PREALBUMIN

1E02-21
304381/R1

PREALBUMIN
This package insert contains information to run the Prealbumin assay on the ARCHITECT c Systems and the
AEROSET System.

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.

Customer Support
United States: 1-877-4ABBOTT
Canada: 1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
International: Call your local Abbott representative

Symbols in Product Labeling

Calibrators 1 through 5 Reagent 1

Concentration Reagent 2

Contents of kit Catalog number/List number

Contains sodium azide. Contact
Serial number
with acids liberates very toxic gas.
Authorized Representative in the
Consult instructions for use
European Community
Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

October 2009
©2009 Abbott Laboratories

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NAME
PREALBUMIN
INTENDED USE
The Prealbumin assay is used for the quantitation of prealbumin in
human serum.
SUMMARY AND EXPLANATION OF TEST
Prealbumin (transthyretin or thyroxin-binding prealbumin) is synthesized
in the liver and is involved in triiodothyronine (T3), thyroxine (T4), and
vitamin A transport. Prealbumin is capable of binding two separate
ligands at unique binding sites. Each tetrameric prealbumin molecule
binds one molecule of retinol-binding protein (which complexes with
vitamin A) at one site and up to two molecules of T3 or T4 at another
site. Prealbumin is secondary to thyroxine-binding globulin in the
transport of T3 and T4.1
Because prealbumin has an extremely short half-life, quantitation
of prealbumin serum levels can provide a more timely and sensitive
assessment of protein malnutrition or liver dysfunction than transferrin
or albumin.2
Prealbumin is a very sensitive negative acute phase protein (or acute
phase reactant); decreased levels are associated with inflammation,
malignancy, liver cirrhosis, and protein diseases of the gut or kidneys.
Prealbumin levels also fall during periods of calorie/protein malnutrition;
therefore, during inflammatory processes with concomitant malnutrition,
levels fall rapidly and markedly. Decreased prealbumin levels are also
associated with cystic fibrosis, chronic illness, and some forms of
hereditary amyloidosis.1
Although the presence of acute or chronic inflammation may limit
its specificity, prealbumin can be a useful marker for assessing
protein‑energy nutritional status of maintenance dialysis patients.
In 2000, the Kidney Disease Outcomes Quality Initiative (K/DOQI)
recommended a prealbumin goal of ≥ 30 mg/dL, stating, “An individual
with predialysis or stabilized serum prealbumin of less than 30 mg/‌dL
should be evaluated for protein-energy malnutrition”.3 It has been
reported that serum prealbumin is higher in peritoneal dialysis patients
than in hemodialysis patients.4
Elevated prealbumin levels are associated with high doses of
corticosteroids, high levels of endogenous steroids secondary to
adrenal hyperactivity, high doses of nonsteroidal anti-inflammatory
medication, and Hodgkin’s disease.1
PRINCIPLES OF PROCEDURE
The Prealbumin assay is an immunoturbidimetric procedure that
measures increasing sample turbidity caused by the formation of
insoluble immune complexes when antibody to prealbumin is added to
the sample. Sample containing prealbumin is incubated with a buffer,
, and a sample blank determination is performed prior to the addition
of prealbumin antibody, . In the presence of an appropriate antibody
in excess, the prealbumin concentration is measured as a function of
turbidity.
Methodology: Immunoturbidimetric
REAGENTS
Reagent Kit
1E02 Prealbumin is supplied as a liquid, ready-to-use, two-reagent
kit which contains:
3 x 18 mL
3 x 6 mL
Estimated tests per kit: 242
Calculation is based on the minimum reagent fill volume per kit.
Reactive Ingredients Concentration
TRIS 100 mmol/L
Polyethylene Glycol 50 g/L
Anti-human prealbumin goat serum 30%
TRIS 100 mmol/L
Inactive Ingredients: and contain sodium azide (0.1%) as a
preservative.
2
REAGENT HANDLING AND STORAGE
Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
reagent level in the cartridge, causing insufficient reagent aspiration
which could impact results.
Reagent Storage
Unopened reagents are stable until the expiration date when stored
at 2 to 8°C.
Reagent onboard stability is approximately 57 days if quality control
results meet acceptance criteria. If quality control results do not meet
acceptance criteria, refer to the QUALITY CONTROL section of this
package insert.
WARNINGS AND PRECAUTIONS
Precautions for Users
1. For in vitro diagnostic use.
2. Do not use components beyond the expiration date.
3. Do not mix materials from different kit lot numbers.
4. Do not mix fresh reagent with in-use reagents.
5. CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.5 Biosafety Level 26 or other
appropriate biosafety practices7,8 should be used for materials that
contain or are suspected of containing infectious agents.
6. This product contains sodium azide. For a specific listing, refer to
the REAGENTS section of this package insert. Contact with acids
liberates very toxic gas. This material and its container must be
disposed of in a safe way.
NOTE: Refer to Section 8 of the instrument-specific operations
manual for proper handling and disposal of reagents containing
sodium azide.
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum is the acceptable specimen.
Serum: Use serum collected by standard venipuncture techniques into
glass or plastic tubes with or without gel barriers. Ensure complete clot
formation has taken place prior to centrifugation. When processing
samples, separate serum from blood cells or gel according to the
specimen collection tube manufacturer’s instructions.
