CHOLESTEROL

List No. 7D62-20

30-3059/R2

CHOLESTEROL

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This package insert contains information to run the Cholesterol assay on the AEROSET System and the

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ARCHITECT® c8000 System.

NOTE: Changes to AEROSET System Information Highlighted

(Supplemental and format changes are not highlighted)
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NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed
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accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this
package insert.
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Customer Support
United States: 1-800-527-1869
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Canada: 1-800-387-8378 (English speaking customers)

1-800-465-2675 (French speaking customers)
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International: Call your local Abbott representative

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Symbols in Product Labeling

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Authorized Representative Consult instructions for use

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IVD For in vitro diagnostic use Legal Manufacturer

LOT Batch code/Lot number Temperature limitation

R1 Reagent 1 Use by/Expiration date

REF Catalog number/List number

SN Serial number

ABBOTT
ABBOTT LABORATORIES
Max-Planck-Ring 2
Abbott Park, IL 60064, USA
65205 Wiesbaden
Germany
+49-6122-580
January 2003
ABBOTT LABORATORIES, Diagnostics Division Printed in U.S.A.
Abbott Park, Illinois 60064 ©2002, 2003 Abbott Laboratories

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NAME
CHOLESTEROL

INTENDED USE
The Cholesterol assay is used for the quantitation of cholesterol in human serum or plasma.

SUMMARY AND EXPLANATION OF TEST

Measurement of serum cholesterol levels can serve as an indicator of liver function, biliary function, intestinal absorption, propensity toward coronary
artery disease, and thyroid function. Cholesterol levels are important in the diagnosis and classification of hyperlipoproteinemias. Stress, age, gender,
hormonal balance, and pregnancy affect normal cholesterol levels.1
The Adult Treatment Panel of the National Cholesterol Education Program (NCEP) recommends that all adults 20 years of age and over should have a
fasting lipoprotein profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) once every five years to screen for coronary heart
disease risk.2

PRINCIPLES OF PROCEDURE
The use of enzymes to assay cholesterol has been studied by many investigators.3, 4 This reagent is based on the formulation of Allain, et al.5 and the
modification of Roeschlau6 with further improvements to render the reagent stable in solution.
Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally

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present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide combines with Hydroxybenzoic
Acid (HBA) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 500 nm.

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REAGENTS

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Reagent Kit
Cholesterol, List No. 7D62, is supplied as a liquid, ready-to-use, single reagent kit which contains:
• Reagent 1 (R1) 10 x 84 mL

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Estimated tests per kit are 3,032. Calculation based on minimum reagent fill volume per kit.

Reactive Ingredients

Ingredient

Cholesterol Oxidase (Microbial)

Concentration

> 200 U/L U

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Cholesterol Esterase (Microbial) > 500 U/L
Peroxidase (Horseradish) > 300 U/L
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4-Aminoantipyrine 0.25 mmol/L

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HBA 10 mmol/L

The Abbott Clinical Chemistry Cholesterol reagent is certified to be traceable to the National Reference System for Cholesterol, against the
Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN).
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REAGENT HANDLING AND STORAGE

Reagent Handling
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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
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impact results.

Reagent Storage
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The unopened reagents are stable until the expiration date when stored at 2 to 8°C.
Reagent stability is 30 days if the reagent is uncapped and onboard.
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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. Contains nonsterile bovine serum albumin.
Information for European customers: For reagents not classified as dangerous per European Directive 1999/45/EC, safety data sheet available for
professional user on request.

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SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum and plasma are acceptable specimens. The National Cholesterol Education Program (NCEP) recommends using fasting specimens.2
Serum: Use serum with or without gel barrier collected by standard venipuncture techniques in glass or plastic tubes. Ensure complete clot formation
has taken place prior to centrifugation. Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy, may exhibit
increased clotting time. If the specimen is centrifuged before a complete clot forms, the presence of fibrin may cause erroneous results. Separate from
red blood cells as soon after collection as possible.
Plasma: Use plasma without gel barrier (acceptable anticoagulants: lithium heparin, ammonium heparin, and sodium heparin) collected by standard
venipuncture techniques in glass or plastic tubes. Ensure centrifugation is adequate to remove platelets. Separate from red blood cells as soon after
collection as possible.
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.
CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials are considered potentially
infectious and be handled in accordance with the OSHA Standard on Bloodborne Pathogens.7 Biosafety Level 28 or other appropriate biosafety
practices9, 10 should be used for materials that contain or are suspected of containing infectious agents.

