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- AFTER REAGENT LOT CHANGE- AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

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.

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 corresponding 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,PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.