CHOLESTEROL

7D62-20
30-3126/R3

CHOLESTEROL
This package insert contains information to run the Cholesterol assay on the ARCHITECT c Systems™ and the
AEROSET System.

NOTE: Changes Highlighted

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 and 2 Catalog number/List number

Concentration Serial number

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

Reagent 1

ABBOTT LABORATORIES ABBOTT

Abbott Park, IL 60064, USA Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
September 2006
©2002, 2006 Abbott Laboratories

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NAME WARNINGS AND PRECAUTIONS
CHOLESTEROL Precautions for Users
1. For in vitro diagnostic use.
INTENDED USE
2. Do not use components beyond the expiration date.
The Cholesterol assay is used for the quantitation of cholesterol in
human serum or plasma. 3. Do not mix materials from different kit lot numbers.
4. Contains nonsterile bovine serum albumin.
SUMMARY AND EXPLANATION OF TEST 5. CAUTION: This product requires the handling of human specimens.
Measurement of serum cholesterol levels can serve as an indicator of It is recommended that all human sourced materials are considered
liver function, biliary function, intestinal absorption, propensity toward potentially infectious and be handled in accordance with the OSHA
coronary artery disease, and thyroid function. Cholesterol levels are Standard on Bloodborne Pathogens.7 Biosafety Level 28 or other
important in the diagnosis and classification of hyperlipoproteinemias. appropriate biosafety practices9,10 should be used for materials that
Stress, age, gender, hormonal balance, and pregnancy affect normal contain or are suspected of containing infectious agents.
cholesterol levels.1
The Adult Treatment Panel of the National Cholesterol Education SPECIMEN COLLECTION AND HANDLING
Program (NCEP) recommends that all adults 20 years of age and Suitable Specimens
over should have a fasting lipoprotein profile (total cholesterol, LDL
cholesterol, HDL cholesterol, and triglyceride) once every five years to Serum and plasma are acceptable specimens. The National Cholesterol
screen for coronary heart disease risk.2 Education Program (NCEP) recommends using fasting specimens.2
• Serum: Use serum collected by standard venipuncture techniques
PRINCIPLES OF PROCEDURE into glass or plastic tubes with or without gel barriers. Ensure
The use of enzymes to assay cholesterol has been studied by many complete clot formation has taken place prior to centrifugation.
investigators.3,4 This reagent is based on the formulation of Allain, Separate serum from red blood cells or gel as soon after collection
et al.5 and the modification of Roeschlau6 with further improvements to as possible.
render the reagent stable in solution. Some specimens, especially those from patients receiving
Cholesterol esters are enzymatically hydrolyzed by cholesterol anticoagulant or thrombolytic therapy, may take longer to complete
esterase to cholesterol and free fatty acids. Free cholesterol, including their clotting processes. Fibrin clots may subsequently form in these
that originally present, is then oxidized by cholesterol oxidase to sera and the clots could cause erroneous test results.
cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide • Plasma: Use plasma collected by standard venipuncture techniques
combines with hydroxybenzoic acid (HBA) and 4-aminoantipyrine to into glass or plastic tubes. Acceptable anticoagulants are lithium
form a chromophore (quinoneimine dye) which is quantitated at 500 nm. heparin (with or without gel barrier) and sodium heparin. Ensure
Methodology: Enzymatic centrifugation is adequate to remove platelets. Separate plasma from
red blood cells or gel as soon after collection as possible.
REAGENTS
Refer to the specimen collection tube manufacturer’s instructions for
Reagent Kit processing and handling requirements.
7D62 Cholesterol is supplied as a liquid, ready-to-use, single For total sample volume requirements, refer to the instrument-specific
reagent kit which contains: ASSAY PARAMETERS section of this package insert and Section 5 of
10 x 84 mL the instrument-specific operations manual.
Estimated tests per kit: 3,032 Specimen Storage
Calculation is based on the minimum reagent fill volume per kit.
Serum and plasma
Reactive Ingredients Concentration Temperature Maximum Bibliographic
Cholesterol Oxidase (Microbial) > 200 U/L Storage Reference
Cholesterol Esterase (Microbial) > 500 U/L 20 to 25°C 7 days 11
Peroxidase (Horseradish) > 300 U/L 2 to 8°C 7 days 11, 12
4-Aminoantipyrine 0.25 mmol/L -20°C 3 months 11
HBA 10 mmol/L
Guder et al.11 suggest storage of frozen specimens at -20°C for
The Abbott Clinical Chemistry Cholesterol reagent is certified to be no longer than the time interval cited above. However, limitations
traceable to the National Reference System for Cholesterol, against of laboratory equipment make it necessary in practice for clinical
the Abell-Kendall reference method in a CDC-Certified Cholesterol
Reference Method Laboratory Network (CRMLN). 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
REAGENT HANDLING AND STORAGE procedure(s) for specimen storage.
Reagent Handling NOTE: Stored specimens must be inspected for particulates. If present,
Remove air bubbles, if present in the reagent cartridge, with a new mix and centrifuge the specimen to remove particulates prior to testing.
applicator stick. Alternatively, allow the reagent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize PROCEDURE
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of Materials Provided
reagent level in the cartridge, causing insufficient reagent aspiration 7D62 Cholesterol Reagent Kit
which could impact results.
Materials Required but not Provided
Reagent Storage • 1E65 Multiconstituent Calibrator, 3 x 5 mL
Unopened reagents are stable until the expiration date when stored at • Control Material
2 to 8°C. • Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Reagent stability is 30 days if the reagent is uncapped and onboard.