Specimen Storage
Serum and plasma:

Temperature Maximum Storage Reference

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20 to 25°C 7 days 11
2 to 8°C 7 days 11, 12

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-20°C 3 months 11

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Guder et al.11 suggest storage of frozen specimens at -20°C for no longer than the time intervals 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 the laboratory Standard Operating Procedure(s) for specimen storage.

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NOTE: Stored specimens must be adequately mixed prior to testing.

PROCEDURE
Materials Provided
Cholesterol Reagent Kit, List No. 7D62 U
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Materials Required but not Provided
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• AEROSET System or ARCHITECT c8000 System
• Multiconstituent Calibrator, List No. 1E65
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CAL 1: 3 x 5 mL
CAL 2: 3 x 5 mL
• Control Material
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• Saline (0.85 to 0.90%), if desired for specimen dilution

Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of the instrument-specific operations manual.
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Specimen Dilution Procedures

Use saline to dilute samples outside of the linearity of the assay. The AEROSET System and the ARCHITECT c8000 System have Automatic Dilution
features; refer to Section 2 of the instrument-specific operations manual for additional information.
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CALIBRATION
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Calibration is stable for approximately 30 days (720 hours) and calibration is required with each lot number change. Verify calibration curve with at least
two levels of controls according to the established Quality Control requirements for your laboratory. If control results fall outside acceptable ranges,
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recalibration may be necessary.

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 Multiconstituent Calibrator package insert.

QUALITY CONTROL
The following process is the recommendation of Abbott Laboratories for quality control during the Cholesterol procedure. As appropriate, refer to your
laboratory Standard Operating Procedure(s) and/or Quality Assurance Plan for additional quality control requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every 24 hours.
• If more frequent control monitoring is required, follow the established Quality Control procedures for your laboratory.
• If quality control results do not fall within an acceptable range defined by your laboratory, patient values may be suspect. Follow the established
Quality Control procedures for your laboratory.
• If quality control results fall outside acceptance criteria, recalibration may be necessary.
• Review quality control results and acceptance criteria following a change of reagent or calibrator lot.

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RESULTS
Refer to the instrument-specific operations manual for information on results calculations.
• AEROSET System Operations Manual—Appendix A
• ARCHITECT System Operations Manual—Appendix C

LIMITATIONS OF THE PROCEDURE

Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert.

EXPECTED VALUES
Reference Range
Serum/Plasma

Range (mg/dL) Range (mmol/L)

Child13
Desirable 쏝 170 쏝 4.40
Borderline 170 to 199 4.40 to 5.15
High 욷 200 욷 5.18

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Adult2
Desirable 쏝 200 쏝 5.18

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Borderline 200 to 239 5.18 to 6.19
High 욷 240 욷 6.22

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To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0259.

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The National Cholesterol Education Program (NCEP) Adult Treatment Panel III Report2 recommends the adult classification shown above. Laboratories
should follow recommendations for lipid ranges effective in their locale if they differ from those of the NCEP.

SPECIFIC PERFORMANCE CHARACTERISTICS

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Linearity
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Cholesterol is linear up to 705 mg/dL (18.26 mmol/L).

Linearity was verified using NCCLS protocol EP6-P.14
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Limit of Detection (LOD)

The LOD is the mean concentration of an analyte-free sample + 2 SD, where SD = the pooled, within-run standard deviation of the analyte-free sample.
The LOD for Cholesterol is 0.8 mg/dL (0.021 mmol/L).
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Limit of Quantitation (LOQ)

The LOQ is the analyte concentration at which the CV = 20%. The limit of quantitation for Cholesterol is 6.2 mg/dL (0.161 mmol/L).
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Interfering Substances15
Interference studies were conducted on the AEROSET System using NCCLS protocol EP7-P.16 Interference effects were assessed by Dose Response
and Paired Difference methods, at the medical decision level of the analyte concentration or activity.
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Interfering Interferent Concentration N Target Observed

Substance (mg/dL) (% of Target)
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Bilirubin 7.5 mg/dL (128 µmol/L) 4 252.3 91.7

Bilirubin 15 mg/dL (257 µmol/L) 4 252.3 86.8
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Hemoglobin 750 mg/dL (7.5 g/L) 4 241.1 109.5

