Installation Implementation Guide

P/N 105422D
October 2010

EC REP
Beckman Coulter Ireland, Inc.
Mervue Business Park,
Mervue, Galway,
Ireland (353 91 774068)

Printed in U.S.A.
© 2010 Beckman Coulter, Inc.
250 S. Kraemer Blvd. • Brea, CA 92821
This guide is intended for use with the Access 2 Immunoassay System. This guide also can be used as
supplemental material for the UniCel DxC 600i and the SYNCHRON LX i 725 systems, which consist
of an Access 2 system integrated with another Beckman Coulter system.

Beckman Coulter, Inc. grants a limited non-exclusive license to the Access 2 system owner or operator
to make a copy of all or a portion of this book solely for laboratory use.

Ostase and Hybritech are trademarks of Hybritech Incorporated and are registered in the USPTO.
Hybritech Incorporated is a subsidiary of Beckman Coulter, Inc.

Beckman Coulter, the Beckman Coulter logo, Access, SYNCHRON LX, UniCel, and AccuTnI are
trademarks of Beckman Coulter, Inc. and are registered in the USPTO.
Access 2 Installation Implementation Guide Table of Contents

Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
• Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
• How to Use This Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
• Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi

1 Performance Verification Studies Overview. . . . . . . . . . . . . . . . . . 1-1

• CLIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Verification Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
• Complexity Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

2 Calibration Verification and Linearity . . . . . . . . . . . . . . . . . . . . . . . 2-1

• Calibration Verification Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
• Materials and Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
• Set-Up and Running. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
• Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
• Linearity Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Automatic Verification of Linearity . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Verification of Linearity by the Dilution Method . . . . . . . . . . . . . . . . . 2-2
• Reference CLSI Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
• Materials and Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
• Preparing the High Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
• Preparing Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Alternate Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Set-Up and Running. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Data Reduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Calibration Verification / Linearity Worksheet . . . . . . . . . . . . . . . . . . . . . . . . 2-5

3 Precision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Materials and Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Set-Up and Running . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Data Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Expected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Reference CLSI Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Precision Summary Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

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Access 2 Installation Implementation Guide Table of Contents

4 Method Comparison. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

• Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
• Materials and Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
• Set-Up and Running . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
• Analysis of Discrepant Patient Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
• Data Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
• Expected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
• Reference CLSI Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
• Infectious Disease Assays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
• Terminology for Correlation and Method Comparison Studies . . . . . . . . . . . . 4-4
• Method Comparison Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
• Method Comparison Concordance Table Worksheet . . . . . . . . . . . . . . . . . . . . 4-6

Installation Assay Verification Checklist . . . . . . . . . . . . . . . . . . . . . .A-1

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Access 2 Installation Implementation Guide Preface

Preface
Introduction Beckman Coulter Inc. is pleased to present this Installation Implementation Guide,
designed to help you integrate your new Access 2 Immunoassay System into your
laboratory.
We provide an overview of the verification process, as well as procedural guidelines
to assist you with precision evaluation, calibration verification and linearity, and
method comparison studies. Please take time during the installation of your system to
review these thoroughly with your Beckman Coulter Application Specialist.
We hope you find the information we've provided useful as you make the transition to
your Access 2 System.

NOTE
This guide is made available primarily to address accrediting requirements for
laboratories in the U.S. as defined by the Clinical Laboratory Improvement
Amendments (CLIA) and regulated by the U.S. Centers for Medicare and
Medicaid Services. Laboratories outside the U.S. should comply with local
regulatory requirements and accrediting agencies.

How to Use Within the tabbed sections of this guide you will find discussions, procedures, and
This Guide worksheets to assist you with each stage of the verification process. Please note that
the procedures provided outline the general steps for verifying the performance of
your new system. However, your current laboratory policies or your local regulatory
agency may dictate more specific rules for your laboratory to follow.
We suggest that you use the Installation Documentation section to store all of your
installation records and subsequent performance verification data.
The Appendix provides additional helpful information.

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Preface Access 2 Installation Implementation Guide

Contact Technical Information

Information If you have any questions about this information, or for technical assistance regarding
the Access 2 Immunoassay System, contact Beckman Coulter.
• In the U.S.A. or Canada, contact Beckman Coulter Technical Support by phone at
800-854-3633, or online at www.beckmancoulter.com/customersupport. Before
using online support the first time, you will need to register online.
• Outside the U.S.A. and Canada, contact your local technical support
representative.