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PROCEDURE (Continued) EXPECTED VALUES
Assay Procedure Reference Range
For a detailed description of how to run an assay, refer to Section 5 of Serum/Plasma
the instrument-specific operations manual.
Specimen Dilution Procedures Range (mg/dL) Range (mmol/L)
The ARCHITECT c Systems and the AEROSET System have automatic Child13
dilution features; refer to Section 2 of the instrument-specific operations Desirable < 170 < 4.40
manual for additional information. Borderline 170 to 199 4.40 to 5.15
Serum and plasma: Specimens with cholesterol values exceeding High ≥ 200 ≥ 5.18
705 mg/dL (18.26 mmol/L) are flagged and may be diluted using the
Automated Dilution Protocol or the Manual Dilution Procedure. Adult2
Desirable < 200 < 5.18
Automated Dilution Protocol Borderline 200 to 239 5.18 to 6.19
If using the Automated Dilution Protocol, the system performs a 1:4 High ≥ 240 ≥ 6.22
dilution of the specimen and automatically corrects the concentration by
multiplying the result by the appropriate dilution factor. To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0259.
The National Cholesterol Education Program (NCEP) Adult Treatment
Manual Dilution Procedure Panel III Report2 recommends the adult classification shown above.
Manual dilutions should be performed as follows: Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
• Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control SPECIFIC PERFORMANCE CHARACTERISTICS
order screen. The system uses this dilution factor to automatically
correct the concentration by multiplying the result by the entered Linearity
factor. Cholesterol is linear up to 705 mg/dL (18.26 mmol/L). Linearity was
• If the operator does not enter the dilution factor, the result must verified using Clinical and Laboratory Standards Institute (CLSI) protocol
be multiplied by the appropriate dilution factor before reporting the NCCLS EP6-P.14
result. Limit of Detection (LOD)
NOTE: If a diluted sample result is flagged indicating it is less than the The LOD for Cholesterol is 5.0 mg/dL (0.13 mmol/L). The LOD is
linear low limit, do not report the result. Rerun using an appropriate the mean concentration of an analyte-free sample + 2 SD, where
dilution. SD = the pooled, within-run standard deviation of the analyte-free
For detailed information on ordering dilutions, refer to Section 5 of the sample. A study performed on an ARCHITECT c System and an
instrument-specific operations manual. AEROSET System produced an LOD for the Cholesterol assay
of 0.80 mg/dL (0.021 mmol/L).
CALIBRATION
Limit of Quantitation (LOQ)
Calibration is stable for approximately 30 days (720 hours) and is
required with each change in reagent lot number. Verify calibration The LOQ for Cholesterol is 6.2 mg/dL (0.161 mmol/L). The LOQ is the
curve with at least two levels of controls according to the established analyte concentration at which the CV = 20%.
