Tina-quant Complement C4 ver.2

Catalog Number: 03001962322

SYSTEM INFORMATION

Test C4–2, test ID 0-261.

INTENDED USE

In vitro test for the quantitative immunological determination of human complement C4 in human 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 8 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 8 weeks

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS 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 33/60
Typical prozone effect > 10 g/L (> 1000 mg/dL or > 50.0 µmol/L)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 90 µL
Sample 28 µL 10 µL
SR 17 µL 10 µL
Total volume 155 µL

Diluent (H2O)
R1 90 µL
Sample 28 µL 10 µL
SR 17 µL 10 µL
Total volume 155 µL

COBAS INTEGRA 800 test definition

Calibration

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 > 10 g/L (> 1000 mg/dL or > 50.0 µmol/L)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 90 µL
Sample 28 µL 10 µL
SR 17 µL 10 µL
Total volume 155 µL

Calibration

CALIBRATION

Enter the assigned lot-specific C4 value of the undiluted calibrator, indicated in the package insert of the Calibrator f.a.s. Proteins.

Calibrator Calibrator f.a.s. Proteins
Calibration dilution ratio 1:8, 1:16, 1:32, 1:64, 1:150, and 0 g/L performed automatically by the instrument
Calibration mode Logit/log 5
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures.

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.06‑1.0 g/L (0.3‑5.0 µmol/L or 6.0‑100 mg/dL)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:0.06 g/L (0.3 µmol/L or 6.0 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:

CV INTERMEDIATE PRECISION

METHOD COMPARISON

C4 values for human serum samples obtained on a COBAS INTEGRA 400 analyzer (y) using the COBAS INTEGRA Tina‑quant Complement C4 ver.2 reagent 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 COBAS INTEGRA Complement C4 reagent (x).