe. If the valve is stuck in the activated position, the
water will always come from the wash well. If one of the two
diaphragms in the valve is partially clogged, one port will
slowly drip while the other is dispensing. This program uses
V1 to direct the flow in a direction that can be differentiated
from the other.
VOL317
WASHSPD
This program tests and/or allows adjustment of the speed of Yes No High Speed Spinner
the high speed spinner motor. Follow prompts given on the
IMMULITE display screen. Adjust potentiometer R107 on
the DC Motor/Heater PCB to achieve 5500 RPM. Press
“GO’ to stop the program.
WATERTPM
This program is used whenever water or substrate Yes water Fluidics
contamination is suspected in the instrument. Refer to
section 7.4.1 “Maintenance Procedures” for further (suspected water
information on the use of this test. contamination in the
instrument)

Mechanical Modules

WATERTST
This program is used whenever water or substrate Yes water Fluidics
contamination is suspected. Test water from the water
supply. Refer to section 7.4.1 “Maintenance Procedures” for (suspected water
further information on the use of this test. contamination from the
water supply)
WTRTEM50
Used in manufacturing only n/a n/a n/a

Barcode Reader
5.3 Barcode Reader
Drive Wheel and

O-ring
Gearbox
Assembly
Motor

Mechanical Modules
FUNCTION: Sample cups and Test Units are moved from the load platform and pass the
barcode reader where they are rotated and the barcode is read and decoded. Based on the
barcode information, the sample cup or Test Unit is routed to the sample pipetting area or the
Main Incubation Carousel.
5.3.1 Problems/Troubleshooting:
Bad sample Barcode Reads
Associated Errors/Symptoms:
• “Bad Barcode read, last sample #N/A”: A sample cup or test unit was not able to be read at
the barcode reader…the last sample cup number that it was successfully able to read will be
displayed (rather than N/A). The sample cup or test unit will appear as a ghost on the
primary screen and will go directly to the sample collection tray, not the incubation carousel.
• “No sample cup for test unit”: This will occur for any remaining test units after a “bad
barcode read…” error, until another sample cup is successfully read. You can also get this
error in other situations, such as the barcode reader encountering a 6th test unit after a sample
cup.
Troubleshooting:
• Can finish run of test units on the Main Carousel and the Luminometer (be aware of 2
reagent assays in progress) or abort run if no other tests are in progress, then troubleshoot.
• Ask when the o-ring was last cleaned. Find out what they use to clean the o-ring (water,
alcohol-NO ALCOHOL!!). Also, ask if they wear powdered gloves; if yes, the o-ring may
require more frequent cleaning.
• Ask if bad reads are only on sample cups, test units or both.
• If sample cups only-Is it always the same sample cup holder numbers? Try cleaning cups
with lint free cloth dampened with water only (do not soak or labels will peel off). Check
label quality- are they torn, scratched, marked up, smudged or smeared?
• Get lot number of sample cup holders in use.
• Suggest ordering new sample cup(s) if necessary.
• If test units only- Is the problem only seen with one assay type or lot #, or one particular bag
of test units? Is this a new lot#?
• Observe cups/test units as they rotate in reader…it should only take 1-1.5 turns to read a
barcode. 4 revolutions or more could indicate a bad motor.

Barcode Reader
• Multiple bad barcodes reads and/or certain combinations can result in a sample cup getting
on the main carousel, eventually leading to a fatal front end shutdown. For instance, 8 bad
barcode reads in a row will place the 8th tube, whether a sample cup or test unit, on the
carousel. If someone has several instances of sample cups on the carousel, check error log
for frequency of bad barcode read errors and troubleshoot accordingly.
Diagnostics:
• Clean barcode reader o-ring using the BCODEON diagnostic. Be certain to use only water
(no alcohol- it dries the rubber, causing it to crack/spilt, requiring replacement), and a lint
free cloth (i.e. a Kimwipe- avoid gauze and cotton tipped applicators as they may get caught
in idler assembly). Using a lint free cloth and water, clean the 4 concave idler assembly
positions, including o-rings and spindles, as much as possible. Dry all areas thoroughly.
Check that the small idler o-rings are properly positioned and rotate freely…they may be
stuck due to crusted serum or trapped lint, or they got pushed out of position during cleaning.
• Use BCODESPD to check the speed of the barcode reader. Use 4 sample cup holders to
check all 4 idler positions (the display will say use test units…certain assay test units will
give fluctuating readings during this test, making it difficult to interpret. You CAN use test
units however, as long as they don’t initially generate a rev of about 300). Allow the cup to
be read for several cycles to let the speed stabilize and check that the readings are consistent
(within 10-20 of each other). Inconsistent speeds may mean worn idler o-rings, requiring a
service visit. Check the speed of the first position on the IMMULITE One display (rev time),
it should be 750-790 for test units and 730-770 for sample cup holders. If necessary, adjust
it. To adjust the speed, you will need a small flat head screwdriver…open the top cover on
the back of the instrument. On the second board from the left, towards the finger grips, you
will find two small plastic blocks, each with a small screw (potentiometers or “pots”). *If
you are having trouble explaining where the pots are, go into the tutorial, instrument
overview, Electronic Chassis section. Clicking on the “Motor/heater/valve control circuit
board” shows the entire board and points to the pots. Click on the troubleshooting box. The
“Top view of boards in chassis” gives a view of the general area, while “Close up of
Adjustment Potentiometers” provides a close up view. * If facing the instrument, the barcode
reader potentiometer is on the left-hand side (the right hand one is for the high speed
spinner). Turn the screw about a quarter turn at a time, allow speed to stabilize and take
readings. Press the Pause button to advance the next sample cup holder into place (you may
have to hold the button down-if it doesn’t respond keep trying). Allow speed to stabilize for
a few rotations then check the speed- it should be within 20-30 of first position. Don’t adjust
speed again. Hit Pause and check remaining 2 positions in same manner. If all 4 positions
vary greatly from each other the motor may be failing. If only some of the positions are off,
that area of the idler may be dirty, worn or damaged, and may need cleaning or replacement
by an FSE.

Mechanical Modules
• Run BCODETST. This diagnostic is useful either as part of your initial troubleshooting, or
as a confirmation that the problem has been corrected. Place several (at least 4, to test all
four idler positions) sample cups or test units on the load platform…the diagnostic will read
each cup or test unit 25 times. Once the program begins running, escape out of diagnostics,
exit to DOS and type PC. Answer the questions accordingly (when asked “cannot
communicate with IMMULITE, continue anyway” respond yes). The primary screen will be
displayed and the sample cup number or test unit type will appear on the main incubation
carousel each time it is read (25 times). If a bad barcode read is detected, a white ghost will
be displayed, indicating that there is still a problem. If only one position is giving bad reads,
again it may mean that particular idler position requires cleaning/o-ring replacement.
• Run BCODE. This diagnostic will test tubes similarly to BCODETST, but will test more
tubes in a shorter time (because it doesn’t read each tube 25 times). Use a combination of 20
test units and sample cups (try to use the ones that gave bad reads). As in BCODETST, once
the program begins to run escape out of diagnostics, exit to DOS and type PC. Answer the
questions accordingly (when asked “cannot communicate with IMMULITE, continue
anyway” respond yes). The primary screen will be displayed and the sample cup number or
test unit type will appear on the main incubation carousel as it is read. If a bad barcode read
is detected, a white ghost will be displayed, indicating that there is still a problem.

Load Platform
5.4 Load Platform
1
3
1. Load chain stepper motor

2. Sample/Test Unit Bar code Reader
3. Interface PCB
4. Bar code Reader DC motor
5. Star Gear
6. Load chain and chain path

Mechanical Modules
FUNCTION: This module transports sample cups and test units from the loading area to the
sample barcode reader, pipetting station, sample cups to the sample collection tray and test units
onto the main carousel.
Load Chain Problems:
• Load chain error: This error will appear on the IMMULITE One display panel if an error was
detected and self-corrected. If not correctable, the instrument will go into a front-end
shutdown, as described below.
• Front-end shutdown: The load chain and pipettor were stopped because of an error or jam in
the chain, pipettor or syringes, which was not self-correcting. Tests on the carousel and in
the Luminometer will continue to be processed (if possible…if the jam effected those
modules as well the samples will be lost), but new samples will not be pipetted.
Troubleshooting:
• Can finish run of test units on the main carousel and in the Luminometer (be aware of 2
reagent assays in progress) and then troubleshoot.
• Is the sample collection tray full?
• Look for an obstruction such as a deformed test unit or popped/loose baffles on the load
chain. If a baffle is popped, manually rotate the load chain (while in Idle, carefully grab a
baffle and pull the chain) so that the area missing the baffle is on one of the corners in the
platform. This gives the chain more support and stability for you to snap the baffle back on
the chain.
• Check that there are no sample cups stuck in the barcode idler assembly (if they order
disposable cups from another source, they may sit higher and could jam in the idler)
• Is the chain or platform sticky? Serum spilled?
• Is the star wheel at the entrance to the sample collection tray jammed, stiff, or mis-aligned?
Is there a sample cup or test unit tipped at the star wheel? Did the operator attempt to
remove a jammed sample cup from the star wheel?
• Other possible causes which require field service
• Motor or motor driver circuitry has failed
• The position sensor or related cabling has failed or the position sensor disk has dust
interference

Load Platform
Diagnostics:
• Run the diagnostic LCHAIN; the load chain should move freely. While running, check for
missing baffles (may need to remove vanity panel to locate missing baffle). If there is a
grinding sound, dispatch service (chain may be stiff from spilled serum and need
replacement).

Mechanical Modules
5.5 Luminometer
1. Stepper motor for the shuttle 2. Luminometer Chain Motor

3. Attenuator Motor 4. Photomultiplier Tube (PMT)
5. Shuttle assembly 6. Interface PCB
7. Luminometer chain 8. Attenuator assembly
9. High speed brushless DC motor 10. High speed spinner platform
FUNCTION: The Luminometer houses the Photomultiplier Tube (PMT) and the Luminometer
Chain. It maintains an incubation temperature of 37°C. Each test unit that passes through the
Luminometer is incubated for 10 minutes after the addition of substrate. After the incubation,
twelve 1-second readings are done and the high and low are discarded and the remaining 10 are
averaged. At high CPS the PMT is attenuated for increased photon counting range.
Problem #1: Luminometer chain not moving
• Lum. Chain and Atten. Shut Down – There is a Luminometer chain jam. Fatal error and
IMMULITE will stop.
• Lum. Chain Error – Appears if an error is detected and the IMMULITE is able to correct
itself.
• Shut – Car Error – This message appears on the IMMULITE Display Panel if an error is
detected and the IMMULITE is able to correct itself. Note: If the problem cannot be
corrected, the instrument shuts down and an error message indicates this has occurred. Look
for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that popped off the
Luminometer chain).
• Shut – Pos. Error – This message appears on the IMMULITE Display Panel if an error is
corrected, the instrument shuts down and an error message indicates this has occurred. Look
for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that popped off the
Luminometer chain).
Troubleshooting:
• A lumchain baffle has become dislodged and is interfering with the chain.
1. Put IMMULITE in Idle

Luminometer
2. Manually home shuttle to left

3. Manually move chain in counter clock-wise direction (back it up) to find where baffle has
come off
4. Move to left corner of gear, put baffle back on – See Load Platform section
• An assay tube has become jammed inside the Luminometer thus jamming the chain.
2. Place a test unit on the Luminometer Chain.
3. Manually move chain in counter clock-wise direction (back it up) until assay tube comes
into view
4. Remove assay tube
• The shuttle is mispositioned and interfering with the chain.

2. Manually home shuttle to left
• The chain tension has increased surpassing the torque capabilities of the motor.
Field Service required:
• The motor and/or motor drive circuitry has failed.

• The “LumcPos” parameters in the config table are incorrect
• The slotted sensor disk has become loose
Diagnostics:
• LUMCHN – Indexes the Luminometer chain one position every second. Takes 40 seconds
to complete a full rotation of the lum chain in this diagnostic. CAUTION: Ensure that the
shuttle is at far left home position before starting this test.

Mechanical Modules
Problem #2: PMT attenuator disc is not moving
• Possible CALC errors due to too high/low CPS counts
Troubleshooting:
• The attenuator parameters in the configuration table are incorrect.