quality control requirements for your laboratory. If control results fall Interfering Substances15
outside acceptable ranges, recalibration may be necessary.
Interference studies were conducted using CLSI protocol NCCLS
For a detailed description of how to calibrate an assay, refer to
EP7-P.16 Interference effects were assessed by Dose Response and
Section 6 of the instrument-specific operations manual.
Paired Difference methods, at the medical decision level of the analyte.
For information on calibrator standardization, refer to the
Multiconstituent Calibrator package insert. Interfering Interferent N Target Observed
Substance Concentration (mg/dL) (% of Target)
QUALITY CONTROL 7.5 mg/dL (128 µmol/L) 4 252.3 91.7
The following is the recommendation of Abbott Laboratories for quality Bilirubin
15 mg/dL (257 µmol/L) 4 252.3 86.8
control. As appropriate, refer to your laboratory standard operating 750 mg/dL (7.5 g/L) 4 241.1 109.5
procedure(s) and/or quality assurance plan for additional quality control Hemoglobin
requirements and potential corrective actions. 1,000 mg/dL (10.0 g/L) 4 241.1 111.9
1,000 mg/dL (10.0 g/L) 4 236.1 102.5
• Two levels of controls (normal and abnormal) are to be run every Intralipid
24 hours. 2,000 mg/dL (20.0 g/L) 4 236.1 101.9
1.5 mg/dL (85 µmol/L) 4 282.2 98.7
• If more frequent control monitoring is required, follow the established Ascorbate
3 mg/dL (170 µmol/L) 4 282.2 97.6
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria Bilirubin solutions at the above concentrations were prepared by
defined by your laboratory, patient values may be suspect. Follow addition of a bilirubin stock to human serum pools. Hemoglobin
the established quality control procedures for your laboratory. solutions at the above concentrations were prepared by addition of
Recalibration may be necessary. hemolysate to human serum pools. Intralipid solutions at the above
• Review quality control results and acceptance criteria following a concentrations were prepared by addition of Intralipid to human serum
change of reagent or calibrator lot. pools. Ascorbate solutions at the above concentrations were prepared
by addition of ascorbic acid to human serum pools.
RESULTS Precision
Refer to the instrument-specific operations manual for information on The imprecision of the Cholesterol assay is ≤ 3% Total CV.
results calculations. Representative data from studies using CLSI protocol NCCLS EP5-A17
• ARCHITECT System Operations Manual—Appendix C are summarized below.
• AEROSET System Operations Manual—Appendix A
Control Level 1 Level 2
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this N 80 80
package insert. Results obtained in individual laboratories may vary. Mean (mg/dL) 261.4 129.2
SD 1.98 0.78
Within Run
LIMITATIONS OF THE PROCEDURE %CV 0.8 0.6
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC SD 1.01 1.03
Between Run
PERFORMANCE CHARACTERISTICS sections of this package insert. %CV 0.4 0.8
SD 3.36 1.64
Between Day
%CV 1.3 1.3
SD 4.03 2.09
Total
%CV 1.5 1.6