Ordering Information
For ordering assistance, call 1-800-526-3821.

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Access 2 Installation Implementation Guide 1: Performance Verification Studies Overview

1
Performance Verification
Studies Overview
CLIA The Clinical Laboratory Improvement Amendments have a significant impact on the
laboratory and method evaluation.* It is often confusing to determine what is needed
for accreditation and certification for the different types of testing categories.

The procedures in this guide will assist you in evaluating a new instrument or clinical
test. Not all of them are required by CLIA; however, some may be required by the
College of American Pathologists (CAP), the Joint Commission of Accreditation of
Healthcare Organizations (JCAHO), or individual state agencies. It is important to
know your state's requirements, as well as those of any other accrediting agencies.

Your laboratory must compile its own policies and procedures manual for method
evaluation, in compliance with the appropriate accrediting agencies. You are
empowered to make your own decisions as to what procedures are appropriate, and
which performance limits or specifications are acceptable.

The data generated from some of these procedures will help to establish the baseline
performance of your Access 2 System. When you have completed your method
evaluation, you must maintain the data for as long as the procedure is used, plus an
additional two years.

* The Centers for Medicare and Medicaid Services (CMS) State Operations Manual (Appendix C: Sur-
vey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, Rev. 1), pub-
lished May 2004, provides details on how to comply with the CLIA regulations.
Internet: http://cms.hhs.gov/manuals/Downloads/som107ap_c_lab.pdf

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1: Performance Verification Studies Overview Access 2 Installation Implementation Guide

Verification The following is a synopsis of performance characteristics often verified. For more
Synopsis details, please refer to any textbook on clinical chemistry or the available CLSI
protocols.*
• Calibration Verification/Linearity. Linearity refers to the overall system
response, (i.e. the final analytical result rather than instrument output). It is
demonstrated when a plot of a range of observed values against expected
values results in a straight line. Linearity does not prove accuracy, unless
you use standards with accurately assigned values.

• Precision Evaluation. Precision is a measure of the reproducibility of assay

results. An assay may be evaluated for both within-run and between-run
variation, which together contribute to total imprecision. The protocol
provided in this guide is for assessing total imprecision, using control
material or a patient pool.

• Method Comparison and Accuracy. When changing analytical methods or

systems, most laboratories perform these studies to evaluate differences in
recovery between methods, allowing for adjustment of the reference range,
if necessary. Comparing to a reference method and measuring assayed
control materials may be used to prove accuracy.

Complexity The Access 2 Immunoassay System has been categorized by CLIA '88, Regulation
Classification 42CFR493, as moderately complex for all assays, with the following exceptions,
which are highly complex:

• Folate (Red Blood Cell)

• Cortisol Urine (Extraction Procedure)

• AFP for Open Neural Tube Defect (ONTD); serum and amniotic fluid

* Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS)

940 West Valley Road, Suite 1400
Wayne, PA 19087-1898 USA
Phone: (610) 688-0100
Fax: (610) 688-0700
Internet: http://www.clsi.org/

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Access 2 Installation Implementation Guide 2: Calibration Verification and Linearity

2
Calibration Verification and
Linearity
Calibration Calibration verification entails performing the calibration and ensuring that it is
Verification acceptable by measuring controls and comparing the results to pre-determined target
Discussion ranges.

Materials and Samples

• Access reagent pack for each assay (This procedure will use 15 or 17 tests/assay,
depending on the number of calibrator levels in the set).

• One Access calibrator set for each assay. (Refer to the Assay Instructions For Use
for specific handling instructions.)

• Quality control material for each assay. Use the material that you will be
measuring routinely when the assay is completely online.
− Use tri- or bi-level controls whenever possible.
− Always prepare fresh controls, strictly observing the manufacturer's product
insert instructions.

Set-Up and Running

1. Calibrate each assay.
2. Test one replicate of each control.

Expected Results
The calibration must be accepted, and all controls should be within ± 2 SD of their
assigned values.

