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Triglyceride ARC CHEM
Triglyceride ARC CHEM
7D74-20
30-3140/R3
TRIGLYCERIDE
This package insert contains information to run the Triglyceride 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
Reagent 1
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NAME REAGENT HANDLING AND STORAGE
TRIGLYCERIDE Reagent Handling
Remove air bubbles, if present in the reagent cartridge, with a new
INTENDED USE applicator stick. Alternatively, allow the reagent to sit at the appropriate
The Triglyceride assay is used for the quantitation of triglyceride in storage temperature to allow the bubbles to dissipate. To minimize
human serum or plasma. volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Reagent bubbles may interfere with proper detection of
SUMMARY AND EXPLANATION OF TEST reagent level in the cartridge, causing insufficient reagent aspiration
Triglycerides are a family of lipids absorbed from the diet and produced which could impact results.
endogenously from carbohydrates and fatty acids. Measurement
of triglyceride is important in the diagnosis and management of Reagent Storage
hyperlipidemia. These diseases can be genetic or secondary to Unopened reagents are stable until the expiration date when stored
other disorders including nephrosis, diabetes mellitus, and endocrine at 2 to 8°C.
disturbances. The National Cholesterol Education Program (NCEP) Reagent stability is 42 days if the reagent is uncapped and onboard.
cites evidence that triglycerides are an independent risk factor for
atherosclerosis.1 Individuals with hypertension, obesity, and/or diabetes WARNINGS AND PRECAUTIONS
are at greater risk than are those without these conditions.2,3
The Adult Treatment Panel of the NCEP recommends that all adults Precautions for Users
20 years of age and over should have a fasting lipoprotein profile (total 1. For in vitro diagnostic use.
cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride) once 2. Do not use components beyond the expiration date.
every five years to screen for coronary heart disease risk.1 3. Do not mix materials from different kit lot numbers.
4. Certain disease states may cause endogenous serum triglyceride
PRINCIPLES OF PROCEDURE values to be grossly elevated. Samples that are grossly lipemic by
Triglycerides are enzymatically hydrolyzed by lipase to free fatty acids visual examination should be diluted prior to analysis.
and glycerol. The glycerol is phosphorylated by adenosine triphosphate 5. CAUTION: This product requires the handling of human specimens.
(ATP) with glycerol kinase (GK) to produce glycerol-3-phosphate and It is recommended that all human sourced materials be considered
adenosine diphosphate (ADP). Glycerol-3-phosphate is oxidized to potentially infectious and handled in accordance with the OSHA
dihydroxyacetone phosphate (DAP) by glycerol phosphate oxidase Standard on Bloodborne Pathogens.6 Biosafety Level 27 or other
(GPO) producing hydrogen peroxide (H2O2). In a color reaction appropriate biosafety practices8,9 should be used for materials that
catalyzed by peroxidase, the H2O2 reacts with 4-aminoantipyrine contain or are suspected of containing infectious agents.
(4-AAP) and 4-chlorophenol (4-CP) to produce a red colored dye. The
absorbance of this dye is proportional to the concentration of triglyceride SPECIMEN COLLECTION AND HANDLING
present in the sample. This analytical methodology is based on the
reaction sequence described by Fossati et al.4 and by McGowan et al.5 Suitable Specimens
In this reagent, 4-chlorophenol is used rather than 2-hydroxy-3,5-dichlor- Serum and plasma are acceptable specimens. The National Cholesterol
obenzenesulfonate, used in the Fossati and McGowan studies. Education Program (NCEP) recommends using fasting specimens.1
Methodology: Glycerol Phosphate Oxidase • Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
REAGENTS complete clot formation has taken place prior to centrifugation.
Separate serum from red blood cells or gel as soon after collection
Reagent Kit as possible.
7D74 Triglyceride is supplied as a liquid, ready-to-use, single Some specimens, especially those from patients receiving
reagent kit which contains: anticoagulant or thrombolytic therapy, may take longer to complete
10 x 84 mL their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
Estimated tests per kit: 3,032
• Plasma: Use plasma collected by standard venipuncture techniques
Calculation is based on the minimum reagent fill volume per kit. into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin (with or without gel barrier) and sodium heparin. Ensure
Reactive Ingredients Concentration centrifugation is adequate to remove platelets. Separate plasma from
ATP 2.5 mmol/L red blood cells or gel as soon after collection as possible.
Mg2+ 2.5 mmol/L
Refer to the specimen collection tube manufacturer’s instructions for
4-Aminoantipyrine 0.4 mmol/L processing and handling requirements.
4-Chlorophenol 2 mmol/L
For total sample volume requirements, refer to the instrument-specific
Peroxidase (Horseradish) > 2,000 U/L ASSAY PARAMETERS section of this package insert and Section 5 of
GK (Microbial) > 600 U/L the instrument-specific operations manual.
GPO (Microbial) > 6,000 U/L
Lipoprotein Lipase (Microbial) > 3,000 U/L
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SPECIMEN COLLECTION AND HANDLING (Continued) QUALITY CONTROL
Specimen Storage The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
Serum and plasma procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
Temperature Maximum Bibliographic
• Two levels of controls (normal and abnormal) are to be run every
Storage Reference
24 hours.