• The belt or associated components have come loose.
• Associated bearings for the disk inside the cover have seized.
Problem #3: The Luminometer is not heating to temperature
See section on Temperatures.
Problem #4: The high-speed spinner is not moving
• CALC errors due to non-washing of bead

• Excess volume in test unit, washes are not completely removed after each spin
• Spinner error is posted
Troubleshooting:
• Check test units on exit ramp. Check the level and color of fluid covering the bead. The
fluid (representing substrate only at this point) should be clear, not yellow or cloudy and the
meniscus should just be touching the bead. If the level is too high and/or it is colored/cloudy,
the incubation mixture was not properly spun out, possibly due to a high-speed spinner
failure. Also, peel the test unit label and look at the level of fluid in the sump. The level in
the sump should be ½ to ¾ full, depending on the assay. If it is not, it could be due to a high-
speed spinner failure. Continue investigating the spinner as outlined below…if spinner is
functioning correctly, refer to the water and substrate solenoid section to troubleshoot water
and substrate dispense issues.

Luminometer
• The motor or motor drive circuitry has failed.

• The motor cable is not plugged in.
• The stainless steel motor coupling has loosened.
• The “O” rings are worn or missing allowing slippage
Diagnostics:
• SHUTSPIN – This program is used to evaluate the high-speed spinner cycle. Manually load
a test unit with 200 µL of liquid pipetted into it, onto the carousel one position before
entering the shuttle. During this test, the test unit will be loaded into the spin position and the
high-speed spin motor will activate for 30 seconds. The test unit should slightly lift up, the
liquid should quickly clear from the bottom of the tube and the bead should float in the air,
while the tube is spinning. To check the actual spinner speed, use the WASHSPD diagnostic.
• WASHSPD – This program tests and/or allows adjustment of the speed of the high speed
spinner motor. Follow prompts given on the IMMULITE display screen. Adjust
potentiometer R107 on the DC Motor/Heater PCB to achieve 5500RPM. Listen to spinner
and watch the speed of the tube. Press “GO” to stop the program.
Problem #5: Test units remaining on Luminometer Chain
Troubleshooting:
• User pushed “Alarm Mute” and “GO” after a front-end shutdown putting the instrument back
into “DPC IMMULITE IDLE Select Run IMMULITE to begin”. IMMULITE will shut down
immediately leaving all test units on the instrument.
• Continued power outage after the UPS has run out of power. IMMULITE will shut down
immediately leaving all test units on the instrument.
Diagnostics:
• LUMCHN – Indexes the Luminometer chain one position every second. CAUTION: Ensure
shuttle is at far-left home position before starting this test.
• EMPTYTUB – This program is very useful to check the main driving motor movements of
the instrument. Mainly this is used to evaluate proper coordination between interfacing
driving motors of the system. Any test units that are in the Luminometer will be pushed off
lum chain onto exit ramp. Tubes can be placed on the load platform and indexed through the
entire system.
Note: Before performing EMPTYTUB make sure shuttle is in home position (all the way to
the left) and there are no sample cups on the load chain.

Mechanical Modules
5.6 Main Carousel
The main areas of interest are:
1. Main Carousel Ring Gear Assembly

2. Stepper motor and Gear Assembly
3. Interface PCB
4. Heater pad

Main Carousel
FUNCTION: After the addition of sample and reagent, this module mixes and incubates assay
test units for 30 or 60 minutes until the shuttle moves them into the Luminometer for further
processing
Problem #1: Sample Cup on Carousel
• Fatal Main Carousel Error: This error will appear on the IMMULITE display panel if a
sample cup makes its way into the main carousel gear area, causing a jam which freezes the
carousel in its position.
• Front End Shutdown: This error will stop the movement of the load chain and pipetting of
further samples. The IMMULITE One will attempt to complete assays in progress on the
Luminometer Chain.
• Shuttle Spinner Pump Shutdown: This error sometimes occurs if the sample cup jam causes
the carousel positioning to become misaligned.
• Bad barcode read, last sample # N/A and No sample cup for test unit: Multiple bad barcode
reads can result in a sample cup on the main incubation carousel. Refer to section 4.2,
Barcode Reader, in this guide for additional information.
Troubleshooting:
• Find out where the test units are in process – allow samples to complete if the customer
chooses to do so.
• If you suspect a sample cup has gotten on the main carousel, ask operator to check that all
sample cup holders are accounted for. If a cup cannot be found in sample cup rack or in
sample collection tray it may be on the carousel. Examine carousel to find the sample cup. If
no sample cup is seen, it may be stuck in the gear area (at the 1 o’clock position). Press
ALARM MUTE and GO (Run will be lost) so that the IMMULITE display reads
“IMMULITE IS IDLE”; now all IMMULITE One parts should move freely.
• Check that the shuttle is in the “HOME” position inside the carousel at about 3 o’clock. You
may need to move the carousel just enough so that the shuttle can be pushed all the way to
the left out of the way of the carousel.
• Check error log for “bad barcode read” errors (and associated “no sample cup for test unit
errors”). Eight bad barcode reads in a row will place the 8th tube, whether a sample cup or
test unit on the carousel. If there is a high frequency of bad barcode reads in the error log,
refer to “Barcode Reader” section (section 4.2) of this guide.

Mechanical Modules
Diagnostics:
• LCHAIN- if sample cups are stuck in the barcode reader area, this diagnostic will move them
into the sample collection tray.
• CARBACK- Make sure the shuttle is in the “HOME” position as described above, follow the
prompts on the LED display. Press “Prime” (by the syringes) button to move the carousel
backwards. Rotate carousel until test units and/or sample cups are in pipetting area, where
they can manually be removed. The carousel should be emptied completely.
• EMPTYTUB- This diagnostic moves a test unit forward through the entire system. The load
chain, main carousel, shuttle and Luminometer Chain all advance in sequence. This
diagnostic is useful in removing test units from the system in the event of a shutdown while
samples are in process (although it is not necessary to remove the test units from the system
to re-start, it is RECOMMENDED to do so). It cannot be used to remove a sample cup from
the carousel as it moves the components forward and the incubation carousel cannot advance.
Also, if test units are closer to the pipetting area it will be quicker to use carback to remove
them.
Problem #2: Shuttle Spinner Pump Shutdown
• Shuttle Spinner Pump Shutdown

• Shut/Car Main Car/shut

Main Carousel
Troubleshooting:
• Prior to removal of test units, note the locations of the three carousel position markers with
respect to the main carousel position sensor. These are the black bullet shaped plastic pieces
screwed into the top of the carousel ring. They are 120° or 20 carousel positions apart.
Check with Field Services for the interpretation of findings, as this information helps to
distinguish between hardware and software related causes for this problem. If software is
determined to be possible root cause, a complete power down of the instrument may be
necessary after diagnostics is performed.
• Check for loose and/or popped baffles on the Luminometer Chain. If located, missing and/or
loose baffles can be popped back into place by moving the lum chain counterclockwise until
the affected area is at either gear turn, where the chain is anchored more steadily into place.
• Check for test units on the IMMULITE One floor, or mispositioned, and/or crushed test units
jamming the lum chain. These can also interfere with shuttle position checking.
Diagnostics:
• LCHAIN and CARBACK for test unit removal

• LUMCHAIN- for lum chain function
• EMPTYTUB- for shuttle and lum chain function
Problem #3:Carousel Sensor is not functioning/Ring Not Positioning Correctly
• Main Carousel Position error
Troubleshooting:
• Can occur if carousel interferes with shuttle operation in any of the aforementioned problems
• Generally , this is a service call, as the sensor is not seeing the holes in the carousel

Mechanical Modules
Problem #4:Load Chain Has Not Advanced Correctly
• Main Carousel Position error

• Any of the above mentioned errors
Troubleshooting:
• The load chain has not advanced correctly, an assay tube or sample cup holder is blocking
carousel movement. Remove the block using any of the methods discussed in the previous
text.
• Generally , this is a service call, as the position sensor and related items may be failing
Diagnostics:
• LCHAIN

Pipettor
5.7 Pipettor
Probe Assembly with cover
Probe Assembly with cover removed
1. Probe
2. Probe Fitting
3. Probe Tubing

Mechanical Modules
FUNCTION: Transfers liquid from reagent wedge and sample cup into test unit. The probe
consists of a stainless steel shaft with an inner core of Teflon tubing.
Problem #1: Level sensing errors
• Level sense errors (due to splashing or loose probe)

• 5 level sense errors in a run will put the system into AutoPause- check error log for
associated errors.
• Can also experience false triggering, with no error, but inappropriate results.
Troubleshooting:
• Check if probe is dispensing at an angle, using PROBANGL diagnostic. If not dispensing

straight it can cause splashing which can false trigger the probe.
• Check dispense quality of probe using PROBETST. If the probe is splashing while
washing/rinsing, water can get on guide arm; reagent carousel lid opening or wash station
rim and cause false triggering.
• Be certain no air is in the system…excessive air can cause splashing, as can an occlusion in
the probe. Prime the system manually or through the PRIME diagnostic.
For field service only:
• Check dead volume settings using LEVSENSS and LEVSENSR -if necessary to adjust the
settings, perform LEVSNADJ in System Configurations
• Check level sensing using LEVFALSE and LEVCRASH
Diagnostics:
• Run LEVFALSE to test for false level sensing. Put empty wedge on reagent carousel and a
sample cup at the farthest point on the load chain as visual markers. If the probe false level
senses in the reagent position the load chain advances. If it false triggers in any pipetting
position the reagent carousel indexes. You can also trigger the system to level sense by
touching the probe after its first pause on the way down. Wires and cables can also be
jiggled to trigger intermittent problems.

Pipettor
• Run LEVCRASH to check that probe is level sensing appropriately. Pipette at least 100 µl
of liquid (must be material that will detect a change in capacitance- i.e. PBS, probe wash,
reagent, sample) into 5 sample cups and put in position. Put an empty wedge in the reagent
carousel as a visual indicator and leave lid open. The probe will level sense each cup…if it
fails it will trip the tip jam sensor and index the reagent carousel.
• Run PROBANGL to test dispense angle of probe. Check probe as it is dispensing from
various angles (front, back, and sides). Probe should not be more than 7-10 degrees off
center. Also, unscrew the probe at the fitting at the top of the pipettor and twist as it
dispenses. If the stream spirals, the probe is bent. If the probe is bent or dispensing at an
angle it must be replaced.
• Run PROBETST to check for the dispense quality of the probe. Look for excessive splashing
on probe shaft or out of home well. Depth of probe in wash well may need adjustment…if
this is the case check with field service for confirmation/assistance.
• Run PRIME to check for and remove air from lines. The dispense will be turbulent if air is
in the system. Also, the 5000 µl syringe stops for about 1 second during dispense to switch
valves. At that moment water should come out in drips. If it doesn’t, it indicates the release
of back pressure from the fluidics, possibly due to a partially occluded probe or tubing, or the
presence of air.
• LEVSENSS will exercise the level sensor in the sampling positions. Put sample in a sample
cup in the first pipetting position. The diagnostic will repeatedly level sense in the cup and
display the steps left (SL) on the IMMULITE One display. The number should be
consistent. Also, confirm the probe is entering the cup, and is centered, when it level senses.
If the numbers are not consistent, check with field service for further instruction. It may be
necessary to run LEVSNADJ in System Configurations.
• LEVSENSR will test dead volume settings in the reagent positions. Place a wedge containing
1000 µl reagent in the 3:00 position on the carousel. The diagnostic will repeatedly level
sense in the wedge and display the steps left (SL) on the IMMULITE One display, which
should be between 8-12. Also, confirm the probe is entering the wedge when it level senses.
If the numbers are not appropriate, check with field service for further instruction…it may be
necessary to run LEVSNADJ in System Configurations.
• LEVSNADJ in System Configurations calibrates the sample and reagent dead volume.
CHECK WITH FIELD SERVICE PRIOR TO RUNNING THIS DIAGNOSTIC. Put 1 ml of
probe wash in a wedge in position 1 of the reagent carousel. Put 100 µl of probe wash in a
sample cup on the load platform (which will be indexed to the first sampling position). The
probe will level sense the reagent wedge and sample cup step by step…follow prompts on
the IMMULITE One display until “Calibration Successful” is displayed. Verify adjustment
by running LEVSENSR and LEVSENSS…if they are not run successfully, repeat
LEVSNADJ adjustment.

