Total Protein Urine/CSF Gen.3

Catalog Number: 03333825190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of protein in human urine and cerebrospinal fluid on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

TPUC3
Shelf life at 15-25 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 6 weeks
NaCl Diluent 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

Calibrators S1: H2O
S2-S6: C.f.a.s. PUC
Multiply the lot-specific C.f.a.s. PUC calibrator values by the factors given below to determine the standard concentrations for the 6-point calibration curve.

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

IF RUNNING SEQUENTIAL CALIBRATIONS, PERFORM A SAMPLE PROBE WASH BETWEEN THE CALIBRATIONS. EXECUTE A SAMPLE PROBE WASH FROM THE UTILITY MENU, MAINTENANCE TAB, MAINTENANCE SCREEN. CHOOSE (12) SAMPLE PROBE WASH > SELECT > EXECUTE 1 CYCLE.

HIGH DOSE HOOK-EFFECT: SAMPLE RESULTS WITH HIGH TOTAL PROTEIN CONCENTRATIONS ABOVE THE MEASURING RANGE UP TO 100000 MG/L WILL BE FLAGGED BY THE INSTRUMENT WITH > TEST OR > ABS.

40-2000 mg/L (4-200 mg/dL)

LIMITS AND RANGES

Measuring range

MEASURING RANGE

40-2000 mg/L (4-200 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, 10 days).

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, 10 DAYS).

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

Total protein values for human urine and CSF samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) using C.f.a.s. PUC calibrator were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x) using TPUC 200 calibrator.

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.