20 to 25°C 2 days 10 • If more frequent control monitoring is required, follow the established
2 to 8°C 7 days 10, 11 quality control procedures for your laboratory.
-20°C > 1 year 10 • If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
Guder et al.10 suggest storage of frozen specimens at -20°C for the established quality control procedures for your laboratory.
no longer than the time interval cited above. However, limitations Recalibration may be necessary.
of laboratory equipment make it necessary in practice for clinical
laboratories to establish a range around -20°C for specimen storage. • Review quality control results and acceptance criteria following a
This temperature range may be established from either the freezer change of reagent or calibrator lot.
manufacturer’s specifications or your laboratory standard operating
procedure(s) for specimen storage. RESULTS
Refer to the instrument-specific operations manual for information on
NOTE: Stored specimens must be inspected for particulates. If present,
results calculations.
mix and centrifuge the specimen to remove particulates prior to testing.
• ARCHITECT System Operations Manual—Appendix C
PROCEDURE • AEROSET System Operations Manual—Appendix A
Representative performance data are given in the EXPECTED VALUES
Materials Provided and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
7D74 Triglyceride Reagent Kit package insert. Results obtained in individual laboratories may vary.
Materials Required but not Provided
• 1E65 Multiconstituent Calibrator, 3 x 5 mL LIMITATIONS OF THE PROCEDURE
• Control Material Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
• Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Assay Procedure EXPECTED VALUES
For a detailed description of how to run an assay, refer to Section 5 of Reference Range
the instrument-specific operations manual.
Serum/Plasma1
Specimen Dilution Procedures
The ARCHITECT c Systems and the AEROSET System have automatic Range (mg/dL) Range (mmol/L)
dilution features; refer to Section 2 of the instrument-specific operations Normal < 150 < 1.70
manual for additional information. Borderline High 150 to 199 1.70 to 2.25
Serum and plasma: Specimens with triglyceride values exceeding High 200 to 499 2.26 to 5.64
1,420 mg/dL (16.05 mmol/L) are flagged and may be diluted using the Very High ≥ 500 ≥ 5.65
Automated Dilution Protocol or the Manual Dilution Procedure.
Automated Dilution Protocol To convert results from mg/dL to mmol/L, multiply mg/dL by 0.0113.
If using the Automated Dilution Protocol, the system performs a 1:4 The National Cholesterol Education Program (NCEP) Adult Treatment
dilution of the specimen and automatically corrects the concentration by Panel III Report recommends the classification shown above.
multiplying the result by the appropriate dilution factor. Laboratories should follow recommendations for lipid ranges effective in
their locale if they differ from those of the NCEP.
Manual Dilution Procedure
Manual dilutions should be performed as follows: SPECIFIC PERFORMANCE CHARACTERISTICS
• Use saline (0.85% to 0.90% NaCl) to dilute the sample. Linearity
• The operator must enter the dilution factor in the patient or control Triglyceride is linear up to 1,420 mg/dL (16.05 mmol/L). Linearity was
order screen. The system uses this dilution factor to automatically verified using Clinical and Laboratory Standards Institute (CLSI) protocol
correct the concentration by multiplying the result by the entered NCCLS EP6-P.12
factor.
• If the operator does not enter the dilution factor, the result must be Limit of Detection (LOD)
multiplied by the appropriate dilution factor before reporting the result. The LOD for Triglyceride is 5.0 mg/dL (0.06 mmol/L). The LOD is
NOTE: If a diluted sample result is flagged indicating it is less than the the mean concentration of an analyte-free sample + 2 SD, where
linear low limit, do not report the result. Rerun using an appropriate SD = the pooled, within-run standard deviation of the analyte-free
dilution. sample. A study performed on an ARCHITECT c System and an
For detailed information on ordering dilutions, refer to Section 5 of the AEROSET System produced an LOD for the Triglyceride assay
instrument-specific operations manual. of 1.00 mg/dL (0.012 mmol/L).
Limit of Quantitation (LOQ)
CALIBRATION The LOQ for Triglyceride is 6.2 mg/dL (0.071 mmol/L). The LOQ is
Calibration is stable for approximately 41 days (984 hours) and is the analyte concentration at which the CV = 20%.
required with each change in reagent lot number. Verify calibration with
at least two levels of controls according to the established quality control
requirements for your laboratory. If control results fall outside acceptable
ranges, 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.
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SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY
(Continued) 1. Executive summary of the third report of the National Cholesterol
Education Program (NCEP) Expert Panel on detection, evaluation,
Interfering Substances13 and treatment of high blood cholesterol in adults (Adult Treatment
Interference studies were conducted using CLSI protocol NCCLS Panel III). JAMA 2001;285:2486–97.
EP7-P.14 Interference effects were assessed by Dose Response and
2. Rubins HB. Triglycerides and coronary heart disease: implications
Paired Difference methods, at the medical decision level of the analyte.
of recent clinical trials. J Cardiovasc Risk 2000;7(5):339–45.
