Total Protein Gen. 2

Catalog Number: 03183734190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

 TP2
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
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

APPLICATION FOR SERUM AND PLASMA

 cobas c 311 test definition
Assay type 2‑Point End
Reaction time / Assay points 10 / 6‑23(STAT 5 / 6‑23)
Wavelength (sub/main) 700 / 546 nm
Reaction direction Increase
Units g/L (g/dL)
Reagent pipetting Diluent (H2O)
R1 90 µL 28 µL
R2 32 µL

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

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

2.0‑120 g/L (0.2‑12 g/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:

METHOD COMPARISON

Total protein values for human serum samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 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.