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2: Calibration Verification and Linearity Access 2 Installation Implementation Guide

Linearity Verifying the linearity, or reportable range, ensures that the test system is correctly
Discussion calibrated within the range that patient results are reported. It is verified with the same
data used for calibration verification. If the instrument accepts the calibration curve,
and the control response is acceptable, the reportable range and linearity are
confirmed.
Alternatively, the linearity may be verified by measuring three or more commercially
prepared standards in duplicate, or by performing a traditional dilution-method
linearity study.

Automatic Verification of Linearity

Access 2 software uses the "Precision Profile Method" to accept or reject a
multi-point calibration curve. This method can be used for any dose response curve in
which the minimized summed squares of the residuals are calculated to give the best
fit from the obtained calibration data.
For multi-point, quantitative assays, the software uses a 4-parameter logit-log curve
(4PLC), weighted smoothing spline, or straight line math model to fit the calibration
data. Each of these data fitting models uses a minimized summed square of the
residuals to fit the data. Weighting over the S0 to highest calibrator range is used in
the curve fitting process to "normalize" the variance of the relative light unit (RLU)
signal, thus allowing equal contribution of all calibrators to the curve fit and to the
sum squared total of residual error. The signal is then compared to set acceptance
limits at strategic points along the curve. The acceptance limits are factory set from
assays that were used to verify or validate labeling performance claims for the assay.
This method is intended to ensure that, when a curve is accepted, the analytical
response of subsequent assays will be linear throughout the stated reportable range.
The reportable range is inclusive of the lower limit of detection up to the assigned
value of the highest calibrator.

Verification of Linearity by the Dilution Method

It is redundant to measure dilutions of the calibrator to assess the linearity of a
multi-point curve. However, if you wish to perform linearity testing beyond the
calibration verification, you may use the following optional procedure. It is important
to note that this procedure uses calibrator material, which, according to CLSI
guidelines, verifies linearity, but not patient sample recovery.

Reference CLSI Document

To perform recovery testing using materials other than calibrators, refer to CLSI
Document EP06 A, Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved Guideline - First Edition.

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Access 2 Installation Implementation Guide 2: Calibration Verification and Linearity

CAUTION
Always refer to the Assay Instructions For Use for sample dilution limitations,
including, but not limited to the following:

• Do not attempt to perform dilution-method linearity testing for the Free T3,
Free T4, and Thyroid Uptake assays. Dilution alters the ratio of free vs.
bound analyte. The only approximation possible for Free T3 and Free T4
linearity is to measure the calibrators as unknowns. There is no dilution
method for Thyroid Uptake.
• Toxoplasma and Rubella patient samples generally demonstrate recovery up
to 1:10, however certain samples may recover poorly because the Toxoplasma
and Rubella assays measure immunoreactive antibodies, which are affinity
and concentration dependent.

Materials and Samples

• Access reagent pack for each assay (10-12 tests/assay)
• One Access calibrator set for each assay
• Assay-appropriate diluent specified in the assay instructions for use

NOTES
• The procedure will consume a minimum of 2200 µL of diluent and 1800 µL
of the highest calibrator.
• Refer to the Assay Instructions For Use for calibrator handling instructions
and the appropriate diluent.

• Ensure that there is an active calibration for the assay before preparing the
high sample and making dilutions.

Preparing the High Sample

1. Pipette 200 µL of the appropriate diluent and 1800 µL of the highest calibrator
into a 13 x 75 mm test tube. This represents a 90% dilution of the highest
calibrator, and will be referred to in this procedure as the high sample.
2. Mix well, avoiding bubble formation.

NOTE
You may need to prepare a larger volume of high sample, as minimum sample
volumes vary between assays. Refer to the appropriate Assay Instructions For
Use to determine the total required volume of high sample. Remember to
include dead volumes.

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2: Calibration Verification and Linearity Access 2 Installation Implementation Guide

Preparing Dilutions
Prepare the dilutions for Levels 2-4 as defined in Table 2-1, using the previously
prepared high sample. Place in Access 2 mL sample cups.

Level Diluent High Sample Expected % of

(Cup #) (µL) (µL) High Sample

1 (Diluent) 800 0 0
2 600 200 25
3 400 400 50
4 200 600 75
5 (High Sample) 0 800 100

Table 2-1 Dilutions for Linearity Testing

Alternate Method
Measure undiluted S0-S4 calibrators and a 90% dilution of the highest calibrator
(450 µL highest calibrator plus 50 µL appropriate diluent).