Some specimens, especially those from patients receiving anticoagulant
or thrombolytic therapy, may take longer to complete their clotting
processes. Fibrin clots may subsequently form in these sera and the
clots could cause erroneous test results.
For total sample volume requirements, refer to the instrument-specific
ASSAY PARAMETERS section of this package insert and Section 5 of
the instrument‑specific operations manual.
Specimen Storage
Serum: Analyze fresh specimens if possible. Repeated freeze/thaw
cycles should be avoided to minimize potential protein degradation.
Temperature Maximum Bibliographic
Storage Reference
2 to 8°C 3 days 1, 9
-20°C 6 months 1
Teitz1 suggests storage of frozen specimens at -20°C for no longer
than the time interval cited above. However, limitations of laboratory
equipment make it necessary in practice for clinical laboratories to
establish a range around -20°C for specimen storage. This temperature
range may be established from either the freezer manufacturer’s
specifications or your laboratory standard operating procedure(s) for
specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
PROCEDURE RESULTS
Materials Provided Refer to the instrument-specific operations manual for information on
results calculations.
1E02 Prealbumin Reagent Kit
• ARCHITECT System Operations Manual—Appendix C
Materials Required but not Provided • AEROSET System Operations Manual—Appendix A
• 6E57 Prealbumin Calibrator, 1 x 1 mL Representative performance data are given in the EXPECTED VALUES
• Control Material and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure LIMITATIONS OF THE PROCEDURE
For a detailed description of how to run an assay, refer to Section 5 of Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
the instrument-specific operations manual. PERFORMANCE CHARACTERISTICS sections of this package insert.
Specimen Dilution Procedures The performance characteristics of Prealbumin on an analyzer other
than the ARCHITECT c Systems or the AEROSET System must be
The ARCHITECT c Systems and the AEROSET System have automatic validated and verified.
dilution features; refer to Section 2 of the instrument-specific operations Samples containing paraproteins (abnormal monoclonal antibodies)
manual for additional information. may interfere with test results. Samples with elevated total
Serum: Specimens with prealbumin values exceeding the highest protein concentrations or samples from patients with suspected
calibrator are flagged and may be diluted using the Automated Dilution paraproteinemia can be screened using other laboratory methods such
Protocol or the Manual Dilution Procedure. as protein electrophoresis.10
Turbidity and particles in the samples can interfere with the assay.
Automated Dilution Protocol Therefore, particulate matter should be removed by centrifugation prior
If using the Automated Dilution Protocol, the system performs a 1:4 to running the assay.
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. EXPECTED VALUES
Manual Dilution Procedure Reference Range
Manual dilutions should be performed as follows:
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. Serum11 Range* (mg/dL) Range* (g/L)
• The operator must enter the dilution factor in the patient or control 0 to 1 year
order screen. The system uses this dilution factor to automatically Male 7 to 25 0.07 to 0.25
correct the concentration by multiplying the result by the entered Female 8 to 25 0.08 to 0.25
factor.
> 1 to 12 years
• If the operator does not enter the dilution factor, the result must be
multiplied by the appropriate dilution factor before reporting the result. Male 11 to 34 0.11 to 0.34
NOTE: If a diluted sample result is flagged indicating it is less than the Female 12 to 30 0.12 to 0.30
linear low limit, do not report the result. Rerun using an appropriate > 12 to 60 years
dilution. Male 18 to 45 0.18 to 0.45
For detailed information on ordering dilutions, refer to Section 5 of the Female 16 to 38 0.16 to 0.38
instrument-specific operations manual.
> 60 years
The patient result flag “>” (ARCHITECT c Systems) and the EXT and
LH result error codes (AEROSET) may indicate antigen excess. Dilute Male 16 to 42 0.16 to 0.42
sample and rerun. Samples were tested for antigen excess up to Female 14 to 37 0.14 to 0.37
254.6 mg/dL (2.546 g/L). * Reference ranges are based on a 90% confidence interval.
CALIBRATION To convert results from mg/dL to g/L, multiply mg/dL by 0.01.
The linear high field of the assay parameters must be edited to the A study was conducted using 143 serum samples from volunteers.
concentration of the highest calibrator specified in the value sheet. Data were analyzed as described by Clinical and Laboratory Standards
Calibration is stable for approximately 57 days (1,368 hours) and is Institute (CLSI) protocol NCCLS C28-A.12 From this study, 95% of all
specimens fell within 17.77 to 36.35 mg/dL (0.18 to 0.36 g/L), with
required with each change in reagent lot number. Verify calibration with samples ranging from 14.47 to 40.07 mg/dL (0.14 to 0.40 g/L).
at least three levels of controls according to the established quality
control requirements for your laboratory. If control results fall outside It is recommended that each laboratory determine its own reference
acceptable ranges, recalibration may be necessary. range based upon its particular locale and population characteristics.
A multi-point (Linear) calibration curve is generated using Prealbumin
Calibrator.
For a detailed description of how to calibrate an assay, refer to
Section 6 of the instrument-specific operations manual.
For information on calibrator standardization, refer to the Prealbumin
Calibrator package insert.