Mechanical Modules
Problem #2: Reagent level sense errors followed by “Are there caps on the reagent”
• Level sense errors

• “Are there caps on the reagents”
Troubleshooting:
• Occurs because system level sensed at >150 tests left. Check if:
• Caps are on the reagents (about 220 tests remaining calculated)
• There is a bubble on the mouth of the wedge (about 180 tests remaining calculated)
• Ask if a new reagent wedge was “topped off” with left over reagent.
• The wedge is mis-positioned (about 180 tests).
• The probe is loose or there is corrosion on the probe collar. Check the fitting at the top of the
probe block and tighten if needed.
• Water has splashed under the probe guide arm
• Probe block ground wire (from tip jam PCB) is disconnected.
• Sometimes occurs with the new wedge design and requires an adjustment of the probe
position in the reagent wedge (see below).
Diagnostics:
• Run PROBETST to check for splashing under guide arm.

• If associated with the new wedge design, do the following:
Find out if the probe is scraping the reagent wedge close to the operator or away from the
operator. If close to the operator=add step, away from operator=subtract a step
Steps for the adjustment:

1. Select “Diagnostics” then “System Configs”
2. Select “Y” to download diagnostic message table
3. Highlight “table” and press “enter”; select “enter” with “Run” highlighted
4. Press go on the IMMULITE to display the config table

Pipettor
5. Motor number=Q-quit, N-next (select N for Next)- at bottom of screen

6. Type #40 (sets horizontal positioning of probe at reagent wedge)
7. Error step=0<enter>
8. Extra=add one to the number or subtract one from the number located in the extra column
9. Then Q=quit
10. Answer Y (yes) to the question Save Config. Table?
11. Hit escape key to leave diagnostic menu
12. N=no to the question Restore Orig. Config. Table?
13. Y=yes to Download Main Message Table?
Problem #3: Pipettor positioning problems
• PIPX Home
• PIPZ Home
• PIPX Position
• Syringe overload errors (kinked tubing). Refer to Syringe Pump Assembly module for
further discussion on Syringe Overload errors.
• Errors will present on IMMULITE One display
• Will try to self-correct- if can’t, will result in front end shutdown. Finish processing any tests
in progress, log off the software and troubleshoot as described below.
Troubleshooting:
• Something interfered with probe movement. Check if probe tubing is too slack (causing it to
get caught on something, such as the lid or vanity panel) or too taut, not allowing it to reach
all positions.
• The tubing should flex over itself, without pinching, kinking or knotting, to allow probe to
reach all positions. Rotate pipettor to all positions while in idle and observe tubing
• Can result from operator error…operator may have tried opening lid or changing reagents
while probe was in motion.

Mechanical Modules
Problem #4: Precision Failure
• Poor sampling reproducibility

• Failed adjustments due to CV’s out of limits
Troubleshooting:
• Check that probe tubing has correct tension (see above)

• Check probe dispense angle and quality using PROBANGL and PROBETST respectively.
• Check X positioning of probe.
Diagnostics:
• PROBANGL (see above)

• PROBETST (see above)
• PIPXPOS moves X pipettor to each position and lowers. Check centering in each spot.
Problem #5: Blocked Probe
• Syringe Overload Error
Troubleshooting:
• Check dispense angle and quality of probe using PROBANGL and PROBETST respectively.
Diagnostics:
• Run PROBANGL to test dispense angle of probe. An occlusion can cause the probe to
dispense off-center (see above).
• Run PROBETST to check for the dispense quality of the probe. The probe will momentarily
move over dump well during cycle- see if probe is dripping, which can indicate an occlusion
in probe or tubing. If occluded, probe will need replacement.

Pipettor
• Run PRIME to check for an occlusion. The 5000 µl syringe stops for about 1 second during
dispense to switch valves. At that moment water should come out in drips. If it doesn’t, it
indicates the release of back pressure from the fluidics, possibly due to a partially occluded
probe or tubing, or the presence of air.
Problem #6: Blocked Probe
• Illegal function call
Troubleshooting:
• If this occurs on only a few samples, particularly competitive assays, it may mean that those
samples need to be diluted. If however, it is seen on several samples and several assay types
it may be a mechanical issue. Check that the probe not loose and tighten at the white ferrule
in the probe block if needed. Also, refer to syringe pump assembly section in this guide, as
the customer may be out of water or have loose syringes/thumbscrews.
Diagnostics:
• None
Problems Requiring Service:
Problem #1- Level Sensing:
• Intermittent short or open in flex cable ground wire on probe block is disconnected.
Problem #2- Probe not moving:
• Motor or motor drive circuitry has failed

• X Pipettor belt is broken
Problem #3- Pipettor X or Z not stopping at home or at position
• Sensor of position has failed

• Open in cable connecting sensor to microprocessor
• X pipettor belt worn or loose.

Mechanical Modules
5.8 Reagent Carousel
Reagent Barcode Reader

Reagent Tray

Reagent Carousel
FUNCTION: The reagent carousel provides a cooling chamber and barcode reader for the
reagent wedges. The chamber is cooled to 16 degrees C, but will only begin to cool after the
main carousel and Luminometer have exceeded 35 degrees C. The alarm will be activated at a
temperature of 22.0 degrees C or greater. The barcode scanner mounted at the side of the
chamber reads the reagent wedge barcodes as the carousel rotates. The chamber also includes a
reagent tray that the wedges clip into.
Problem #1: Bad barcode reads on the reagent wedges
1. Wedges may have condensation or other debris (e.g. spilled reagent or serum, powder from
gloves) on the barcode labels because they are being taken out of refrigerated temperature (2
to 8 degrees C) to the reagent chamber approximately 16 degrees C.
Troubleshooting
• Put the instrument into pause and wipe off the barcode labels on the wedges and reread the
carousel.
2. There may be a probe cleaning wedge left on the carousel. These wedges are not barcoded
and will appear as a ghost on the reagent display on primary screen.
Troubleshooting
• Put the instrument into pause and remove the unwanted wedge and reread the carousel.
3. Reagent wedge barcode labels may be damaged or have stray markings from dating
information by operator.
Troubleshooting
• If the wedge barcode truly is damaged, the instrument will probably never read it no matter
how many times the operator tries. The customer will need to try another wedge that does
not appear damaged and verify that it reads. The TSS should consider replacing the wedge.

Mechanical Modules
4. Barcode labels are mispositioned on reagent wedge.
Troubleshooting
• It may be possible for the operator to peel off the label and reposition it so it can be read.
They will need to align it on the wedge (down and to the right) so it falls within the window
of the reagent carousel barcode reader.
5. The reagent wedge is incorrectly placed in the reagent tray.
Troubleshooting
• Reposition the reagent wedge with the back notch in first and then the front snapping into the
tray. Be sure the wedge is between the tray dividers and not straddling them.
6. The notches in the reagent tray are bent. Visually check the reagent tray. Was it dropped?
Diagnostics
• REAGENTH – The instrument may not be able to find the home position consistently. The
instrument should consistently bring position 1 of the reagent carousel to the pipetting
position.
• REAGENTP – The instrument may not be able to consistently stop at all positions. The
reagent wedge should move all positions to the pipetting position and the spacing should be
the same for each position.
Troubleshooting
The customer can try to bend back the notch that appears to be bent. The reagent tray will need
to be replaced to prevent sensor wear.
7. The Reagent Carousel PCB is not functioning.

Reagent Carousel
Diagnostics
• RBCODE – Barcode reading is variable. This diagnostic is done with reagent wedges on
board and has to run through the ‘PC’ program. The reagent wedges present will all not be
consistently read and some will most likely show up as white ghosts.
Problem #2: Moisture in the Reagent Carousel
1. Condensation in the Reagent Carousel due to high humidity in the lab. (May also cause
intermittent bad barcode reads.)
Troubleshooting
• Wipe out reagent carousel with paper towel to get rid of excess moisture.
• If the problem if high humidity is persistent, it is possible to put the desiccants from the test
unit bags into the reagent carousel. This may help.
2. Back up of waste into reagent carousel.
Troubleshooting
• Check waste tubing for kinks.

• Empty waste bottle.
Problem #3: Temperature errors (see more information under section on Temperatures)
1. Bad TED (thermo electric device)

– temperature is too high

Mechanical Modules
Diagnostics
System Status / Temps /Dark Counts – Specification is 16.0 degrees C. Alarm will sound if >
22.0 degrees C. (See also section on Temperatures in this manual.)
• If temperature displayed is 22 to 30 degrees C, problem is most likely a bad TED.

- temperature is too low
Diagnostics
System Status / Temps/Dark Counts – Specification is 16.0 degrees C. Alarm will sound if >
If temperature displayed is < 15.0 degrees C (but not 11.6 degrees), the TED is stuck on and is
not turning off when the desired temperature is reached. The system will shutdown because of
the error. (There could also be a problem with the drive circuitry on the motor/heater PCB.)
Troubleshooting
• If the TED is determined to be bad, the system can be run by putting a small ice pack in with
the carousel or by pipetting the necessary tests and then returning the reagent wedges to the
refrigerator.
• A field service visit is required to replace the TED.
2. Short in Thermistor on the reagent carousel PCB

– Temperature is too high.
Diagnostics
System Status / Temps /Dark Counts - Specification is 16.0 degrees C. Alarm will sound if >
• If temperature displayed is in the 40’s degrees C, the temperature display is not correct and
the problem is the thermistor on the reagent carousel PCB.
– Temperature is too low.

Reagent Carousel
System Status / Temps /Dark Counts - Specification is 16.0 degrees C. Alarm will sound if >
• If temperature displayed is 11.6 degrees C., the thermistor is disconnected or electrically

open.
• A field service visit is required to address the short in the thermistor.

Mechanical Modules
5.9 Shuttle
Shuttle
High Speed Spinner

Luminometer Chain

Shuttle
FUNCTION: The purpose of the shuttle is to transfer the Test Unit from the Main Incubation
Carousel to the Wash/spin station and the Luminometer chain.
Problem #1: Shuttle is not moving
• Shut – Car Error – This message appears once on the IMMULITE Display Panel if an error is
corrected, the message is posted on the display immediately before the instrument goes into
idle. “Shuttle spinner pumps shutdown” will be printed and posted to the error log, as a
result of the shutdown. In this case the shuttle could not find its home position, possibly as a
result of a jam. Look for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that
popped off the Luminometer chain).
• Shut – Pos. Error – This message appears once on the IMMULITE Display Panel if an error
is detected and the IMMULITE is able to correct itself. Note: If the problem cannot be
result of the shutdown. In this case the shuttle could not find its position, possibly due to a
jam. Look for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that popped off
the Luminometer chain).
• Shuttle\Spinner\Pumps Shut Down – this is a fatal error. The instrument cannot function and
automatically shuts down. (Note: all tests currently in progress are lost)
• Carousel Shut Down – This message appears when the Main Carousel is disabled (i.e. when
a shuttle/carousel jam is detected)
Troubleshooting:
• The main carousel has mispositioned and is blocking shuttle movement. Move the Main
Carousel back and forth manually to enable movement of the shuttle to the home position to
the left.
• A lumchain baffle has become dislodged and is interfering with shuttle movement.
• Look for the cause of the jam (Test units, a bent shuttle flag, or a baffle that popped off the
Luminometer chain).
• The shuttle parameters in the configuration table are incorrect.

