Tina-quant Complement C3c ver.2

Catalog Number: 03001938322

SYSTEM INFORMATION

Test C3C-2, test ID 0-260

INTENDED USE

In vitro test for the quantitative immunological determination of human complement C3c in serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

 Shelf life at 2‑8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10‑15 °C 6 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 6 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition 

PIPETTING PARAMETERS

  Diluent (H2O)
R1 90 µL
Sample 10 µL 10 µL
SR 17 µL 10 µL
Total volume 137 µL

COBAS INTEGRA 800 test definition

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode D-R1-S-SR
Reaction direction Increase
Wavelength A/B 340/659 nm
Calc. first/last 44/90
Typical prozone effect > 13.6 g/L (> 1360 mg/dL)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters 

CALIBRATION

Calibrator Calibrator f.a.s. Proteins

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.3‑5.0 g/L (30‑500 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test: 0.3 g/L (30 mg/dL)

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA 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 (1 aliquot 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 (1 ALIQUOT PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

C3c values for human serum samples obtained on a COBAS INTEGRA 400 analyzer using the COBAS INTEGRA Tina‑quant Complement C3c ver.2 reagent (C3C‑2) (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x) and with those determined on a COBAS INTEGRA 400 analyzer using the previous reagent COBAS INTEGRA Complement C3c (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.