Fructosamine

Catalog Number: 05171962190

SYSTEM INFORMATION

FRA: ACN 8667

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

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition
Assay type Rate A
Reaction time / Assay points 10/34-38
Wavelength (sub/main) 700/546 nm
Reaction direction Increase
Unit µmol/L
Reagent pipetting Diluent (H2O)
R1 60 µL 28 µL
R3 12 µL 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (H2O)
Normal 6 µL
Decreased 3 µL
Increased 12 µL

Calibration

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 4 weeks on board - 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

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).

INTERMEDIATE PRECISION

METHOD COMPARISON

Fructosamine values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined on Roche/Hitachi cobas c 501 analyzers (x).

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.