Set-Up and Running

Measure each level in duplicate.

Data Reduction
Calculate the percent recovery by comparing the found concentration to the expected
using the following formula:
Found Concentration
% Recovery = × 100
Expected Concentration

Expected Results
The recovery should be ± 10% for each dilution. This may be interpreted more
leniently at the low end of the curve for assays with higher expected total imprecision.

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Access 2 Installation Implementation Guide 2: Calibration Verification and Linearity

Calibration Verification / Linearity Worksheet

Date:

System ID #: Serial #:

Analyte: Analytical Range:

Control ID Control Range Control Value Obtained

Found
Sample Level Expected % Recovery Comments
Rep 1 Rep 2 Rep 3

1
2
3
4
5

Reviewed by: Date Reviewed:

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Access 2 Installation Implementation Guide 3: Precision

3
Precision
Discussion Precision is a measure of the reproducibility of assay results. It is typically expressed
as coefficient of variation (%CV). In method evaluation, the term "imprecision" is
frequently used because it reflects the variability that occurs in replicate
measurements.

An assay may be evaluated for both within-run and between-run variation, which
together contribute to total imprecision. It is imperative to perform the testing in a
manner that measures the type of imprecision expressed in the Assay Instructions For
Use, which, unless stated otherwise, is total imprecision.

Complete precision studies prior to the method comparison study to verify optimal
system performance.

Materials and • Access reagent pack for each assay (30 or 45 tests/assay, depending on the number
Samples of controls used)

• Quality control material for each assay (15 tests/level)

− Use the material that you will be measuring routinely when the assay is
completely online.
− Use tri- or bi-level controls whenever possible.
− Always prepare fresh controls, strictly observing the manufacturer's product
insert instructions.

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3: Precision Access 2 Installation Implementation Guide

Set-Up and 1. For one run, fill one Access sample cup with sufficient volume to measure five
Running replicates (500 µL for most assays). Refer to the product IFU or Assay Summary
Tables (P/N 986228) for sample volumes for each assay.

2. Measure controls in five replicates.

3. Repeat steps 1-2 for a total of three runs. (Beckman Coulter Inc. recommends a
minimum of 15 total replicates per control.)
• Ideally, perform only one run per day or shift. If the runs must be performed
on the same day, allow the system to completely aspirate the specimens for
one run before beginning the next.

Data Calculate the % CV for each group of 15 replicates using the following formula:
Reduction
SD
% CV = × 100
Mean

Expected Refer to the Assay Instructions For Use for expected imprecision results.
Results

Reference EP05-A2: Evaluation of Precision Performance of Quantitative Measurement

CLSI Methods; Approved Guideline - Second Edition
Document

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Access 2 Installation Implementation Guide 3: Precision

Precision Summary Worksheet

Date: System ID #:

System: Serial #:

Assay Mean S.D. %CV Expected %CV Comments

Reviewed by: Date Reviewed:

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Access 2 Installation Implementation Guide 4: Method Comparison

4
Method Comparison
Discussion Method comparison studies determine if the Access Systems test method and the
currently used method are clinically and numerically comparable.

NOTE
Perform the method comparison testing after the other verification studies have
been successfully completed.

Materials and • Access reagent pack for each assay (20 tests/assay)
Samples
• Patient samples for each assay (minimum of 20; minimum of 10 when comparing
one Access Family System to another)
− Ensure that the required storage conditions have been observed, as specified
in the Assay Instructions For Use.
− Select only specimens with adequate volume for possible re-testing. This will
prevent selectively eliminating problem samples later when analyzing
discrepant results.
− Select specimens using the distribution guidelines in the following table.

Analyte Concentration Relative to

Quantity*
Expected or Therapeutic Range

Below 5 (25%)
Within 10 (50%)
Above 5 (25%)
* For non-parametric ranges, choose samples from the lower, middle, and upper portions of the
assay curve.

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4: Method Comparison Access 2 Installation Implementation Guide

NOTES
• To avoid possible matrix effects, do not use controls or proficiency survey
samples for method comparison studies.
• When comparing two Access Family Systems:
− Calibrate both systems on the same day, from the same vial of calibrator,
using the same reagent pack lot.
− Never measure the same rack on two systems. Always pipette fresh
calibrators, QC, and samples individually for each system.

