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.
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 corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).