Catalog Number: 04537939190
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of glycated proteins (fructosamine) in human serum and plasma on Roche/Hitachi cobas c systems.
|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
|cobas c 311 test definition|
|Assay type||Rate A|
|Reaction time / Assay points||10 / 52-57|
|Wavelength (sub/main)||700/546 nm|
Traceability: This method has been standardized against fructose polylysine standard.
|Calibrators||S1: H2OS2: Precimat Fructosamine|
|Calibration frequency||2-point calibration• after reagent lot change• as required following quality control procedures|
Lower detection limit of the test
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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:
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.