Tina-quant Complement C3c ver.2

Catalog Number: 05991986190

SYSTEM INFORMATION

C3C‑2: ACN 8036

INTENDED USE

In vitro test for the quantitative determination of Complement C3c in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

C3C‑2

APPLICATION FOR SERUM AND PLASMA

cobas c 701/702 test definition

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrators S1: H2O S2‑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 six‑point calibration curve:
S2: 0.105S3: 0.210S4: 0.420 S5: 1.05S6: 2.10
Calibration mode RCM2
Calibration frequency Full calibration- after reagent lot change- 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 SIX‑POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

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

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.04‑5.0 g/L (4‑500 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:

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

METHOD COMPARISON

C3c values for human serum and plasma 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.