Alkaline Phosphatase acc. to IFCC Gen.2

Catalog Number: 03333752190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of alkaline phosphatase in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 ALP2S, ALP2L
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 8 weeks
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: 12 weeks

Specimen collection and preparation

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 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

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

5‑1200 U/L (0.084‑20.0 µkat/L)

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:

METHOD COMPARISON

Alkaline phosphatase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer with the ALP IFCC Gen.2 (ALP2) traceable to IFCC6 method (y), were compared with those determined on the same analyzer with the same ALP2 reagent traceable to IFCC14 method (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.