Set-Up and 1. Thoroughly re-suspend any frozen specimens after thawing. Centrifuge samples
Running for five minutes at 2200 RCF to remove all traces of particulate matter.

2. Measure one replicate of each patient.

3. Include controls to ensure validity of results.

• If possible, measure all patient specimens on the Access 2 assay and the reference
method on the same day. Failure to do so may contribute to poor correlation
results.

4. At the completion of method comparison testing, store all remaining specimens at

the appropriate temperature for possible subsequent discrepancy analysis. (Refer
to the Assay Instructions For Use for specimen handling requirements.)

Analysis of • Retest a specimen if:

Discrepant − The original test determination is from an invalid run.
Patient Results
− The original test determination has an associated instrument error.
− The Access 2 and reference method results correlate poorly.
• Perform all re-tests on both methods.

• Perform all re-tests immediately following the completion of any corrective action
taken to eliminate the source of invalidation.

• Eliminate from the study any samples that have insufficient volume remaining for
re-testing. (See Materials and Samples section.)

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Access 2 Installation Implementation Guide 4: Method Comparison

Data Perform a regression analysis on the data points using Deming calculations. Always
Reduction plot results from the reference method on the x (horizontal) axis and those from the
Access 2 assay on the y (vertical) axis. Do not include any results that are reported as
less than or greater than the reportable range of the assay.

NOTE
You must evaluate clinical concordance when there is no international standard
for an assay. This is particularly important for troponin I.

Expected No strict specifications exist for method correlation studies. Your laboratory will use
Results this information to determine if a new expected values range study is necessary.

Reference EP09-A2, Method Comparison and Bias Estimation Using Patient Samples;
CLSI Approved Guideline - Second Edition.
Documents
C28-A3, Defining, Establishing, and Verifying Reference Intervals in the Clinical
Laboratory; Approved Guideline - Third Edition.

Infectious Typically, infectious disease assays are verified by examining clinical concordance.
Disease For an expedited verification, measure a minimum of 50 samples with known clinical
Assays interpretation, using positive as well as negative samples.

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4: Method Comparison Access 2 Installation Implementation Guide

Terminology for Correlation and Method Comparison Studies

A correlation study is the evaluation of samples to determine the linear regression
of two methods or instrument systems. Conventionally, the known method or
Correlation Study
system is plotted on the x (horizontal) axis, and the new or experimental method or
system, on the y (vertical) axis.

A regression analysis is performed to determine the best linear relationship

between two variables. The Deming Regression statistical analysis distributes error
Regression evenly to x and y values. The equation of this line is of the form:
Analysis
y = mx + b
where m = slope, and b = intercept or offset

Slope is the ratio of y units to x units.

• Provides the angle of the best fit line of the graph.
Slope
• Deviation from a slope of 1 (ideal condition) defines the amount of proportional
error.

The intercept is the point where the regression line falls on the y axis. Deviation
Intercept
from an intercept of zero defines the amount of constant error.

The correlation coefficient indicates the degree of agreement between the two
variables for sets of data. Slope is:

Correlation • Calculated as a range between 0-1 (for this application).

Coefficient (R) • Equal to 1 when all data points fall directly on the regression line.
• Inversely proportional to random error (i.e. it decreases as random error
increases).

The Standard Error of the Estimate (SEE) is the standard deviation of the residual.
It indicates the dispersion of the data points about the regression line.
• Residual is the difference between the actual y and the calculated y from the
Standard Error of regression line.
the Estimate (SEE)
• Standard error is expressed in units of concentration having an ideal value of
zero.
• Deviation from the ideal represents the random error between methods.

A clinical concordance evaluation assesses agreement between methods with

Clinical
respect to clinical diagnosis. Clinical specificity and sensitivity and positive and
Concordance
negative predictive values may be calculated from concordance table data.

4-4 © 2010 Beckman Coulter, Inc.

