Tina-quant Transferrin ver.2

Catalog Number: 03015050122

SYSTEM INFORMATION

Test TRSF2, test ID 0-567

INTENDED USE

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

Specimen collection and preparation

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 340 nm
Calc. first/last 33/50
Typical prozone effect > 17 g/L (> 214 μmol/L or > 1700 mg/dL)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 140 µL
Sample 12.5 µL 5 µL
SR 30 µL 5 µL
Total volume 192.5 µL

Diluent (H2O)
R1 140 µL
Sample 12.5 µL 5 µL
SR 30 µL 5 µL
Total volume 192.5 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 340 nm
Calc. first/last 44/82
Typical prozone effect > 17 g/L (> 214 μmol/L or > 1700 mg/dL)
Antigen excess check No
Predilution factor 21
Unit g/L

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 140 µL
Sample 12.5 µL 5 µL
SR 30 µL 5 µL
Total volume 192.5 µL

Calibration

CALIBRATION

Enter the assigned lot-specific transferrin value of the undiluted calibrator, indicated in the method sheet of the Calibrator f.a.s. Proteins.

Calibrator Calibrator f.a.s. Proteins
Calibration dilution ratio 1:10.5, 1:21, 1:42, 1:83, 1:170, 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

0.1-5.2 g/L (1.26-65.5 μmol/L or 10-520 mg/dL) (typical measuring range)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:

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 (3 aliquots per run, 1 run per day, 10 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, 10 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Transferrin values for human serum samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Tina-quant Transferrin ver.2 reagent (y) were compared to the same reagent on a COBAS INTEGRA 400 analyzer (x) and to those of an alternative manufacturer’s automated system (nephelometric determination) (x).