QUALITY CONTROL
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Three levels of quality control are to be run every 24 hours.
• Run three levels of quality control with cartridge change.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.

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SPECIFIC PERFORMANCE CHARACTERISTICS SPECIFIC PERFORMANCE CHARACTERISTICS
Reportable Range (Accuracy by Recovery) (Continued)
The Prealbumin assay reportable range is from 3 mg/dL (0.03 g/L) to Precision
the highest calibrator concentration. Human serum containing a known The imprecision of the Prealbumin assay is ≤ 5.5% Total CV.
concentration of prealbumin was diluted with saline and the resulting Representative data from studies using CLSI protocols NCCLS
samples were analyzed. Observed mean results across the reportable EP5‑T214 and EP5-A15 are summarized below.
range were within 1 mg/dL (0.01 g/L) or 10%, whichever is greater, of
the target concentrations. Representative data are summarized below. Control Level 1 Level 2 Level 3
%Recovery = (Observed Mean / Target Concentration) × 100
N 80 80 80
Target Concentration Observed Mean Delta* Percent (%)
Mean (mg/dL) 13.4 21.2 31.2
(mg/dL) (mg/dL) (mg/dL) Recovery*
0.8 1.1 0.3 139.4 SD 0.12 0.18 0.80
Within Run
1.7 2.1 0.3 117.5 %CV 0.9 0.9 2.6
2.9 3.3 0.4 113.4 SD 0.11 0.15 0.48
5.8 5.6 -0.2 96.4 Between Run
%CV 0.8 0.7 1.6
11.6 11.3 -0.3 97.1
SD 0.35 0.14 0.51
23.3 23.3 0.0 100.0 Between Day
34.9 35.3 0.4 101.2 %CV 2.6 0.6 1.6
46.6 46.5 -0.1 99.8 SD 0.38 0.28 1.07
58.2 57.1 -1.1 98.2 Total
%CV 2.9 1.3 3.4
* Delta and %Recovery were calculated prior to rounding Target
Concentration and Observed Mean values. Method Comparison
Limit of Quantitation (LOQ) Correlation studies were performed using CLSI protocol NCCLS
EP9‑A.16
The LOQ for Prealbumin is ≤ 1 mg/dL (0.01 g/L). The LOQ is the
analyte concentration at which the CV = 20%. Performance studies Serum results from the Prealbumin assay on the AEROSET
produced an LOQ of 0.2 mg/dL (0.002 g/L). System were compared with those from a commercially available
immunoturbidimetric methodology.
Interfering Substances Serum results from the Prealbumin assay on an ARCHITECT c System
Interference studies were conducted using CLSI protocol NCCLS were compared with those from the Prealbumin assay on the AEROSET
EP7‑P.13 Interference effects were assessed by Dose Response and System.
Paired Difference methods, at the concentrations listed below.
AEROSET vs. ARCHITECT
Interfering Interferent Concentration N Target Observed Comparative Method vs. AEROSET
Substance (mg/dL) (% of Target)
N 80 95
30 mg/dL (513 µmol/L) 4 14.7 96.4
Bilirubin Y - Intercept 0.09 -0.45
60 mg/dL (1,026 µmol/L) 4 14.7 92.3
Correlation Coefficient 0.996 0.998
500 mg/dL (5.0 g/L) 4 13.6 91.2
Hemoglobin Slope 1.05 1.01
750 mg/dL (7.5 g/L) 4 13.6 88.6
Mean %Bias 5.7 -0.6
Human 750 mg/dL (8.5 mmol/L) 4 18.6 97.4
Range (mg/dL) 4.3 to 44.1 3.2 to 56.2
triglyceride 1,000 mg/dL (11.3 mmol/L) 4 18.6 98.6
1,000 mg/dL (10.0 g/L) 4 13.0 95.7
Intralipid
2,000 mg/dL (20.0 g/L) 4 13.0 64.0
Bilirubin solutions at the above concentrations were prepared by
addition of a bilirubin stock to human serum pools. Hemoglobin
solutions at the above concentrations were prepared by addition
of hemolysate to human serum pools. Human triglyceride solutions
at the above concentrations were prepared by mixing an elevated
triglyceride human serum pool with a normal triglyceride human serum
pool. Intralipid solutions at the above concentrations were prepared by
addition of Intralipid to human serum pools.

