Tina-quant Complement C4 ver.2

Catalog Number: 05991994190

SYSTEM INFORMATION

C4‑2: ACN 8032

INTENDED USE

Immunoturbidimetric assay for the in vitro quantitative determination of human C4 in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 C4‑2
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

APPLICATION FOR SERUM AND PLASMA

 cobas c 701/702 test definition
Assay type 2‑Point End
Reaction time / Assay points 10 / 18‑38
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 90 µL
R3 17 µL 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 15 µL 15 µL 150 µL
Decreased 15 µL 8 µL 168 µL
Increased 15 µL 20 µL 90 µL

CALIBRATION

Traceability: This method has been standardized against the reference preparation of the IRMM (Institute for Reference Materials and Measurements) BCR470/CRM470 (RPPHS - Reference Preparation for Proteins in Human Serum).6

 Calibrators S1: H2OS2‑S6: C.f.a.s. Proteins
Multiply the lot‑specific C.f.a.s. Proteins calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.140 S5: 1.31
S3: 0.328 S6: 2.64
S4: 0.655
Calibration mode RCM2
Calibration frequency Full calibration- after reagent lot change - and as required following quality control procedures

MULTIPLY THE LOT‑SPECIFIC C.F.A.S. PROTEINS CALIBRATOR VALUE BY THE FACTORS BELOW TO DETERMINE THE STANDARD CONCENTRATIONS FOR THE 6‑POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION- AFTER REAGENT LOT CHANGE- AND AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.02‑1.0 g/L (0.1‑5 µmol/L, 2.0‑100 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

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

METHOD COMPARISON

C4 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the same 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.