Mechanical Modules
• A sensor has failed or become dislodged

• A tube has fallen into the path of the shuttle and has broken the shuttle sensor flag
Diagnostics:
• SHUTLOAD – This program allows for the evaluation of the shuttle loading of the test unit
into the spin position. Manually load a test unit onto the carousel one position before
entering the shuttle. During this test, the test unit will be loaded into the spin position.
Inspect for proper actuation of the springs of the shuttle, so that the test unit fits snugly
pushed into the spinner wheels. The test unit should sit on the straight angle (without tilting).
Press “GO” to have the program eject the test unit for removal.
• SHUTTLE – This program is used to check the positioning of the shuttle. It moves the
shuttle to the Luminometer position, the high-speed spinner position and back to the home
position at the main carousel.
Problem #2: Shuttle is jammed against the main carousel
• Main Car. Error – appears if an error is detected and the IMMULITE is able to correct itself.
Note: If the problem can not be corrected, the instrument automatically shuts down and an
error message indicates this has occurred. This is often caused by a sample cup holder
jammed on the carousel under the drive gear.
• Shut – Car Error – This message appears once on the IMMULITE Display Panel if an error is
result of the shutdown. In this case the shuttle could not find its home position, possibly as a
result of a jam. Look for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that
popped off the Luminometer chain).
• Shut – Pos. Error - This message appears once on the IMMULITE Display Panel if an error
is detected and the IMMULITE is able to correct itself. Note: If the problem cannot be
result of the shutdown. In this case the shuttle could not find its position, possibly due to a
jam. Look for the cause of the jam (Test Units, a bent shuttle flag, or a baffle that popped off
the Luminometer chain).

Shuttle
Troubleshooting:
• If shuttle is jammed against the carousel, manually move the shuttle to the left (home
position). Main carousel may need to be moved slightly to disengage shuttle.
• If a sample cup is jammed on the main carousel press ALARM MUTE and GO. Log off the
system. Load and run the CARBACK diagnostic program. Press the Prime button on the
syringe module to index the Incubation Carousel counterclockwise. Remove test units and
sample cups, as they become accessible in the Load Chain/Carousel intersection area.
Diagnostics:
• SHUTTLE – this program is used to check the positioning of the shuttle. It moves the
shuttle to the Luminometer position, the high-speed spinner position and back to the home
position at the main carousel.

Mechanical Modules
5.10 Syringe Pumps
V1
V2 Prime button
V4
Hamilton
Syringe Pump
Prime Button
V1
V2
V4 DPC Syringe Pump

Syringe Pumps
FUNCTION:
A. 6\ULQJH/HIWODUJHV\ULQJH OSXPSVSUREHZDVKWKURXJKSUREHDQGZDVKZHOOVWDWLRQ
B. 6\ULQJH5LJKWVPDOOV\ULQJH OSUHFLVLRQV\ULQJHDVSLUDWHVDQGGHOLYHUVUHDJHQWVHUXP

sample, water [distilled from external water bottle] from sample cups or reagent wedges into
test unit
Problem #1: Syringe Overload Error:
• Kinked or crimped tubing

• Blocked probe
• Incorrect installation of syringe tips
• Power glitch or interruption
• Noisy pump (squeaky noise) when syringes prime
Troubleshooting:
• Fix kinked tubing

• Replace blocked probe
• Change syringe tips
• Power IMMULITE off and on. If error continues, need to have Field Service Engineer
replace module or logic board
• If syringes are squeaking, remove syringes and run PRIME with them removed. If noise
disappears, syringe(s) are probable cause…replace them. If noise continues, probably the
dilutor module itself.
• *For Hamilton Syringe assembly- If error continues it will be necessary to replace entire
syringe pump assembly- to verify that the assembly needs replacement; remove syringes and
press prime. If error repeats it will be necessary to replace the assembly

Mechanical Modules
Diagnostics:
• SCHANGE to remove syringe and/or change syringe tip
Problem #2: Left or Right Valve Inoperative:
• Power glitch or interruption

• Failure of dilutor module
Troubleshooting:
• Power IMMULITE off and on
Diagnostics:
• None
Problem #3: Bubbles in syringes or tubing
• Water & Probe Wash bottle empty; end of tubing not under liquid level
• Loose Fittings [Reseat all fittings]
• Poor syringe tip maintenance [replace syringe tips]
• Syringe tips may be off plunger and stuck in barrel
• Water and Probe Wash bottle fittings loosened or white plug missing from lids of Water &
Probe Wash bottles
• End of Line Filters [remove filter, if bubbles stop replace with new filters and prime for 10
minutes to saturate new filter]
• For older version Hamilton assembly reseat macro & micro valve blocks by pushing on
valves or release lever on bottom of each valve & push valve in & re-lock lever

Syringe Pumps
Troubleshooting:
• As stated above
Diagnostics:
SCHANGE- to replace syringe tips
Problem #4 Precision Failure
• Check if daily Probe Clean is run and if fresh solution is used daily.
• Bent or damaged probe
• Air in the tubing
• Kinked tubing
• Poor end of line filter maintenance
• Loose fittings on bottles, probe, valves [Reseat fittings]
• Check if Kloehn syringes [incorrect brand] were mistakenly installed on a Hamilton Dilutor
resulting in introduction of air into the dilutor
Troubleshooting:
• Run “probangl” diagnostic

• Run all valve tests [valve failure requires Field Service Engineer to replace valve]
Hold water and probe wash bottles above level of instrument while running valve tests and
look for drops from probe. If drops appear, valves are failing.
Valve #1 Testing
Run the V1TEST diagnostic. The water should alternately dispense from the "probe" and from
the wash well. Except for valve throw, the water should never move in the tubing when the water
is dispensing up from the bottom of the wash well. If water is moving down the probe when it
should not be, this can cause under-aspirating of reagent and/or sample. It can also cause fluid to
be drawn into the probe from the home well resulting in carryover.

Mechanical Modules
Valve #4 Testing
Run V4TEST diagnostic. The water should alternately dispense from the "probe" and from the
wash well. Except for valve throw, the water should never move in the tubing when the water is
dispensing up from the bottom of the wash well. If water is moving down the probe when it
should not be, this can cause under-aspirating of reagent and/or sample. It can also cause fluid to
be drawn into the probe from the home well resulting in carryover.
Valve #2 Testing
Run the V2TEST diagnostic. The water should alternately dispense from the "probe" and the
tubing that goes into the probe wash container (that has been removed from the wash container
and placed into a container or the wash station for this test). Follow instructions given on the
IMMULITE Display. Except for valve throw, the water should never move in the probe tubing
when the water is dispensing from the disconnected Probe Wash tubing.
• 5XQUHSOLFDWHVRIWKHORZDGMXVWRURQD OVDPSOHVL]HDVVD\LH+&*>H[SHFW&9¶V
less than 10%]
• Review CV% on adjustor replicates from several different assays with 5-10uL sample size.
Problem #5: Illegal function call
Troubleshooting:
• If this occurs on only a few samples, particularly competitive assays, it may mean that those
samples need to be diluted. If however, it is seen on several samples and several assay types
it may be a mechanical issue. Check water level in bottle and for loose syringes and/or
thumbscrews. Also, refer to pipettor section in this guide, as the probe may be loose.
Diagnostics:
• None

Temperatures
5.11 Temperatures
FUNCTIONS:
There are three areas of temperature control on the IMMULITE: the Luminometer and the
incubator carousel are heated, and the reagent carousel is cooled. Two other areas are monitored:
the ambient temperature of the electronics area and the test unit processing area.
Luminometer Temperature
• Specification: 36.9 to 37.1 degrees C

• Can take up to 45 minutes to reach this specification when the instrument is powered on.
• The alarm will be activated below 36.8 and above 37.2 degrees C.
Incubator Carousel Temperature
• Specification: 36.5 to 37.5 degrees C

• Takes approximately 15 minutes to reach this temperature when the instrument is powered
on.
• The alarm will be activated below 36.0 and above 38.0 degrees C.
Reagent Carousel Temperature
• Specifications: 16 degrees C.
• Takes approximately 15 minutes to reach this specification when the instrument is powered
up. Will not begin to cool until the Luminometer and incubator are above 35.0 degrees C.
• The alarm will be activated above 22.0 degrees C.
System Ambient Temperature
• This is the temperature of the instrument when the main cover is closed.
• The temperature at which an alarm will be activated is above 34.0 degrees C.

Mechanical Modules
Electrical Ambient Temperature
• This is the temperature of the area where the main PCBs are located.
• The temperature at which an alarm will be activated is 40.0 degrees C.
Viewing Temperatures
IMMULITE operating software, System Status, temps/dark counts:
• The latest temperature data sent to the PC from the IMMULITE will be displayed.
• New temperatures sent every 30 seconds. To update the screen, hit the space bar.
• Temperatures will not be sent to this screen until going through the daily start up and the
display indicates “DPC IMMULITE RUNNING”.
• The average temperature on this screen is the average of the last ten readings, therefore,
unless the instrument has been running for 5 minutes, there will be no data displayed. (Note:
On rare occasions, a ‘Delta Error’ may occur. This indicates that the IMMULITE software
has no temperature information or the temperature data is not current and a message is
needed from the instrument. Just press Esc and go to View Temperatures and Dark Counts
again.)
Temperature Controller Status Indicators
4 LED’s located on the Motor/Heater PCB in the back of the instrument. They are visible with
the cover lifted and standing just off center to the right of the gas struts.
From left to right (facing the instrument) in normal operation:
• L4 TED (cooler) – when cooling, the light is on. When desired temperature is reached, LED
is off.
• L3 Luminometer Heater – Light is steady at first to heat to 35 degrees C. Then as
temperature increases the ‘On’ time of the LED decreases until it reaches the desired
temperature of 37 degrees C. Once that temperature is attained, the ‘On/Off’ time is equal.
Blinks at a rate of 5 times/second.
• L2 Carousel Heater - Light is steady at first to heat to 35 degrees C. Then as temperature
increases the ‘On’ time of the LED decreases until it reaches the desired temperature of 37
degrees C. Once that temperature is attained, the ‘On/Off’ time is equal. Blinks at a rate of 5
times/second.

Temperatures
• L1 Time Hack – Blinks at a rate of once/second. This LED indicates that the temperature
control circuitry is functional. (Note: It must be blinking or other LED’s and displayed
temperatures are invalid.)
See attachment for status indications during various conditions.
If customer calls with temperatures out of specifications: see attached Temperature

Troubleshooting Guide.

Mechanical Modules
5.11.1 Temperature LEDs and how to decode them
On the Heater/ DC Motor PCB there are four LEDs (Light Emitting Diode) that indicate the
status of the Luminometer heater, incubator carousel heater, reagent carousel cooler and the
control microprocessor. The control microprocessor LED, called the time hack, indicates the
microprocessor is active. The other three LEDs indicate what the transistors which control the
heaters and cooler are being instructed to do, not necessarily what they are actually doing. For
example, if the source to drain junction is shorted on the transistor controlling the incubator
carousel, that temperature will quickly rise. Once the temperature rises above 39°C (for 10
minutes) the microprocessor will instruct the transistor to turn off and the incubator carousel
LED will indicate the same. Since the transistor is shorted, power is still being applied to the
heater. Therefore, the activity of the heater and cooler LEDs is a reflection of the reported
temperature of the device to be heated or cooled except if the microprocessor has chosen to
shutdown the heaters and/or cooler.
TEMPERATURE CONTROLLER STATUS LEDS
LED # L4 L3 L2 L1
Identity TED (Cooler) Luminometer Heater Carousel Heater Time Hack
LED "ON" - Temp is above - Lum temp is below - Car temp is below 35 - Microprocessor has
16.5 35 had a fatal error. The
status of all other LEDs
is invalid!
LED "OFF" - Temp is below - Lum temp is above - Car temp is above 39 - Microprocessor has
16.5 39 had a fatal error. The
- Heaters and cooler status of all other LEDs
- Cooler has shut - Heaters and cooler have shut down due to a is invalid!
down due to a heater have shut down due heater temp low error
or cooler temp error to a heater temp low
error
- Lum and/or main
carousel have not
reached 35
LED Blinking Cooler has shut - Heaters and cooler - Heaters and cooler - Microprocessor is
@ 1hz down due to cooler have shut down due have shut down due to functional
temp error to lum temp high car temp high error
error
LED Blinking N/A - Lum temp is above - Car temp is above 35 N/A
@ 5hz 35 DQGEHORZ and below 39
Note: The LEDs (L4 – L1) are in the above order when viewed from the front of the instrument.