4
BIBLIOGRAPHY
1. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed.
Philadelphia, PA: WB Saunders; 1995:608–9.
2. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994:700.
3. K/DOQI clinical practice guidelines for nutrition in chronic renal
failure. Am J Kidney Dis 2000;35(Suppl 2):S20–2.
4. Goldwasser P, Feldman JG, Barth RH. Serum prealbumin is higher
in peritoneal dialysis than in hemodialysis: A meta-analysis. Kidney
Int 2002;62:276–81.
5. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
6. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
7. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
8. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
– Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory
Standards Institute, 2005.
9. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
10. Ledue TB, Collins MF, Ritchie RF. Development of
immunoturbidimetric assays for fourteen human serum proteins on
the Hitachi 912. Clin Chem Lab Med 2002;40(5):520–8.
11. Ritchie RF, editor. Serum Proteins in Clinical Medicine, Vol 1. AACC,
1996:9.01-6.
12. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
Reference Intervals in the Clinical Laboratory; Approved Guideline
(C28‑A). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1995.
13. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
National Committee for Clinical Laboratory Standards, 1986.
14. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices—Second Edition;
Tentative Guideline (EP5-T2). Villanova, PA: The National
Committee for Clinical Laboratory Standards, 1992.
15. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1999.
16. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline (EP9‑A).
Wayne, PA: The National Committee for Clinical Laboratory
Standards, 1995.

TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and
SmartWash are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are property of their respective owners.

Abbott Laboratories ABBOTT

Abbott Park, IL 60064 USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
304381/R1 +49-6122-580

