Triglycerides/Glycerol Blanked

Catalog Numbers: 11877771216, 11877780190, 11877798190

SYSTEM INFORMATION

For Roche/Hitachi MODULAR analyzers: ACN 783

INTENDED USE

In vitro test for the quantitative determination of triglycerides with glycerol blanking in human serum and plasma on Roche automated clinical chemistry analyzers. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, and various endocrine disorders.

STORAGE AND STABILITY

Unopened kit components: up to the expiration date at 2-8 °C

CALIBRATION

Traceability: This method has been standardized against SRM 909b and triolein standards.

CALIBRATION FREQUENCY

RECALIBRATION IS RECOMMENDED:

FULL CALIBRATION DAILY

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/Plasma: 0.05-11.3 mmol/L (4-1000 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

THE LOWER DETECTION LIMIT REPRESENTS THE LOWEST MEASURABLE ANALYTE LEVEL THAT CAN BE DISTINGUISHED FROM ZERO. IT IS CALCULATED AS THE VALUE LYING 3 STANDARD DEVIATIONS ABOVE THAT OF THE LOWEST STANDARD (STANDARD 1 + 3 SD, INTERMEDIATE PRECISION, N = 21).

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

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 (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the TRIG/GB determination using the Roche Diagnostics Trig/GB assay on a Roche/Hitachi 917 analyzer (y) with the same assay on a Roche/Hitachi 717 analyzer (x) gave the following correlation (mg/dL):

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.