Tina-quant IgG Gen.2

Catalog Number: 03507432190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

: ACN 674 (STANDARD APPLICATION FOR SERUM AND PLASMA)

: ACN 8674 (STANDARD APPLICATION FOR SERUM AND PLASMA)

INTENDED USE

In vitro test for the quantitative determination of IgG in human serum, plasma and cerebrospinal fluid on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 IGG-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
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

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA (IGG-2)

 cobas c 311 test definition
Assay type 2-Point End
Reaction time / Assay points 10 / 6-16
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units g/L (µmol/L, mg/dL)
Reagent pipetting Diluent (H2O)
R1 120 µL
R2 38 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 5 µL 9 µL 180 µL
Decreased 3.9 µL 2 µL 180 µL
Increased 9.4 µL 20 µL 85 µL

CALIBRATION

 

 Serum/plasma application (IGG-2)
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: 0.100 S5: 1.00
S3: 0.250 S6: 3.14
S4: 0.501
Calibration mode cobas c 311 analyzer: Splinecobas c 501/502 analyzers: RCM
Calibration frequency Full calibration▪after reagent lot change▪as required following quality control procedures
 CSF application (IGGC2)
Calibrators S1: H2OS2-S6: C.f.a.s. PUC
Multiply the lot-specific C.f.a.s. PUC calibrator value by the factors below to determine the standard concentrations for the 6‑point calibration curve:
S2: 0.0431 S5: 0.331
S3: 0.0862 S6: 1.00
S4: 0.166
Calibration mode RCM
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 6‑POINT CALIBRATION CURVE:

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

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

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Serum/plasma application (IGG-2):

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

Serum/plasma and CSF:

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

INTERMEDIATE PRECISION

METHOD COMPARISON

Serum/plasma application (IGG-2):

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.