Lactate Gen. 2

Catalog Number: 05171881190

SYSTEM INFORMATION

LACT2: ACN 8040

INTENDED USE

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

STORAGE AND STABILITY

 LACT2
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
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

CALIBRATION

 Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear

CALIBRATION MODE

CALIBRATION FREQUENCY

2‑POINT CALIBRATION

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.2‑15.5 mmol/L (1.8‑140 mg/dL)

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

RESULTS FOR INTERMEDIATE PRECISION WERE OBTAINED ON THE MASTER SYSTEM 501 ANALYZER.

METHOD COMPARISON

Lactate values for human plasma and human CSF 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.