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SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) TRADEMARKS
Method Comparison AEROSET and ARCHITECT are registered trademarks of Abbott
Correlation studies were performed using CLSI protocol NCCLS EP9-A.18 Laboratories.
Serum results from the Cholesterol assay on the AEROSET System c System is a trademark of Abbott Laboratories.
were compared with those from a commercially available enzymatic All other trademarks, brands, product names, and trade names are the
methodology. property of their respective companies.
Serum results from the Cholesterol assay on the ARCHITECT c System
were compared with the Cholesterol assay on the AEROSET System.
AEROSET ARCHITECT
vs. Comparative vs. AEROSET
Method
N 79 101
Y - Intercept 0.933 -0.840
Correlation Coefficient 0.993 0.993
Slope 1.016 0.979
Range (mg/dL)* 70.6 to 416.8 39.5 to 687.6
*AEROSET Range

BIBLIOGRAPHY
1. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical
Chemistry, 5th ed. Philadelphia, PA: WB Saunders; 2001:480–5.
2. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
and treatment of high blood cholesterol in adults (Adult Treatment
Panel III). JAMA 2001;285:2486–97.
3. Flegg HM. An investigation of the determination of serum
cholesterol by an enzymatic method. Ann Clin Biochem 1973;10:79–
84.
4. Richmond W. Preparation and properties of a cholesterol oxidase
from Nocardia sp. and its application to the enzymatic assay of total
cholesterol in serum. Clin Chem 1973;19(12):1350–6.
5. Allain CC, Poon LS, Chan CS, et al. Enzymatic determination of
total serum cholesterol. Clin Chem 1974;20(4):470–5.
6. Roeschlau P, Bernt E, Gruber WA. Enzymatic determination of total
cholesterol in serum. Z Klin Chem Klin Biochem 1974;12:226.
7. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Occupational Exposure to
Bloodborne Pathogens.
8. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication
(CDC), 4th ed. Washington, DC: US Government Printing Office,
May 1999.
9. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization, 2004.
10. 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.
11. Guder WG, Narayanan S, Wisser H, et al. List of analytes—
preanalytical variables. Annex In: Samples: From the Patient to the
Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 12–3.
12. 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.
13. American Academy of Pediatrics, Committee on Nutrition.
Cholesterol in childhood. Pediatrics 1998:101(1);141–7.
14. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
15. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press; 1995:3-143–3-163.
16. 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.
17. 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.
18. 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.

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ARCHITECT c SYSTEMS ASSAY PARAMETERS

Cholesterol Serum/Plasma—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: Chol Type: Photometric Version: 1 Assay: Chol
Number: 1018
COMPONENT REAGENT / ASSAY WASH Volume Replicates
● Reaction definition о Reagent / Sample о Validity checks R1 ALBP0 Water 300 1
Reaction mode: End up
Primary Secondary Read times Cuvette Trig 10% Detergent B *** 345
Wavelength: 500 / 660 Main: 31 – 33
Last required read: 33
Absorbance range: ___ – ___ Color correction: ___ – ___ *** Select “Detergent B” for software prior to version 2.2.
Sample blank type: None
Cholesterol Serum/Plasma—Conventional Units
о Reaction definition ● Reagent / Sample о Validity checks
R1 Configure assay parameters — Results — Conventional Units
Reagent: CHOL0 Reagent volume: 240 о General о Calibration о SmartWash ● Results о Interpretation
Diluent: Saline Water volume: ___ Assay: Chol Result units: mg/dL
Diluent dispense mode: Type 0 Dispense mode: Type 0 Assay defaults:
Diluted Default Low-Linearity: 7†
Dilution name Sample sample Diluent Water Dilution factor dilution High-Linearity: 705
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● Gender and age specific ranges:
1:4 : 25.0 2.4 75 ___ = 1:4.00 о GENDER AGE (UNITS) NORMAL EXTREME
_________ : ___ ___ ___ ___ = о Either 0 – 130 (Y) 0 – 199

о Reaction definition о Reagent / Sample ● Validity checks

Reaction check: None
Configure result units — Conventional Units
Assay: Chol
Version: 1
Maximum absorbance variation: ___ Result units: mg/dL
Decimal places: 0 [Range 0 – 4]
Correlation factor: 1.0000
Configure assay parameters — Calibration
Intercept: 0.0000
о General ● Calibration о SmartWash о Results о Interpretation
Assay: Chol Calibration method: Linear

