Total Protein Urine/CSF Gen.3

Catalog Number: 05171954190

SYSTEM INFORMATION

TPUCX: ACN 8471

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: 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

CALIBRATION

Note

 Calibrators S1: H2OS2‑S6: C.f.a.s. PUCMultiply 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.S2: 0.025S3: 0.050S4: 0.125S5: 0.250S6: 1.0
Calibration mode RCM
Calibration frequency Full calibration• after reagent lot change• as required following quality control procedures

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.

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

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). 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, 10 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

Total protein values for human urine and 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.