Hemoglobin 1,000 mg/dL (10.0 g/L) 4 241.1 111.9
Intralipid 1,000 mg/dL (10.0 g/L) 4 236.1 102.5
Intralipid 2,000 mg/dL (20.0 g/L) 4 236.1 101.9
Ascorbate 1.5 mg/dL (85 µmol/L) 4 282.2 98.7
Ascorbate 3 mg/dL (170 µmol/L) 4 282.2 97.6

Bilirubin levels were prepared by the addition of a bilirubin stock to human serum pools. Hemoglobin levels were prepared by addition of hemolysate to
human serum pools. Intralipid levels were prepared by addition of Intralipid to human serum pools. Ascorbate levels were prepared by addition of
ascorbic acid to human serum pools.

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SPECIFIC PERFORMANCE CHARACTERISTICS (Continued)

Precision
The results from precision studies for serum using NCCLS protocol EP5-T217 are found below.

Control N Mean Within Run Between Run Between Day Total

(mg/dL) SD %CV SD %CV SD %CV SD %CV

Level 1 80 268.5 1.84 0.7 0.77 0.3 0.98 0.4 2.23 0.8
Level 2 80 129.9 1.25 1.0 0.71 0.5 1.55 1.2 2.11 1.6

Method Comparison
Correlation studies were performed using NCCLS protocol EP9-A.18 Serum results from the Cholesterol assay on the AEROSET System were
compared with the Boehringer Mannheim Cholesterol assay (enzymatic methodology) on the Hitachi 717 Analyzer. Serum results observed on the
AEROSET System ranged from 70.6 to 416.8 mg/dL.
Serum

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Y - Intercept 0.933
Correlation Coefficient 0.993
Slope 1.016

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Number of Samples 79

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SPECIFIC PERFORMANCE CHARACTERISTICS (Continued)

Precision
The results from precision studies for serum using NCCLS protocol EP5-A19 are found below.

Control N Mean Within Run Between Run Between Day Total

(mg/dL) SD %CV SD %CV SD %CV SD %CV

Level 1
Instrument 1 80 263.2 1.45 0.6 0.65 0.3 2.23 0.9 2.74 1.0
Instrument 2 80 261.4 1.98 0.8 1.01 0.4 3.36 1.3 4.03 1.5
Instrument 3 80 264.2 0.88 0.3 2.48 0.9 2.30 0.9 3.49 1.3

Level 2
Instrument 1 80 127.7 0.59 0.5 0.96 0.8 1.46 1.1 1.84 1.4
Instrument 2 80 127.5 0.78 0.6 0.89 0.7 1.23 1.0 1.70 1.3
Instrument 3 80 129.2 0.78 0.6 1.03 0.8 1.64 1.3 2.09 1.6

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Method Comparison
Correlation studies were performed based on NCCLS protocol EP9-A.18 Serum results from the Cholesterol assay on the ARCHITECT c8000 System

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were compared with the Cholesterol assay on the AEROSET System. Serum results observed on the AEROSET System ranged from
39.5 to 687.6 mg/dL.

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Instrument 1 Instrument 2 Instrument 3

Y - Intercept -0.997 -0.840 -0.266

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Correlation Coefficient 0.994 0.993 0.994
Slope 0.994 0.979 0.984
Number of Samples 101 101 101

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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
0.0 – 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 Year
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
Qualitative Ranges N/A Qualitative Ranges N/A

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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

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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

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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

Reagent 1
2.4 0.0
Rgt Name/Pos
CHOL061 – ___*
0
R.Vol
240
0
W.Vol
0
Type#*** 0
Type#***
0 U
Dil 2

Reagent 1
2.4 0.0
Rgt Name/Pos
CHOL061 – ___*
0
R.Vol
240
0
W.Vol
0
Type#*** 0
Type#***
0
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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
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Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units

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1.0 / 0.0 0 mg/dL 1.0 / 0.0 2 mmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page

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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
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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
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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
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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.
*** This field is not available with AEROSET Software v1.00ER005 or 1.00ER005.2.

