α-Amylase EPS Pancreatic

Catalog Number: 05167035190

SYSTEM INFORMATION

AMY-P: ACN 8571

INTENDED USE

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

STORAGE AND STABILITY

AMY-P

APPLICATION FOR SERUM, PLASMA AND URINE

cobas c 701/702 test definition

CALIBRATION

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 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 and urine

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

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

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).

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,