Albumin BCP

Catalog Number: 05975573190

SYSTEM INFORMATION

ALBP: ACN 8760

INTENDED USE

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

STORAGE AND STABILITY

ALBP
Shelf life at 15‑25 °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

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition

CALIBRATION

Traceability: This method has been standardized against the ERM‑DA470k/IFCC reference preparation.

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

2‑100 g/L (30.4‑1520 µmol/L)

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

METHOD COMPARISON

Albumin values for human serum and plasma 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,