Water and Substrate Pumps
5.12 Water and Substrate Pumps
MGM Injector Pump Cirrus Injector Pump

(can be found on instruments (can be found on instruments
up to serial # F1594) after serial # F1559)

Mechanical Modules
FUNCTION: These pumps automatically pump substrate and water into the test unit during the
spin/wash cycle. The solenoid pumps are interfaced with the motherboard #1.
DESCRIPTION: Facing the instrument: the solenoid pump is located on the right hand side,
behind the load platform, to the right of the substrate housing.
Problem #1: Air bubbles have appeared in the tubing
Associated Errors:
• CPS consistent with no substrate.
Troubleshooting:
• A fitting has loosened

• Water and substrate levels are low enough to allow air to enter the system
• System not primed if bubbles appear at beginning of run
Diagnostics:
• SOLE1W
• SOLE2S
Problem #2: No substrate being dispensed
Associated Errors:
• Imprecision in results
Troubleshooting:
• Substrate nozzle is clogged

• Substrate nozzle is empty
• The solenoid pump has failed
• The circuitry has failed

Diagnostics:
• SOLE2S= Dispenses one 200ul of substrate every second. Good for checking the volume
being dispensed and a quick prime of the pump. Prime the pump for several cycles. When
all air is removed, hold the nozzle tip over a sample cup and collect the volume from a single
dispense. Measure the amount with a pipette. It should be 200 ± 10 µl. If it is not, service
will be required. Can also dispense into a test unit to check that the bead is covered.
Problem #3: Substrate volume dispensed is incorrect
Associated Errors:
Troubleshooting:
• The substrate nozzle is partially clogged causing the substrate to dispense at an angle or miss
the test unit
• The calibration screw for the substrate solenoid pump has shifted position
Diagnostics:
being dispensed and a quick prime of the pump. Prime the pump for several cycles. When all
air is removed, hold the nozzle tip over a sample cup and collect the volume from a single
will be required. Can also dispense into test unit to check that bead is covered.
Problem #4: No water being dispensed
Associated Errors:

Mechanical Modules
Troubleshooting:
• Water container empty

• Fitting on the line has become very loose
• Place the water nozzle into a beaker of fresh, clean distilled water and run SOLE1W.
• Water solenoid pump has failed
• Circuitry has failed
Diagnostics:
• SOLE1W= Dispenses one 200ul of water every second. Good for checking the volume being
dispensed and a quick prime of the pump. Prime the pump for several cycles. When all air is
removed, hold the nozzle tip over a sample cup and collect the volume from a single
Problem #5: Water volume being dispensed is incorrect
Troubleshooting:
• Calibration screw for the water pump has shifted position

• The water supply bottle has become empty
Diagnostics:

Problem #6: Imprecision/inaccuracy
Troubleshooting:
• Could be due to incorrect amount of water or substrate dispensed. Check test units on exit
ramp. Check the level and color of fluid covering the bead. The fluid (representing substrate
only at this point) should be clear, not yellow or cloudy and the meniscus should just be
touching the bead. If the level is not correct, it could be due to a substrate dispense problem.
Also, peel the test unit label and look at the level of fluid in the sump. The level in the sump
should be ½ to ¾ full, depending on the assay. If it is not, it could be due to a water dispense
problem. Continue investigating the water and substrate dispense volumes, as outlined
below. If dispense volumes are correct, refer to the Luminometer section to troubleshoot
high-speed spinner problems.
Diagnostics:
being dispensed and a quick prime of the pump. Prime the pump for several cycles. When all
air is removed, hold the nozzle tip over a sample cup and collect the volume from a single
• DISSUB= Transports 5 test units form load chain, dispenses substrate into each test unit and
moves them to the sample collection tray. Check the level of each for consistency. Also,
check if there are any splatters on the side of the test unit. If the nozzle is not dispensing
straight down and some of the substrate is splattering on the side of the tube, it could cause
imprecision.
• DISWAT= Transports 5 test units form load chain, dispenses water into each test unit and
moves them to the sample collection tray. Check the level of each for consistency. Also,
check if there are any splatters on the side of the test unit…if the nozzle is not dispensing
straight down and some of the water is splattering on the side of the tube, it could cause
imprecision.

Mechanical Modules

Chapter 6. Hardware
6.1 Laser Scanner Symbologies
The following symbologies are enabled as default for the IMMULITE One Laser Scanner:
EAN/JAN (8 or 13) digit
UPC with 2 or 5 Digit Supplement disabled
Code 39
Code 128
The following symbologies can be enabled by scanning the appropriate code in the symbology
section of the PSC User’s Guide for the Handheld Laser Scanner:
Interleave 2 of 5
Standard 2 of 5
UPC A
UPC E
Code 93
Codabar
Code 11
MSI/Plessy

Hardware
6.2 Laser Scanner Programming
PSC Laser Scanner
To program the PSC Laser Scanner to be used with the IMMULITE, exit to DOS and perform
the following steps:
Note: When scanning the barcodes below, the yellow light on the back of the scanner will turn
on when the laser is on and the green light will turn on to indicate a successful scan. The scans in
steps 1 through 3 will also provide a low beep followed by a high chirp when successful. Steps 4
through 6 will provide a single low beep. Step 7 will provide a low beep for the first five scans
and a high chirp on the last scan.
The bar code labels shown below were generated through bar code software. Reproduction
through copying or faxing should not be performed.
1. Scan the “Wedge Mode Enable” barcode (Hex Equivalent is CE):
(Page 62 of old Bar Code manual, “REV.B”; page 46 of new Bar code manual, “REV.B-
2/97”)
2. Scan the “Reset to Default” barcode (Hex Equivalent is ZA):

(Page 63 of old Bar Code manual, “REV.B”; page 46 of new Bar Code manual, “REV.B-
2/97”)

Laser Scanner Programming
3. Scan the “PC-AT, PS/2 and 50/60/80” barcode (Hex Equivalent is CF):
(Page 62 of old Bar Code manual, “REV.B”; page 46 of new Bar Code manual, “REV.B-
2/97”)
4. Scan the “Enter Postamble” barcode (Hex Equivalent is LB):
(Page 32 of old Bar Code manual, “REV.B”; page 41 of new Bar Code manual, “REV.B-2/97”)
5. Scan the “Postamble 1” barcode (Hex Equivalent is 0):
6. Scan the “Postamble 2” barcode (Hex Equivalent is D):

7. Scan the “Postamble 3” barcode six times (Hex Equivalent is 0):

Hardware
8. Scan the “Confirmation” barcode and verify “01234567” appears after the DOS prompt with
an error “Bad command or file name”. This is normal since DOS doesn’t know what to do
with this information:
Intermec (Pencil) Barcode Scanner
To program the Intermec (Pencil) Barcode Scanner to be used with the IMMULITE, exit to DOS
and perform the following steps:
Note: When scanning the barcodes below, a single high beep indicates a successful scan, while
three low beeps indicates an invalid scan.
1. Scan the below barcodes to set the factory settings.
Null Config.
$ + T A 3
Default Config.
. +
2. Scan the below barcode to configure for an IBM AT U.S. Keyboard.
Config. IBM AT Key
$ + T A 1

3. The Enter key on a personal computer is typically a carriage return <CR>. To set the
postamble to <CR>, scan the barcode below.
Carriage Return
$ + A C " < C R > "

4. To test that the programming was successful, scan the barcodes below and verify the text
string below the barcode appears after the DOS prompt.
Test 123
T e s t 1 2 3
Welsh Allyn Scanner
The manufacturer Welsh Allyn has made changes to the firmware of the barcode scanner
currently supplied with new IMMULITE systems. This change may causes problems in certain
scanning modes for the software screens. Inadvertent commands for carriage return/line feed
functions of the scanner may occur. This may lead to undesired entry into some software fields.
Another indication of this problem involves a series of rapid, repeated ‘beeping’ noises coming
from the system’s computer during scanner use.
The scanner can be reset by scanning in 2 barcodes: the first is a ‘Factory Default Settings’
compatible for IMMULITE’s, followed by an additional ‘Add CR (carriage return) suffix’
setting command. These barcodes are represented below. These barcodes are also found in the
manufacturer’s Operator Manual page 11-1 (Rev. D manual), or on page 12-1 (Rev. E manual).
Note: Once scanned, this internal command change becomes ‘permanent’ within the scanner,
any future entry of this extra scan of ‘Add CR Suffix’ should not be necessary.
The Instrument Serial Numbers containing scanners which need this re-programming are K4575
through K4755. For all systems beyond this number range the firmware correction will be preset
prior to shipping.

Hardware
6.3 Power and Communication Tips
PC Communication Errors:
The error can occur for several reasons. Often it is self-correcting and will say “ PC IMMULITE
COMM FAILURE. Check your cable connections now. Resuming normal operation in 15
seconds.” (on the IMMULITE One display). It indicates that the communication between the PC
and the IMMULITE One has been interrupted. In some cases as described below, you should try
to salvage the customer’s run as your first priority…however, you should still be certain to
investigate the original cause of the communication error as well, not just correct it.
PC com errors commonly happen when an operator is printing something while running, even if
results or errors are not currently printing, if there is a paper jam, or if the printer is turned off
and they will generally self-correct.
Frequent self-correcting PC Comm errors can also result from electrical noise in the lines, due to
the IMMULITE One being close to other large equipment (i.e. other instruments, centrifuges
etc.). Cable connections can also be loose and should be checked and tightened.
PC COM errors can also occur with large databases. Procedures can be performed to correct the
problem and are handled on an individual basis.
You can also get PC Comm errors if the Epson printer is in PAUSE or the Citizen printer is off-
line (refer to printer section). If the operator catches it early enough and takes the printer out of
PAUSE or puts it back on-line, the run and report printing will continue undisturbed. If
however, the condition is not corrected soon enough, the primary screen can “freeze”, and will
not update or respond to the keyboard:
If someone gets a PC Comm error and the screen freezes (won’t respond to the keyboard):
1. Press “CTL/ALT/DEL” to escape out of the software (soft boot).

2. Exit to DOS
3. Type FIXIT. FIXIT will delete open records; therefore all tests with open records will need
to be repeated.
4. Type PC (standard mode) or PCSTAT (for turbo mode)(see ancillary program section for
details)
5. Answer the usual start-up questions
6. If you get "Can not communicate with Immulite, Do you wish continue?” answer “Y” for
"yes".

Power and Communication Tips
There is a 50/50 chance to save their run. After logging back onto the primary screen have the
operator search for a patient in PATIENT ENTRY (pressing F1) for sample cup they know is on-
board. If they see "Assay in Progress", at least some of the results were salvaged. If they see
"Record Not Found", the run is gone. Saving the run all depends on where the database was
broken. They may loose test between the time of the PC Comm error and logging back onto the
Primary screen. Time is the critical factor in this case. The chances of losing the run are greater
when you reboot the system, however if the operator calls immediately there is still chance.
There may be times when operators are kicked out to DOS in the middle of a run. In some
instances you can still salvage the run by going in through PC or PCSTAT, as described in steps
4-6 above. There may be times when it doesn’t work but running PC should always be
attempted.
Remember that PC is a simulation and the primary screen will NOT reflect the actual position of
the samples running on the system. Also, while in the PC mode, operators should finish their
current run only and not load any new samples on the system. Once the samples already in
progress have resulted they should log off, and go back in to the system with Run IMMULITE or
Start Turbo to run any remaining samples.
Error 88:
If you get kicked out to DOS in the middle of a run and the message “Error 88” appears on the
monitor in DOS, the database is broken. FIXIT should correct the problem but the error is fatal
and the run is almost always lost.
Power Issues:
If a customer has a problem with power ask the following questions:
• Have you had any power glitches/electrical storms/lights flicker?

• Is the IMMULITE One plugged in?
• Do you have any LED lights on the IMMULITE One? Which ones? Have them check the 4
LEDs in the electronics area and also the sample barcode reader and reagent ones. If it is a
fuse this will narrow down the problem.
If IMMULITE display is still blank after downloading Run IMMULITE and following the
prompts, check rainbow colored ribbon cable connections in back of display panel.