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Prealbumin Serum—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash
● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: PAlb Type: Photometric Version: † Assay: PAlb
Number: 1062 COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 DIG00 Detergent B 345 1
Reaction mode: End up R1 AMIK9 Detergent B 345 1
Primary Secondary Read times R1 VANCO Detergent B 345 1
Wavelength: 340 / 700 Main: 31 – 33 R1 GENT9 Detergent B 345 1
Last required read: 33 R1 TOBRA Detergent B 345 1
Absorbance range: ___ – ___ Color correction: ___ – ___ R1 DGT0B Detergent B 345 1
Sample blank type: Self Blank: 14 – 16 R2 DIG00 Detergent B 345 1
R2 AMIK9 Detergent B 345 1
о Reaction definition ● Reagent / Sample о Validity checks R2 VANCO Detergent B 345 1
R1 R2 R2 GENT9 Detergent B 345 1
Reagent: PALB0 Reagent volume: 167 33 R2 TOBRA Detergent B 345 1
Diluent: Saline Water volume: ___ ___ R2 DGT0B Detergent B 345 1
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Cuvette Trig 10% Detergent B 345
Diluted Default Prealbumin Serum—Conventional Units
Dilution name Sample sample Diluent Water Dilution factor dilution
STANDARD : 3.0 ___ ___ ___ = 1:1.00 ● Configure assay parameters — Results
1:4 : 25.0 3.0 75 ___ = 1:4.00 о о General о Calibration о SmartWash ● Results о Interpretation
_________ : ___ ___ ___ ___ = о Assay: PAlb Assay number: 1062
Dilution default range: Result units: mg/dL
о Reaction definition о Reagent / Sample ● Validity checks Low-Linearity: 3
Reaction check: None High-Linearity: 54‡‡
Gender and age specific ranges:*
Maximum absorbance variation: ___ GENDER AGE (UNITS) NORMAL** EXTREME
Male 0 – 130 (Y) 18 – 45
Configure assay parameters — Calibration Female 0 – 130 (Y) 16 – 38
Either 0 – 130 (Y) 16 – 45
о General ● Calibration о SmartWash о Results о Interpretation
Assay: PAlb Calibration method: Linear
Configure result units
● Calibrators о Volumes о Intervals о Validity checks Assay: PAlb
Calibrator set: Calibrator level: Concentration: Version: †
PreAlb Blank: Water 0†† Result units: mg/dL
Cal 1: PreAlb1 ‡ Decimal places: 0 [Range 0 – 4]
Replicates: 3 [Range 1 – 3] Cal 2: PreAlb2 ‡
Correlation factor: 1.0000
Cal 3: PreAlb3 ‡
Intercept: 0.0000
Cal 4: PreAlb4 ‡
Cal 5: PreAlb5 ‡
Prealbumin Serum—SI Units
о Calibrators ● Volumes о Intervals о Validity checks Configure assay parameters — Results
Calibrator: PreAlb Diluted о General о Calibration о SmartWash ● Results о Interpretation
Calibrator level Sample sample Diluent Water Assay: PAlb Assay number: 1062
Blank: Water 3.0 ___ ___ ___ Dilution default range: Result units: g/L
Cal 1: PreAlb1 3.0 ___ ___ ___ Low-Linearity: 0.03
Cal 2: PreAlb2 3.0 ___ ___ ___ High-Linearity: 0.54‡‡
Cal 3: PreAlb3 3.0 ___ ___ ___ Gender and age specific ranges:*
Cal 4: PreAlb4 3.0 ___ ___ ___ GENDER AGE (UNITS) NORMAL** EXTREME
Cal 5: PreAlb5 3.0 ___ ___ ___ Male 0 – 130 (Y) 0.18 – 0.45
Female 0 – 130 (Y) 0.16 – 0.38
о Calibrators о Volumes ● Intervals о Validity checks Either 0 – 130 (Y) 0.16 – 0.45
Calibration intervals:
Full interval: 1368 (hours)
Calibration type: Configure result units
Adjust type: None Assay: PAlb
Version: †
о Calibrators о Volumes о Intervals ● Validity checks Result units: g/L
Blank absorbance range: _____ – _____ Decimal places: 2 [Range 0 – 4]
Span: Blank – Blank Correlation factor: 1.0000
Span absorbance range: _____ – _____ Intercept: 0.0000
Expected cal factor: 0.00
Expected cal factor tolerance %: 0
† Due to differences in instrument systems and unit configurations, version numbers may vary.
†† Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to the concentration specified on calibrator labeling or value sheet. In ARCHITECT software version 5.00 and above, these values are
defined on the Configure calibrator set screen.
‡‡ Edit to highest calibrator concentration specified in the calibrator value sheet.
* User defined.
** Reference range is from > 12 years to 60 years of age.