Interfering Interferent Concentration N Target Observed 3. Forrester JS. Triglycerides: risk factor or fellow traveler? Curr Opin
Substance (mg/dL) (% of Target) Cardiol 2001;16:261–4.
7.5 mg/dL (128 µmol/L) 3 211.0 106.6 4. Fossati P, Prencipe L. Serum triglycerides determined
Bilirubin colorimetrically with an enzyme that produces hydrogen peroxide.
15 mg/dL (257 µmol/L) 3 211.0 111.3
Clin Chem 1982;28:2077–80.
750 mg/dL (7.5 g/L) 4 193.1 109.6
Hemoglobin 5. McGowan MW, Artiss JD, Strandbergh DR, et al. A
1,000 mg/dL (10.0 g/L) 4 193.1 111.2 peroxidase-coupled method for the colorimetric determination of
1.5 mg/dL (85 µmol/L) 4 220.4 97.0 serum triglycerides. Clin Chem 1983;29:538–42.
Ascorbate
3.0 mg/dL (170 µmol/L) 4 220.4 94.0 6. US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030, Occupational exposure to
Bilirubin solutions at the above concentrations were prepared by addition bloodborne pathogens.
of a bilirubin stock to human serum pools. Hemoglobin solutions at the
above concentrations were prepared by addition of hemolysate to human 7. US Department of Health and Human Services. Biosafety in
serum pools. Ascorbate solutions at the above concentrations were Microbiological and Biomedical Laboratories. HHS Publication
prepared by addition of ascorbic acid to human serum pools. (CDC), 4th ed. Washington, DC: US Government Printing Office,
May 1999.
Precision 8. World Health Organization. Laboratory Biosafety Manual. Geneva:
The imprecision of the Triglyceride assay is ≤ 5% Total CV. World Health Organization, 2004.
Representative data from studies using CLSI protocol NCCLS EP5-A15 9. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
are summarized below. Workers from Occupationally Acquired Infections; Approved
Control Level 1 Level 2 Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
N 80 80
10. Guder WG, Narayanan S, Wisser H, et al. List of
Mean (mg/dL) 209.4 100.0 analytes—preanalytical variables. Annex In: Samples: From
SD 1.42 0.80 the Patient to the Laboratory. Darmstadt, Germany: GIT Verlag;
Within Run
%CV 0.7 0.8 1996:Annex 22–3.
SD 0.75 0.64 11. US Pharmacopeial Convention, Inc. General notices. In: US
Between Run Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
%CV 0.4 0.6
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
SD 3.25 1.67
Between Day 12. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
%CV 1.6 1.7 of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
SD 3.63 1.96 Villanova, PA: The National Committee for Clinical Laboratory
Total Standards, 1986.
%CV 1.7 2.0
13. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Method Comparison Washington, DC: AACC Press; 1995:3-573–3-589.
Correlation studies were performed using CLSI protocol NCCLS 14. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in
EP9-A.16 Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The
Serum results from the Triglyceride assay on the AEROSET System National Committee for Clinical Laboratory Standards, 1986.
were compared with those from a commercially available glycerol 15. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
phosphate oxidase methodology. Performance of Clinical Chemistry Devices; Approved Guideline
Serum results from the Triglyceride assay on an ARCHITECT c System (EP5-A). Wayne, PA: The National Committee for Clinical
were compared with the Triglyceride assay on an AEROSET System. Laboratory Standards, 1999.
16. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
AEROSET ARCHITECT and Bias Estimation Using Patient Samples; Approved Guideline
vs. Comparative vs. AEROSET (EP9-A). Wayne, PA: The National Committee for Clinical
Method Laboratory Standards, 1995.
N 76 91
Y - Intercept 0.311 5.858
TRADEMARKS
AEROSET and ARCHITECT are registered trademarks of Abbott
Correlation Coefficient 0.994 0.999 Laboratories.
Slope 1.048 0.989 c System is a trademark of Abbott Laboratories.
Range (mg/dL)* 36.1 to 990.6 37.60 to 1,370.40 All other trademarks, brands, product names, and trade names are the
property of their respective companies.
*AEROSET Range
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ARCHITECT c SYSTEMS ASSAY PARAMETERS
о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results
R1 о General о Calibration о SmartWash ● Results о Interpretation
Reagent: TRIG0 Reagent volume: 240 Assay: Trig Result units: mg/dL
Diluent: Saline Water volume: ___ Assay defaults:
Diluent dispense mode: Type 0 Dispense mode: Type 0 Low-Linearity: 7†
Diluted Default High-Linearity: 1420
Dilution name Sample sample Diluent Water Dilution factor dilution Gender and age specific ranges:
STANDARD : 2.4 ___ ___ ___ = 1:1.00 ● GENDER AGE (UNITS) NORMAL EXTREME
1:4 : 25.0 2.4 75 ___ = 1:4.00 о Either 0 – 130 (Y) 0 – 149
__________ : ___ ___ ___ ___ = о
† 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
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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