Hardware
6.4 Printer Tips
Epson (Model LX-300)
1. Be certain the printer is not in PAUSE. You will get PC communication errors if in “pause”
mode. Press “pause” again and results will print.
2. Problem: Printer starts printing double space; restore to single space by changing the Auto
Line Feed feature on the printer:
• Turn printer off
• While holding the FONT button, turn on the printer
• Current language settings are printed (release the FONT button when the printing starts)
• Press LF/FF –it keeps the language in English and then prints the table of current settings
• Press LF/FF again to enter the settings table
• Look at the FONT light 1 and FONT light 2 and the Pause Light (these indicate the status
of a setting).
• Press FONT button repeated, until 3 lights show the following display:
° ° •
blinking blinking off
This is addressing the Auto Line Feed Feature
• Press “Pause” button to show current condition of the this setting (all three lights are
probably “on”, which indicates this feature is armed)
• Turn off this feature by pressing the FONT button so that all three lights go out
• • •
off off off
• Switch printer off to save settings.
3. Draft is the best font to use. Roman and Sans Serif bold print so it takes longer to print, than
draft condensed

Printer Tips
Citizen (Model GSX190)
1. Be certain the printer is on-line during operation. If the printer is off-line while results or
error messages are trying to be sent, you will get PC communication errors.

Hardware
6.5 Computer Input/Output Views
The following pages contain photos of IMMULITE computer input/output panels (back panel).
The configuration and position of the jacks vary depending upon the brand and model of the
computer. Currently there are a variety of brands and models in the field.
Compaq Deskpro
COM1:IMMULITE Unused
COM2:LIS
Printer
Mouse
Unused
Keyboard/ Monitor
Scanner Unused

Computer Input/Output Views
Compaq Proline A 4/33S
Mouse COM1: IMMULITE

Keyboard/ Scanner
COM2: LIS Printer Monitor
IBM 300 GL
COM2: LIS Keyboard/Scanner
COM1:
IMMULITE Mouse
Printer
Not used Monitor

Hardware
IBM 433/DP
Monitor
Printer
COM2: LIS
Keyboard/Scanner
Mouse COM1: IMMULITE
Linden Group
COM1: IMMULITE
Printer Unused
Monitor
Mouse
Unused COM2: LIS Unused

Keyboard/Scanner

Computer Input/Output Views
Linden Group Newer Computer
Mouse Printer COM2: LIS

Unused
Keyboard/Scanner Unused
Unused COM1:
IMMULITE

Hardware

Chapter 7. Software
7.1 Ancillary Programs
Export
This program allows the operator to view, print or save the data to a floppy disk, for
troubleshooting or report consolidation purposes. Patient data is retained by the database for 31
days. Controls, adjustor and, calibration verification data for 6 months.
1. From the Start-Up menu, select EXIT TO DOS.

2. Type EXPORT and enter.
3. Enter any 3 characters to name the file or press Enter.
4. You are then prompted to select the desired starting and ending dates and times for data
collection. REMEMBER…YOU CAN ONLY VIEW UP TO 31 CALENDAR DAYS. You
will also select the test type (or press enter to default to ALL) and the type of data to be
viewed (or press enter to default to ALL). You can either print all data types at once by
selecting all, or print each one individually…you cannot select two or three data types at
once.
5. A box appears, summarizing your choices, and asks if you would like to print, send the
information to the display, to a disk in drive a or b, or to a hard disk. Choose the desired
option.
6. Once data is generated, answer Y or N to “Do you wish to continue getting data from this
file?” If no, type START at the DOS prompt and press Enter.
7. If the data was sent to a disk, the operator can open it in another PC (NOT THE PC
CONNECTED TO THE IMMULITE One)…they will be asked which application they want
to open it in. If they select Excel, it will display the data in a spreadsheet format, allowing for
data manipulation.
Status
This is the cumulative error log from the beginning of the use of the IMMULITE. If the
database is replaced, the error log will not reflect any errors prior to the replacement date.
The Status log can be quite large, so it is unlikely that you would want to print the entire log.
Using the memory joggers at the bottom of the page, you can move your cursor to the beginning
of the portion you would like to print, and press F4 to mark. Arrow your cursor down to
highlight the desired area and press F3 to print the marked sections. F4 will unmark the area
again when done.

Software
Remember that the Status log will also contain slopes and intercepts for all adjustments.
The oldest information will display first in the error log; to get to the most recent information,
press CTL PAGE DOWN simultaneously and you will be brought to the last page of the log.
PC
Some diagnostic programs require certain information to be received from the instrument (i.e.
results from the Barcode Reader) using the “pc” program. The “pc” program allows access to a
“simulated primary screen” for diagnostic purposes. This screen is not to be used for running
actual tests. The “pcstat” program should not be used except for the rare circumstance listed in
the following note.
Note: In some rare circumstances, communication may be lost (“PC Communication Failure”)
during a run. If the IMMULITE is still running normally, the “pc” program may be used to track
the chemistry run progress. If a TURBO chemistry run is in progress, the user must use the
“pcstat” program. Care must be taken to use the correct program “pc” or “pcstat” depending on
the assay run in progress, otherwise the display and indexing of the instrument motions may be
incorrect and “mis-matched”.
To run the “pc” or “pcstat” program, follow the steps below:

1. After the diagnostic program begins running (after pressing GO on the IMMULITE), press
[Esc].
2. From the Start-up menu, select EXIT TO DOS.
3. Type pc or pcstat and press [Enter].
4. Respond to the questions displayed by pressing [Enter] three times.
5. When the following message appears:
6. Cannot communicate with the IMMULITE.
Continue running? Y/N
7. Choose [Y] for yes.
8. To exit, select Log Off and Log Off System.

Ancillary Programs
GETDATAT
Some diagnostic programs require obtaining raw CPS data from the Luminometer via a data
collection program called “getdatat” (if getdatat is needed it will be listed in the “other program
required” column of the diagnostic program table in the diagnostic section of the Operator’s
Manual). This program must be started after the diagnostic program has been loaded and before
the tube is counted by the PMT. To run the “getdatat” program, follow the steps below:
1. After the diagnostic program begins running (after pressing GO on the IMMULITE), press
[Esc].
2. From the Start-up menu, select EXIT TO DOS.
3. Type getdatat and press [Enter]. A menu appears.
4. Press [P] to turn on the printer (if a printout is desired).
Note: Make sure the printer is on-line/not in pause and properly loaded with paper.
5. Press [S] to “collect and store” the data.
6. Respond to the next three questions by pressing [Enter] after each. If desired, you may name
the file for future reference.
7. Once all the counts desired have been printed, stop the IMMULITE by pressing ALARM
MUTE and GO (on the IMMULITE).
8. Press [Esc] and then [Q] to quit the data collection program.
WATER
WATER is the data collection program for the WATERTPM and WATERTST diagnostics. This
program will subtract the substrate blank reading from each test unit. It takes into account the
PMT factor for that instrument. If the CPS for substrate alone are near the cutoff value, check
the PMT multiplier. Divide the substrate alone CPS by the PMT multiplier to get the actual
CPS. GETDATAT will give the actual CPS since it doesn’t take the PMT multiplier into
account.
1. Once the water test program is loaded in the diagnostics menu, and the test units start
moving, press [Esc] and EXIT TO DOS.
2. At the DOS prompt, type WATER and press [ENTER]. You will get a box asking you to
choose which diagnostic you are running, select either Watertst or Watertpm.
3. A “Waiting for data” message will appear and results will be posted in about 10 minutes.
4. Once the readings are complete and print, press [Esc] to exit to DOS and START to return to
the IMMULITE One Start-Up menu.

Software
KITS
The kits program is used to enter assay and kit lot specific information into the software. It is
also where the CAF, PMT factor and dark count limits are entered for that instrument.
THE KITS PROGRAM IS NOT FOR CUSTOMER USE…IT IS FOR INTERNAL USE
ONLY. THERE ARE SOME RARE CIRCUMSTANCES WHEN CUSTOMERS MAY WANT
TO ALTER CERTAIN INFORMATION CONTAINED IN THIS PROGRAM, AS
EXPLAINED BELOW, WITH MANAGEMENT CONSENT AND WITH TECHNICAL
SERVICE SUPERVISION. THE BEST OPTION IN THIS SCENARIO, IF AT ALL
POSSIBLE, IS TO HAVE A TSR GO INTO THE KITS PROGRAM ON-SITE AND MAKE
THE NECESSARY CHANGES, RATHER THAN INSTRUCTING THE CUSTOMERS TO
DO SO. AGAIN, YOU MUST CHECK WITH MANAGEMENT BEFORE YOU TAKE
CUSTOMERS INTO THIS PROGRAM.
To access the kits program, from the Start-Up menu select Exit to DOS. At the prompt type
“KITS”.
You will then be prompted to enter a password, which is “KITS”…again, do not give this
password out to a customer unless management approval was obtained.
The Kits menu screen is then displayed, as shown below:
The KIT PARAMS (Kit Parameters) option appears as the following:

Ancillary Programs
The parameters listed represent the lot information, curve parameters and most current
adjustment information. The “Conc. Low” and “Conc. High” fields provide the actual dose for
the low and high adjustor…the software needs it in this format for processing.
By hitting the PAGE UP and PAGE DOWN keys you can scroll through the kits. The kits
included in this menu reflect the assays and kit lots currently scanned in by the operator.
QUICK KITS, as seen below, is just a summary of the lot numbers and curve parameters for that
kit lot. Again, PAGE UP and PAGE DOWN will scroll through the currently entered kit lots:

Software
The TEST PARAMS (Test Parameters) screen appears below:
Each test is assigned a number and name, which appear in the first two lines.
The screen also reports the default and alternate units for each assay, including the report
multiplier for each. The currently selected unit is also displayed.

Ancillary Programs
The adjustment frequency is expressed as the “days between curve adjust”
The “lower bound for answer” and “upper bound for answer” fields reflect the reportable range
for that assay. This is one area that some customers may wish to alter. If they feel that our assay
is not linear over our package insert reportable range, they would need to adjust these values to
reflect their findings…doing so would open or close the range accordingly.
Note: If a lab chooses to open the range (extend the reportable range beyond our package insert
claims) it constitutes off-label use and is NOT supportable by DPC- THIS MUST BE MADE
VERY CLEAR TO THE CUSTOMER PRIOR TO ANY CHANGES BEING MADE.
Vet labs will commonly do this, but they are not subject to the same regulations as a clinical
lab…none the less, get permission before taking them there.
The “user assay low” and “user assay high” reflect the currently selected patient reference
ranges. Customers would change these values in Start-Up Menu/Configurations/Assay Settings,
and would not have to access KITS to do so.
Reagent volumes used for the assay are listed.
The “formula” field describes the assay format and therefore the equation used to define the
stored master curve.
The color number listed corresponds to the color key listed at the bottom of the page and reflects
the color assigned to that assay.
The number of reagents used for the assay are listed.
The “sig digits” field determines the number of significant digits. The number entered for that
particular kit will determine the number of decimal places reported, as follows:
TSH : Other:
Result < 1
Result <= 1
.xx
.xxx
Result < 100 and >=1
Result < 10 and > 1
xx.x
x.xx
Result > 99.9
Result < 100 and >= 10
xxxx.
xx.x
Result > 99.9
|xxxx.

Software
The low and high adjustor CV limits are also displayed on this screen. These are the limits the
software will use after an adjustment when comparing the 4 adjustor replicates. If the 4
replicates exceed the listed CV, one of them will be dropped and the CV re-calculated based on
the remaining 3. If the CV is still higher than the limit, the instrument fails the adjustment and
only the failed level would need to be repeated (before log-off). Generally, sandwich assay low
adjustors will have a limit of 15% (they are usually true zeros and will therefor experience more
variation). Competitive assay low adjustors and all high adjustors will usually have a 10% limit.
The chemiluminescent attenuation factor is entered in the “ATTEN FACTOR” screen:
This value is determined, entered and verified by manufacturing personnel. If you go into this
screen you must re-type the factor in before exiting. Be certain to enter the correct factor so as
not to effect sample results.
The PMT multiplier is entered in the MULT. PMT screen:
This value is determined, entered and verified by manufacturing personnel. If you go into this
screen you must re-type the factor in before exiting. Be certain to enter the correct factor so as
not to effect sample results.
The PMT dark limit is entered in the DARK LIMIT screen:
The current limit for all instruments is 300.