6
AEROSET SYSTEM ASSAY PARAMETERS

Prealbumin Serum—Conventional Units Prealbumin Serum—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page
Assay Name Assay # Line Assay Name Assay # Line
PAlb 62 A-Line PAlb 62 A-Line
Quantitative Ranges Quantitative Ranges
Min Text Min Panic-L L-Reference-H** Panic-H Max Max Text Min Text Min Panic-L L-Reference-H** Panic-H Max Max Text
* 0.0* 0.0 16 45 0.0 0.0* * * 0.0* 0.0 0.16 0.45 0.0 0.0* *
3 L-Linear Range-H 54‡‡ 0.03 L-Linear Range-H 0.54‡‡
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 18 – 45 16 – 38 0 Year 0.18 – 0.45 0.16 – 0.38
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0 Year
0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page

Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar
END UP 340 / 700 31 – 33 / 0 – 0 0.0 END UP 340 / 700 31 – 33 / 0 – 0 0.0
Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits
PAlb ( 62 ) 14 – 16 0–0 0.0 – 0.0 PAlb ( 62 ) 14 – 16 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 3.0 0.0 0 0 Rgt Name/Pos Standard 3.0 0.0 0 0 Rgt Name/Pos
Dil 1 25.0 3.0 75 0 Diluent: DILUENT C–10* Dil 1 25.0 3.0 75 0 Diluent: DILUENT C–10*
Dil 2 3.0 0.0 0 0 Type# 0 Dil 2 3.0 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 PALB011 – ___* 167 0 0 Reagent 1 PALB011 – ___* 167 0 0
Reagent 2 PALB012 – ___* 33 0 0 Reagent 2 PALB012 – ___* 33 0 0
Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum
___________ 1–1/1–1 0.0 – 0.0 0.0 ___________ 1–1/1–1 0.0 – 0.0 0.0
Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units
1.0 / 0.0 0 mg/dL 1.0 / 0.0 2 g/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 1368 Linear 1368
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 1 BLK – 1 0.0 – 0.0 3/3 1 BLK – 1 0.0 – 0.0
Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range
BLK Water 3.0 0.0 0 0 0.0 – 0.0 BLK Water 3.0 0.0 0 0 0.0 – 0.0
C1 PreAlb 1 3.0 0.0 0 0 Cal Deviation C1 PreAlb 1 3.0 0.0 0 0 Cal Deviation
C2 PreAlb 2 3.0 0.0 0 0 0.0 C2 PreAlb 2 3.0 0.0 0 0 0.0
C3 PreAlb 3 3.0 0.0 0 0 FAC Limit (%) C3 PreAlb 3 3.0 0.0 0 0 FAC Limit (%)
C4 PreAlb 4 3.0 0.0 0 0 10 C4 PreAlb 4 3.0 0.0 0 0 10
C5 PreAlb 5 3.0 0.0 0 0 C5 PreAlb 5 3.0 0.0 0 0

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
DGT0B11 AlkW 345 DGT0B11 AlkW 345
DGT0B12 AlkW 345 DGT0B12 AlkW 345
DIG0051 AlkW 345 DIG0051 AlkW 345
DIG0012 AlkW 345 DIG0012 AlkW 345
TOBRA41 AlkW 345 TOBRA41 AlkW 345
TOBRA42 AlkW 345 TOBRA42 AlkW 345
AMIK941 AlkW 345 AMIK941 AlkW 345
AMIK942 AlkW 345 AMIK942 AlkW 345
VANCO51 AlkW 345 VANCO51 AlkW 345
VANCO52 AlkW 345 VANCO52 AlkW 345
IRON042 AlkW 345 IRON042 AlkW 345
IRON052 AlkW 345 IRON052 AlkW 345
FER0B12 AlkW 345 FER0B12 AlkW 345
FER0B31 AlkW 345 FER0B31 AlkW 345
Cuvette Cuvette
Assay Name Wash Vol Assay Name Wash Vol
— — — — — —
Sample Probe Sample Probe
Wash Wash
— —
Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters.
* User defined or instrument defined.
** Reference range is from > 12 years to 60 years of age.
‡‡ Edit to highest calibrator concentration specified in the calibrator value sheet.
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