Triglycerides

Catalog Number: 20767107322

SYSTEM INFORMATION

Test TRIGL, test ID 0‑010

INTENDED USE

In vitro test for the quantitative determination of the triglycerides concentration in human serum and plasma on COBAS INTEGRA systems.

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R-S
Reaction direction Increase
Wavelength A/B 512/659 nm
Calc. first/last 17/42
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R 120 µL
Sample 2 µL 28 µL
Total volume 150 µL

  Diluent (H2O)
R 120 µL
Sample 2 µL 28 µL
Total volume 150 µL

COBAS INTEGRA 800 test definition

Calibration

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R-S
Reaction direction Increase
Wavelength A/B 512/659 nm
Calc. first/last 17/60
Unit mmol/L

Pipetting parameters

PIPETTING PARAMETERS

  Diluent (H2O)
R 120 µL
Sample 2 µL 28 µL
Total volume 150 µL

Calibration

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrator Calibrator f.a.s.Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.1‑10 mmol/L (8.85‑885 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:0.1 mmol/L (8.85 mg/dL)

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 20 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

Triglycerides values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer using the COBAS INTEGRA Triglycerides (TRIGL) reagent (y) were compared with those determined using commercially available reagents for triglycerides on a COBAS INTEGRA 700 analyzer (COBAS INTEGRA TRIG reagent) (x) and an alternative manufacturer’s clinical chemistry system (x). Samples were measured in duplicate. Sample size (n) represents all replicates.

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.