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Access 2 Installation Implementation Guide 4: Method Comparison

Method Comparison Worksheet

Analyte: Date of Assay – Reference Method:

Date of Assay – Access 2 Method:

Reference System Access 2
Serial Number
System ID
Analyte
Reagent Pack Lot #
Calibrator Lot #
Reference Range
Analytical Range
Sample Storage Conditions

Value
Sample ID Comments
Reference Method Access 2
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Reviewed by: Date:

© 2010 Beckman Coulter, Inc. 4-5

P/N 105422D 10/10
4: Method Comparison Access 2 Installation Implementation Guide

Method Comparison Concordance Table Worksheet

Access 2 Positive Access 2 Negative

Individuals With Confirmed

Disease

Individuals Without Confirmed

Disease

# of diseased individuals with positive result

Sensitivity (%) = 100 × -----------------------------------------------------------------------------------------------------------
Total # of diseased individuals tested

# of individuals without disease with negative result

Specificity (%) = 100 × -------------------------------------------------------------------------------------------------------------------------------
Total # of individuals without disease tested

True Positives
Positive Predictive Value (PPV) = 100 × ----------------------------------------------------------------------------
True Positives + False Positives

True Negatives
Negative Predictive Value (NPV) = 100 × ---------------------------------------------------------------------------------
True Negatives + False Negatives

4-6 © 2010 Beckman Coulter, Inc.

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Access 2 Installation Implementation Guide A: Installation Assay Verification Checklist
AInstallation Assay Verification Checklist

Account
System ID Serial #:

Installation Assay Verification Checklist

The availability of these assays in your country depends on the status of submissions to local regulatory agencies. In
addition, an assay may not be available for use on all systems. Contact your Beckman Coulter representative if you
have questions about the availability of particular assays.
Precision Run Linearity Meth. Report Printed
Assay Calibration 1 2 3 (Optional) Comp. Prec. Lin. M.C.
Adrenal/Pituitary Cortisol ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Allergy Total IgE ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
EPO ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Ferritin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Diluted Ferritin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Folate ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Anemia
RBC Folate ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Intrinsic Factor Ab ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
sTfR ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Vitamin B12 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HAV Ab ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HAV IgM ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HBc Ab ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HBc IgM ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Blood Virus HBs Ab ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HBs Ag ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HBs Ab Confirm. ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HCV Ab Plus* ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HIV - 1/2 New* ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Ultrasensitive hGH ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Ostase ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Bone Metabolism Intact PTH - Routine ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Intact PTH -
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Intraoperative
AccuTnI ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
CK-MB ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Cardiovascular
Digoxin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Myoglobin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Diabetes Ultrasensitive Insulin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
CMV IgG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Rubella IgG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Infectious
Rubella IgM ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Disease
Toxo IgG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Toxo IgM II ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ

© 2010 Beckman Coulter, Inc. A-1

P/N 105422D 10/10
A: Installation Assay Verification Checklist Access 2 Installation Implementation Guide

Precision Run Report Printed

Linearity Meth.
Assay Calibration 1 2 3 (Optional) Comp. Prec. Lin. M.C.
Inflammation IL-6 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Total βhCG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Diluted Total βhCG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
DHEA-S ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Estradiol ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Unconjugated Estriol ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
hFSH ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Reproductive
hLH ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Inhibin A ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Progesterone ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Prolactin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
SHBG ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Testosterone ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Free T3 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Free T4 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Total T3 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Total T4 ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
HYPERsensitive hTSH ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Thyroid
Fast hTSH ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Thyroglobulin ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Thyroglobulin Ab II ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Thyroid Uptake ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
TPO Antibody ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Alpha-fetoprotein ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Diluted
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Alpha-fetoprotein
BR Monitor
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
(CA 15-3 Antigen)
CEA ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
GI Monitor
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Tumor Makers (CA 19-9 Antigen)
Hybritech PSA
• Hybritech Cal. ˆ   ˆ ˆ ˆ ˆ ˆ ˆ
• WHO Cal. ˆ   ˆ ˆ ˆ ˆ ˆ ˆ
Hybritech fPSA
• Hybritech Cal. ˆ   ˆ ˆ ˆ ˆ ˆ ˆ
• WHO Cal. ˆ   ˆ ˆ ˆ ˆ ˆ ˆ
OV Monitor ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
IL-6 RUO ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
RUO
PAPP-A RUO ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
Other
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ ˆ
* Sold by Bio-Rad for use on Beckman Coulter immunoassay systems. Bio-Rad is a registered trademark of Bio-Rad Laboratories, Inc.

Beckman Coulter Applications

Specialist Date

Laboratory Representative Date

A-2 © 2010 Beckman Coulter, Inc.

P/N 105422D 10/10