Catalog Number: 04537939190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

FRA
Shelf life at 2-8 °C:	See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer:	8 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type	Rate A
Reaction time / Assay points	10 / 52-57
Wavelength (sub/main)	700/546 nm
Reaction direction	Increase
Unit	µmol/L

CALIBRATION

Traceability: This method has been standardized against fructose polylysine standard.

Calibrators	S1: H2OS2: Precimat Fructosamine
Calibration mode	Linear
Calibration frequency	2-point calibration• after reagent lot change• as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

14-1000 µmol/L

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

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

Fructosamine values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined on Roche/Hitachi 917/MODULAR P analyzers (x), using the corresponding Roche/Hitachi reagent.

Fructosamine