Program Descriptions and Database Repair
7.2 Program Descriptions and Database Repair
Backup- Removes all patient, adjustor and control data older than 31 calendar days. Compacts
(makes smaller) the database and stores on disk. Contains the error log, patient database, QC
database, and configuration files. An analogy would be making a copy of a video tape.
Restore- Takes a copy of the database created with the backup function and overwrites the
current database. For example, using the video tape analogy, you tape your favorite TV show
“Dieting with Dave” and you make a copy (backup). On the original tape you also add to the
end of the tape “Big John’s Aerobics”. The original tape goes bad. When you copy the backup
to the original you only have “Dieting with Dave”
FIXIT- If a database is corrupt, this program attempts to repair the database. It is not always
successful.
FIXDB- When the operator logs off the instrument a copy of the database is made (if the auto
backup feature in configurations is active). FIXDB works the same as the restore feature
described above, using the copy off the hard drive.
CHKDSK- The hard drive can encounter errors. This program attempts to repair the errors.
DEFRAG- Over time the hard drive can become fragmented. An analogy would be you have a
videotape with “Dieting with Dave”. Instead of being in one spot on the tape, the second half is
near the end. Halfway through you would need to fast-forward the tape to see the second half.
This is what happens with files on the disk. The DEFRAG program places the files so they are
continuous and not segmented along the disk. This program only increases performance.
BACKDAT- The backdat feature allows the customer to copy their entire database onto a floppy
disk. It contains the patient database plus troubleshooting messages. This disk can then be
viewed by technical services, field services and software as needed to aid in the
troubleshooting/diagnosis of a problem. To copy a customers database, exit to DOS, insert a
formatted floppy into the drive and type: backdat. THIS MUST BE DONE PRIOR TO THE
CUSTOMER PERFORMING A DAILY BACKUP.
Repair database procedure:
1. Perform CHKDSK to see how much damage exists (if over 10 there will probably be data
loss) then CHKDSK/F to fix
2. Run DEFRAG/F to defragment the hard drive and optimize disk space.
3. Run FIXIT; if not successful, continue.
4. Run FIXDB; if not successful, continue.
5. Restore from backup disk.

Software
Error 88:

Software Tips
7.3 Software Tips
7.3.1 Significant Digit Options:
There is an option in the TEST PARAMETERS menu of the KITS program that allows for
selection of the number of significant digits to be reported for a test (refer to Ancillary Programs,
Kits program, for details). The field appears as:
Sig Digits 1=TSH 2=Other
The number entered for that particular kit will determine the number of decimal places reported,
as follows:
TSH: Other:
Result <= 1 Result < 1

.xxx .xx
Result < 10 and > 1 Result < 100 and >=1

x.xx xx.x
Result < 100 and >= 10 Result > 99.9

xx.x xxxx.
Result > 99.9

xxxx.
7.3.2 Deleting the database:
1. Make sure the customer understands that controls, kits, adjustments and patients will all have
to be redone/re-entered.
2. Make sure the customer prints out all their QC data
3. Make sure that the customer has the current software installation disk (e.g. v. 3.16)
4. Obtain the PMT and CAF from KITS and write this info down. LIS information is also
needed.
5. Go to the PC directory: Exit to Dos, Type "CD." [enter]

Software
6. Type CD_PC [enter] (underscore = space)

7. Type: del_*.ism [enter]
8. Install the current software version: A:install_A:new [enter]
9. Put in the CAF and PMT values back into KITS.
7.3.3 Date Time Conflict:
If a customer is experiencing a date time conflict, consult an engineer for the proper course of
action to take for that particular scenario. Each situation is really handled on a case by case
basis. This can happen if the date is set earlier than the date of the last resulted specimen.
7.3.4 Deleting Records:
Records will automatically get deleted if no result is posted to it before midnight.
Upon log-off, if there are records that have no answers, you will get prompted accordingly, and
asked, “do you want to delete records without answers?” Answering yes will delete those
records.
If an error is made identifying a sample cup, the record can be edited but not deleted until either
log-off, or midnight, as described above. There is no other way to delete records.
7.3.5 Editing Records:
If an error was made while entering patient information, or if information needs to be added to a
patient record, it can be done any time before the sample is read at the PMT. Go into either
Worklist or Patient Entry and type in the sample cup number then press Enter. The purple and
yellow edit box appears. It displays the records already existing for that cup number and asks
which record you want to edit or do you want to create a new patient. If you want to change an
existing record, select the desired one.
In Worklist Entry you can edit the accession number right in the purple box (notice the field is
blue, meaning it is available). If you need to edit any other information, press Enter and the
record is displayed on the first line, allowing you to edit accession number, name or dilution
factor. (NOTE: If the “Skip last name” option is selected and active, you will not be able to edit
any other information. The accession number field will be accessible in the purple edit box, but
upon hitting enter the record will be dropped back into the worklist without you being able to
edit name or dilution factor. Turn the skip name option off by hitting F1 and re-type the sample
cup number).

Software Tips
In Patient Entry you cannot edit any information in the purple edit box…type the sample cup
number, hit enter, select the appropriate record or highlight create new patient, and hit enter to
bring that record up. The existing information appears and allows you to change or enter new
information.
When using the purple edit box, be certain you choose your option based on what you really
want to do…remember that you cannot delete records so if information is wrong for a patient
you want to edit it, not create a new record for that cup number. The first result out will go to the
first record created for that cup number (time created is displayed in the far right corner of the
box for each record). So, if the first record for cup number 1 is wrong, and you choose to create
a new patient, rather than edit the first record, the result will still print out with the information
from record number 1 which is incorrect. In order to get a result for the second record, you
would have to run cup 1 twice…in other words, only select “create a new record” if you are
going to run that sample cup more than once.
7.3.6 Printing Screens or Reports:
The primary screen in the IMMULITE One software can NEVER be printed. It prints in code,
not graphics and since the screen is updated every cycle, it will reprint the code every 31 or 45
seconds (Run IMMULITE or Turbo mode respectively), until the run is completed, thus
interfering with report/error printing.
All other screens in the operating software can be printed with the F10 key.
The worklist in the “Worklist Entry” screen can also be printed with the F3 key…this will print
the complete worklist, without any headings. F10 can still be used but each page in the worklist
would have to be printed individually and all of the heading information would be included.
The software will not allow you to “print reports not printed today” or “print reports by date and
time” (both options found under: SYSTEM STATUS: SELECT REPORTS) if samples are still
running on the instrument.
It is also recommended that they not try to print screens etc while samples are on the system, as
this will generate “PC Communication Errors” (refer to power/communication section for
details).
When not in the IMMULITE One operating software, screen printing varies based on the screen:
The Levy-Jennings plots can be printed using the F10 key.
Other DOS based screens can only be printed using the “print screen” key on the keyboard.
HOWEVER, a bug exists in DOS where screens are not always consistently printed using
the “print screen” key, and partial printing of a page may result.

Software
7.3.7 Error 88:
7.3.8 Control Entry:
There is currently no place in the software to look up the control ranges already entered for any
control and/or assay. One way to check if and what has been entered, is to go into Data Entry,
Patient Entry and use Page Up and page Down and find the cup with the control. The range of
the control will appear on that screen along with “ASSAY IN PROGRESS”. Another way is to
run the control for the assay in question. The entered range will be displayed at the top of the
control report printout.
If you need to edit any information in the control identification screen you must re-enter all test
codes and levels for that assay. Also, if a control is running and has gone through the barcode
reader, changes made to the control identification will not be applied to that control. The
changes however will then be applied to any controls subsequently run (provided they went
through the barcode reader after the changes were made).
Up to 25 different controls can be identified to the system in the control entry screen.
7.3.9 Entering Control Ranges for Qualitative Assays:
When entering control information for qualitative assays designate:
• negative controls as 0
• positive controls as 1
• indeterminate as 2
7.3.10 Searching for records:
You can search from the DATA ENTRY: PATIENT ENTRY screen and HISTORY REVIEW:
PATIENT REVIEW for patient records only…you cannot search for adjustors and controls.
You have to scroll through the records using page up and page down to find adjustor and control
records. You can search for patient results by sample cup number, accession number and patient
last name only…type the information in the respective field and leave the cursor in that field,
then press F1. If the cursor is not in the field of search, you will get a message.

Software Tips
7.3.11 Long Report Format:
Use the memory joggers at the bottom of the screen to guide you in customizing the long report.
Remember that:
Fields cannot be created. The existing fields correspond to the available fields in the Patient
Entry screen. You cannot alter the Patient Entry screen, therefore, if you try to create a new field
in Long Report Format there will be no place to input that data in PATIENT ENTRY. Fields can
be deleted (the field will still appear in patient entry but not on the long report) or moved.
Anything typed into the screen (which appears in white text) will be printed on every report.
This includes text, characters and lines.
Customers can add the name of their facility to their long reports by deleting “your Town
Hospital” and typing their name and address at the top of the page. The “Change Name” option
in the configurations menu ONLY changes the name that appears in the IMMULITE One
operating software header, not on reports.

Software
7.4 Software Scenarios/Case Studies:
7.4.1 Case Study 1:
Customer gets adjustment printout. At bottom of the page there is no slope and intercept printed,
only the following message:
“adjustor lots between replicates don’t match”
Cause: This can happen when reagent or test unit lots cross kit lots. For example, kit lot 7 and
kit lot 8 both have reagent lot 4. The instrument can run components from either lot, so not all
replicates may have the same reagent or test unit lot…the printout should indicate which lots
were used for each replicate. When components cross kit lot numbers, the box should contain a
brightly colored important notice, telling them to remove components from lot 7 while adjusting
lot 8 (using the above example). The software is doing what it should do and will not adjust in
this case.
7.4.2 Case Study 2:
Customer gets adjustment printout and there is no slope and intercept printed. All 8 replicates
are accounted for, there are no errors, no pc comm or bad parity failures and all lots match. The
next day the kit was still identified as “new kit” in the reagent status display.
Cause: This can happen if they order multiple adjustments for the same kit. For example, they
order:
2 lows 1 high
1 low 2 high
2 lows 2 highs
7.4.3 Case Study 3:
Customer reports that an EXPORT printout shows “0” counts in the CPS column for a patient.
In looking at the error log for that day there are numerous “No reagent for approaching XXX
tube…”
Cause: The second reagent for that assay was not available for pipetting when needed, either
because it was removed or was a mismatched lot. The result for that patient will be expressed as
an “ERROR”, but “0” will be posted to the CPS column in export for that sample. It is not an
actual expression of the sample’s CPS, but a default function of the “ERROR” message for that
tube.

Software Scenarios/Case Studies:
7.4.4 Case Study 4:
A customer is running a water test, using WATER to retrieve their data. They get the error
“Overflow in line XXXXXXXX)
Cause: This is a current problem with the WATER program and can occur when running
watertst or watertpm. You need to run the water test again, using GETDATAT, because the
results are greater that the water program can handle (results greater than 10,000 CPS prior to the
PMT factor being multiplied).

Software

Chapter 8. LIS (Laboratory Information Systems)
The purpose of the LIS feature is to allow results to be uploaded to a host (LIS) computer
system. The IMMULITE is also able to accept broadcast downloads of workorders from the LIS
and send individual requests for workorders to the LIS via the host query function.
The industry reference is ASTM 1394 – Standard Specification for Low-Level Protocol to
Transfer Messages Between Clinical Laboratory Instruments and Computer Systems.
IMMULITE – LIS Cable wiring reference is ASTM E1381 (5.2.4.2) The LIS Vendor supplies
the cable to the IMMULITE.
8.1 Upload of results
1. The operator must tag and send results (all or individually) from the Data Management
screen.
2. Autosend is not available
3. Results can be sent only once; there is no resend feature.
4. <F4 > tags all results
5. <F5> tags only one result. <F5> also untags tagged results.
6. <F1> sends the results to the LIS.
7. The results in the LIS Data Management screen can be printed by pressing <F3>
8. If the system is Uni-directional, accession numbers MUST be entered form the Worklist
entry screen, or results will not be sent to the LIS.