● Calibrators о Volumes о Intervals о Validity checks Cholesterol Serum/Plasma—SI Units

Calibrator set: Calibrator level: Concentration:
MCC Blank: Water 0†† Configure assay parameters — Results — SI Units
Cal 1: MCC1 ‡ о General о Calibration о SmartWash ● Results о Interpretation
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ Assay: Chol Result units: mmol/L
Assay defaults:
о Calibrators ● Volumes о Intervals о Validity checks Low-Linearity: 0.17†
Calibrator: MCC High-Linearity: 18.26
Diluted
Calibrator level Sample sample Diluent Water Gender and age specific ranges:
Blank: Water 2.4 ___ ___ ___ GENDER AGE (UNITS) NORMAL EXTREME
Cal 1: MCC1 2.4 ___ ___ ___ Either 0 – 130 (Y) 0.00 – 5.17
Cal 2: MCC2 2.4 ___ ___ ___

о Calibrators о Volumes ● Intervals о Validity checks Configure result units — SI Units

Calibration intervals:
Full interval: 720 (hours) Assay: Chol
Calibration type: Version: 1
Adjust type: None Result units: mmol/L
Decimal places: 2 [Range 0 – 4]
о Calibrators о Volumes о Intervals ● Validity checks Correlation factor: 1.0000
Blank absorbance range: _____ – _____ Intercept: 0.0000
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
‡ Refer to concentration specified on calibrator labeling or value sheet.
†† Displays the number of decimal places defined in the decimal places parameter field.

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AEROSET SYSTEM ASSAY PARAMETERS

Cholesterol Serum/Plasma—Conventional Units Cholesterol Serum/Plasma—SI Units

Assay Configuration: Outline Page Assay Configuration: Outline Page

Assay Name Assay # Line Assay Name Assay # Line
Chol 18 B-Line Chol 18 B-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 0 199 0.0 0.0* * * 0.0* 0.0 0.00 5.17 0.0 0.0* *
7** L-Linear Range-H 705 0.17** L-Linear Range-H 18.26
Reference Ranges* Reference Ranges*
Age Male Female Age Male Female
0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0
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 500 / 660 31 – 33 / 0 – 0 0.0 END UP 500 / 660 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
_____ ( ___ ) 0–0 0–0 0.0 – 0.0 _____ ( ___ ) 0–0 0–0 0.0 – 0.0
S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol
Standard 2.4 0.0 0 0 Rgt Name/Pos Standard 2.4 0.0 0 0 Rgt Name/Pos
Dil 1 25.0 2.4 75 0 Diluent: DILUENT D–18* Dil 1 25.0 2.4 75 0 Diluent: DILUENT D–18*
Dil 2 2.4 0.0 0 0 Type# 0 Dil 2 2.4 0.0 0 0 Type# 0
Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type#
Reagent 1 CHOL061 – ___* 240 0 0 Reagent 1 CHOL061 – ___* 240 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 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

Calib Mode Interval (H) Calib Mode Interval (H)
Linear 720 Linear 720
Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range
3/3 0 BLK – 1 0.0 – 0.0 3/3 0 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 2.4 0.0 0 0 0.0 – 0.0 BLK Water 2.4 0.0 0 0 0.0 – 0.0
C1 MCC 1 2.4 0.0 0 0 Cal Deviation C1 MCC 1 2.4 0.0 0 0 Cal Deviation
C2 MCC 2 2.4 0.0 0 0 0.0 C2 MCC 2 2.4 0.0 0 0 0.0
FAC Limit (%) FAC Limit (%)
10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page

Rgt Probe Rgt Probe
Reagent Wash Vol Reagent Wash Vol
ALBP061 Water 300 ALBP061 Water 300
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.
** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

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