α-Amylase EPS ver.2

Catalog Number: 05167027190

SYSTEM INFORMATION

AMYL2: ACN 8570

INTENDED USE

In vitro test for the quantitative determination of α-amylase in human serum, plasma and urine on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

AMYL2
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours
Diluent NaCl 9 %
Shelf life at 2-8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 4 weeks
On-board on the Reagent Manager: 24 hours

APPLICATION FOR SERUM, PLASMA AND URINE

cobas c 701/702 test definition

CALIBRATION

Traceability: This method has been standardized against Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and substrate-specific absorptivity, ε.

Calibrators S1: H2OS2: C.f.a.s.
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

Serum/plasma/urine

LOWER LIMITS OF MEASUREMENT

Lower detection limit:

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

INTERMEDIATE PRECISION

METHOD COMPARISON

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).