Catalog Number: 05167035190
AMY-P: ACN 8571
In vitro test for the quantitative determination of pancreatic α-amylase in human serum, plasma and urine on Roche/Hitachi cobas c systems.
cobas c 701/702 test definition
Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.
|Calibrators||S1: H2OS2: C.f.a.s.|
|Calibration frequency||2-point calibration- after reagent lot change- as required following quality control procedures|
Serum, plasma and urine
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:
Pancreatic amylase values for human serum, plasma and urine samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the same reagent on a Roche/Hitachi cobas c 501 analyzer (x).