LIS
8.2 Broadcast Download
1. The LIS can download a group of workorders for various specimens. In the LIS Data
Management screen the operator can assign sample cup numbers individually or have the
IMMULITE auto-number the workorders.
2. Using the arrow keys, select the sample where the numbering process should begin. Press
<F2> and type the starting number. Sample cup numbers are assigned in numerical order
3. Worklist entry screen can also be used to assign sample cup numbers to accession numbers.
8.3 Host Query
1. Customers can use the hand held laser scanner to scan barcode labeled tubes. See hand held
laser scanner manual if the scanner needs to be programmed to read a certain symbology.
2. The accession number must be entered from the Worklist Entry screen or patient results will
not be sent to the LIS.
3. After the accession number is scanned in, the IMMULITE will query the LIS what tests
(workorders) need to be run.
4. An error of Record not found can indicate a programming bug in the LIS. Request the LIS
Vendor’s data stream and examine the terminator message for terminator codes.
8.4 Configuring LIS
1. From the LIS parameters, select LIS PARAMS. The password is “connect.”
2. For a UNI-DIRECTIONAL SYSTEM:
a. Activate the LIS feature? – YES
b. Activate Host Query? – NO
c. Activate Uni directional Mode? YES
d. Enter Header Message Password (LIS Vendor needs to give this info to customer)
e. Enter Receiver ID (LIS Vendor provides ID)
f. Enter Sender ID (LIS Vendor provides ID)
g. Enter Baud Rate - Most common choice is 9600
3. IF asked, the PARITY is NONE, DATA BITS 8, STOP BITS 1 (this is not included in the
manual and needs not be entered in the IMMULITE. LIS Vendors will get this from the
IMMULITE LIS specifications).
4. Save changes.

Possible Errors
8.5 Possible Errors
Invalid ID – This is the most common error. The Sender ID and Receiver ID are incorrect in the
header message. TRY reversing the Sender ID and Receiver ID’s in IMMULITE LIS
PARAMS.
Invalid Password – the password is incorrect in the header message. Correct by entering the
proper password in the LIS PARAMS. This password is assigned by the LIS Vendor. Note:
Sunquest does not use a password. This field may be left blank.
Bad or Missing Frame Number – The frame number in the message is not proper. Usually
indicates a programming bug in the LIS software, but may be a bad message caused by noise on
the line (cable). See ASTM 1394 Logical layer section 6.3.2 for further detail.
Invalid Sequence Number – The sequence number in the message is not proper. Usually
indicates a programming bug in the LIS software, but may be a bad message (line noise). See
ASTM 1394 section 6.6.7 for further detail.
Message Too Short – Data within the message was dropped or not sent. Usually indicates a
programming bug in the LIS software, but may be a bad message (line noise.)
LIS Timeout – The LIS is not responding to the IMMULITE. The problem is usually with the
LIS. Check the cable is connected properly; the LIS Vendor should check they have provided
the correct cable. This may also be a hardware related communication problem or programming
but in the LIS software. The LIS will not show anything when the IMMULITE gives this error.
The error means the IMMULITE is attempting to send and the LIS gives no acknowledgement.
Rarely a bad communication port on the IMMULITE computer could cause this. The LIS Test
cable p/n 400245 or LIS Test cable/Software kit (LIS Comm program and Instructions) p/n
400843 could be sent to the account to check the communication port. Field service engineers
can check the communication port on-site.
<CR> or <LF> Missing in LIS Transmission – Usually indicates a programming bug in the
LIS software, but may be a bad message (line noise).
Error in Last Request – This is a response FROM the LIS stating the LIS encountered an error
to the IMMULITE's request for information.
No Info on This # - A response from the LIS to a Query message. The LIS has no information
for the sample (accession #).
8.6 Addendum
1. IMMULITE – LIS Cable Wiring ASTM E1381 (5.2.4.2)

2. Document – How the LIS Comm Program Works

LIS

Chapter 9. Miscellaneous
9.1 Bottle Volumes And Tests Per Bottle:
Bottle: Total Volume: Volume used per test: Approximate Number of tests
per full bottle:
Water 2 liters Approximately 3-4 ml 450
Probe Wash 1 liter Approximately 1 ml 1000
Substrate 105 ml 0.200 ml 500
Liquid Waste 3.75 liters 4-5 mls 900

Miscellaneous
9.2 Recommendations for Low Volume Use Customers
Prior to Operation (If system has not been used for several days)
√ Fill clean water bottle with fresh distilled water.

√ In Diagnostics, run DECON1 using the fresh distilled water. See Operator’s Manual 7 – 10.
At End of Operation (If system will not be used for several days)
√ Remove water bottle, rinse with 70% isopropyl alcohol; invert to dry. See Operator’s
Manual 6 – 16.
√ Place water bottle straws in a second clean dry water bottle. Be sure that both the tubings
and the end of line filters do not come in contact with anything other than the water bottles
themselves.
Monthly (In addition to monthly maintenance)
√ Decontaminate the system with fresh probe wash. See Operator’s Manual 6 – 23.
Reminders for Low Volume Usage
√ Follow Package Insert recommendations for storage of reagents, adjustors, and control
materials.
√ Store distilled water away from direct sunlight.
√ Replace substrate bottle after 30 days on the instrument (discard any remaining substrate).
See Substrate Module Package Insert.
√ Replace probe wash solution after 30 days on the instrument.

Index
—A— —F—
adjustment theory Final Documentation in Clientele, 3-4
intercept, 2-6
slope, 2-6
Adjustment Theory, 2-5
—G—
control results, 2-7 General Troubleshooting, 3-1
Analytical Sensitivity, 2-33 Assay Troubleshooting, 3-2
Assay Information, 2-36 Control and Adjustor Problems, 3-10
Allergy, 2-36 CPS Troubleshooting, 3-5
Anemia, 2-37 Leftover Testunits, 3-14
Application Kits, 2-46 Non-Mechanical Troubleshooting, 3-8
Available Outside the USA, 2-46 Patterns in data, 3-9
Bone Metabolism, 2-37 Substrate Decon, 3-13
Cardiac Markers, 2-38 Syringe Errors, 3-25
Diabetes, 2-38 Typical Problems
Drugs of Abuse, 2-39 Air in System, 3-15
Infectious Disease (TORCH), 2-39 Calc Errors, 3-18
Other Assays, 2-45 High CPS, 3-21
Reproductive Endocrinology, 2-40 Insufficient Substrate, 3-17
Therapeutic Drug Monitoring, 2-41 Insufficient Wash Water, 3-17
Thyroid Function, 2-41 Load Chain Errors, 3-22
Tumor Markers, 2-43 Low CPS, 3-19
Turbo Assays, 2-44 Luminometer, 3-24
Veterinary, 2-45 Negative CPS, 3-18
No Power, 3-25
Noisy Pump, 3-15
—B— Probe Dripping, 3-23
Barcode Reader, 5-15 Probe Wash, 3-23
BOTTLE VOLUMES AND TESTS PER BOTTLE:, 9-1 Reag Carousel Temp Errors, 3-23
Reagent Barcode Read Errors, 3-16
Reagent Level Sense Errors, 3-16
—C— Shuttle Errors, 3-24
Testunit and Sample Cup Barcode Read Errors, 3-17
CAF and PMT Factor, 2-22
Tip Jam, 3-22
chemistry
Water Issues, 3-12
chemiluminescence, 2-3
competive assay, 2-2
data reduction, 2-4 —H—
Chemistry
sandwich assay, 2-1 Hardware, 6-1
Intermec (Pencil), 6-4
—D— PSC, 6-2
Welsh Allyn, 6-5
Diagnostic Programs, 5-1
Power and Communication
APRIME-ATTENTM, 5-2
PC Comm Errors, 6-6
MESG-PROBANGL, 5-7
Printers, 6-8
PROBETST-REAGENTP, 5-8
SCHANGE-SHUTTLE, 5-9
SOLE1W-SPINON, 5-10 —I—
SUBSHEAT-UPDOWNH, 5-11
UPDOWNW-V2TEST, 5-12 Introduction, 1-1
V4TEST-WTRTEM50, 5-13
—E—
Error MessageTable, 4-1
IMMULITE Troubleshooting Guide 600414 1

Index
—P—
—L— Pipettor, 5-32
LIS (Laboratory Information Systems), 8-1 Precision or Accuracy Problems, 3-26
Broadcast Download, 8-2
Configuring LIS, 8-2 —R—
Host Query, 8-2
Possible Errors, 8-3 Reagent Carousel, 5-39
Upload, 8-1
Load Platform, 5-19
Low Volume Use Customers, 9-2
—S—
Luminometer, 5-22 Shuttle, 5-45
Software
—M— Ancillary Programs
EXPORT, 7-1
Main Carousel, 5-27 GETDATAT, 7-3
Mechanical Modules KITS, 7-4
Barcode Reader, 5-15 PC, 7-2
Load Platform, 5-19 STATUS, 7-1
Luminometer, 5-22 TEST PARAMS, 7-6
Main Carousel, 5-27 WATER, 7-3
Pipettor, 5-32 Case Studies, 7-16
Reagent Carousel, 5-39 Database Repair, 7-9
Shuttle, 5-45 Software Tips, 7-11
Temperatures, 5-54
Water and Substrate Pumps, 5-58
Method Verification Data Review Guidelines, 2-29
—T—
Temperatures, 5-54
—O—
One Adjustor Assay, 2-10
—W—
Water and Substrate Pumps, 5-58
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Document number: 600414

CHAPTER 1. INTRODUCTION............................................................................... 1-1

CHAPTER 2. CHEMISTRY ..................................................................................... 2-1

2.2 One Adjustor Assay Seminar .........................................................................................2-10

2.3 Two-Point Adjustment ...................................................................................................2-19

2.4 The Effects of Altering the CAF and PMT ....................................................................2-22

2.5 Method Verification Data Review Guidelines ...............................................................2-29

2.6 Analytical Sensitivity .....................................................................................................2-33

2.7 Assay Information ..........................................................................................................2-36

CHAPTER 3. GENERAL TROUBLESHOOTING ................................................... 3-1

3.2 Assay Troubleshooting Worksheet ..................................................................................3-2

3.3 Are you running now?......................................................................................................3-3

3.4 Final Documentation in Clientele ....................................................................................3-4

3.5 CPS Troubleshooting .......................................................................................................3-5

3.6 Investigation of QC/Assay Issues.....................................................................................3-7

3.7 Non-Mechanical Troubleshooting Tips............................................................................3-8

3.8 Patterns in data .................................................................................................................3-9

3.9 Chemistry Troubleshooting Tips....................................................................................3-10

IMMULITE Troubleshooting Guide 600414 i

For Internal Use Only

3.10 Typical IMMULITE problems.......................................................................................3-15

3.11 Precision or Accuracy ....................................................................................................3-26

3.12 Precision vs. Accuracy Grid...........................................................................................3-31

CHAPTER 4. ERROR MESSAGE TABLE.............................................................. 4-1

CHAPTER 5. MECHANICAL MODULES ............................................................... 5-1

5.2 Diagnostics Description Chart..........................................................................................5-2

5.3 Barcode Reader ..............................................................................................................5-15

5.4 Load Platform.................................................................................................................5-19

5.5 Luminometer ..................................................................................................................5-22

5.6 Main Carousel ................................................................................................................5-26

5.7 Pipettor ...........................................................................................................................5-31

5.8 Reagent Carousel............................................................................................................5-38

5.10 Syringe Pumps................................................................................................................5-48

5.11 Temperatures ..................................................................................................................5-53

ii 600414 IMMULITE Troubleshooting Guide

For Internal Use Only

5.12 Water and Substrate Pumps............................................................................................5-57

CHAPTER 6. HARDWARE ..................................................................................... 6-1

6.2 Laser Scanner Programming ............................................................................................6-2

6.3 Power and Communication Tips ......................................................................................6-6

6.4 Printer Tips .......................................................................................................................6-8

6.5 Computer Input/Output Views .......................................................................................6-10

CHAPTER 7. SOFTWARE...................................................................................... 7-1

7.2 Program Descriptions and Database Repair.....................................................................7-9

7.3 Software Tips .................................................................................................................7-11

7.4 Software Scenarios/Case Studies: ..................................................................................7-16

IMMULITE Troubleshooting Guide 600414 iii

For Internal Use Only

CHAPTER 8. LIS (LABORATORY INFORMATION SYSTEMS)............................ 8-1

8.2 Broadcast Download ........................................................................................................8-2

8.3 Host Query .......................................................................................................................8-2

8.4 Configuring LIS ...............................................................................................................8-2

8.5 Possible Errors..................................................................................................................8-3

8.6 Addendum ........................................................................................................................8-3

CHAPTER 9. MISCELLANEOUS ........................................................................... 9-1

9.2 Recommendations for Low Volume Use Customers .......................................................9-2

iv 600414 IMMULITE Troubleshooting Guide

For Internal Use Only