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ARCHITECT c8000 SYSTEM ASSAY PARAMETERS

Cholesterol Serum/Plasma—Conventional and SI Units

Configure assay parameters – General Configure assay parameters – SmartWash
쎲 General 쑗 Calibration 쑗 SmartWash 쑗 Results 쑗 Interpretation 쑗 General 쑗 Calibration 쎲 SmartWash 쑗 Results 쑗 Interpretation
Assay: Chol Type: Photometric Version: 1 Assay: Chol
Number: 1018
COMPONENT REAGENT / ASSAY WASH Volume Replicates
쎲 Reaction definition 쑗 Reagent / Sample 쑗 Validity checks R1 ALBP0 Water 300 1
Reaction mode: End up Cuvette Trig Detergent B 345
Primary Secondary Read times
Wavelength: 500 / 660 Main: 31 – 33
Last required read: 33
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: None Cholesterol Serum/Plasma—Conventional Units
Configure assay parameters – Results – Conventional units
쑗 Reaction definition 쎲 Reagent / Sample 쑗 Validity checks 쑗 General 쑗 Calibration 쑗 SmartWash 쎲 Results 쑗 Interpretation

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R1 Assay: Chol Result units: mg/dL
Reagent: CHOL0 Reagent volume: 240 Assay defaults:
Diluent: Saline Water volume: ___ Low-Linearity: 7†

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Diluent dispense mode: Type 0 Dispense mode: Type 0 High-Linearity: 705
Diluted Default Gender and age specific ranges:

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Dilution name Sample sample Diluent Water Dilution factor dilution
GENDER AGE (UNITS) NORMAL EXTREME
STANDARD : 2.4 ___ ___ ___ = 1:1.00 쎲 Either 0 – 130 (Y) 0 – 199
1:4 : 25.0 2.4 75 ___ = 1:4.00 쑗

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________ : ___ ___ ___ ___ = 쑗

쑗 Reaction definition 쑗 Reagent / Sample 쎲 Validity checks

Reaction check: None
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Configure result units – Conventional units
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Maximum absorbance variation: ___ Assay: Chol
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Version: 1
Result units: mg/dL
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Decimal places: 0 [Range 0 – 4]

Configure assay parameters – Calibration Correlation factor: 1.000
쑗 General 쎲 Calibration 쑗 SmartWash 쑗 Results 쑗 Interpretation Intercept: 0.000
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Assay: Chol Calibration method: Linear

쎲 Calibrators 쑗 Volumes 쑗 Intervals 쑗 Validity checks Cholesterol Serum/Plasma—SI Units

Calibrator set: Calibrator level: Concentration:
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Configure assay parameters – Results – SI units

MCC Blank: Water 0††
Cal 1: MCC1 ‡ 쑗 General 쑗 Calibration 쑗 SmartWash 쎲 Results 쑗 Interpretation
Replicates: 3 [Range 1 – 3] Cal 2: MCC2 ‡ Assay: Chol Result units: mmol/L
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Assay defaults:
쑗 Calibrators 쎲 Volumes 쑗 Intervals 쑗 Validity checks Low-Linearity: 0.17†
High-Linearity: 18.26
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Calibrator: MCC Diluted Gender and age specific ranges:

Calibrator level Sample sample Diluent Water
GENDER AGE (UNITS) NORMAL EXTREME
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Blank: Water 2.4 ___ ___ ___

Either 0 – 130 (Y) 0.00 – 5.17
Cal 1: MCC1 2.4 ___ ___ ___
Cal 2: MCC2 2.4 ___ ___ ___

쑗 Calibrators 쑗 Volumes 쎲 Intervals 쑗 Validity checks

Calibration intervals:
Full interval: 720 (hours)
Calibration type: Configure result units – SI units
Adjust type: None Assay: Chol
Version: 1
쑗 Calibrators 쑗 Volumes 쑗 Intervals 쎲 Validity checks Result units: mmol/L
Decimal places: 2 [Range 0 – 4]
Blank absorbance range: _____ – _____
Span: Blank – Water Correlation factor: 1.000
Span absorbance range: _____ – _____ Intercept: 0.000
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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BIBLIOGRAPHY
1. Burtis CA, Ashwood ER, eds. 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; final rule. Federal Register 1991;56(235):64175–82.
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, 1993.
10. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline—Second Edition (M29-A2). Wayne, PA: National Committee for Clinical Laboratory Standards, 2001.
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.

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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:

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The National Committee for Clinical Laboratory Standards, 1986.

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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.

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17. 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.
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.
19.
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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.
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TRADEMARKS
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AEROSET and ARCHITECT are registered trademarks of Abbott Laboratories.

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c8000 is a trademark of Abbott Laboratories.

All other trademarks, brands, product names, and trade names are the property of their respective companies.
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