Tina-quant β2-Microglobulin

Catalog Number: 11660551216

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of β2-microglobulin in human serum and plasma on Roche automated clinical chemistry analyzers. To be used as an aid in the diagnosis of active rheumatoid factor arthritis and kidney disease.

STORAGE AND STABILITY

CALIBRATION

CALIBRATION FREQUENCY

2-POINT CALIBRATION IS RECOMMENDED

LIMITS AND RANGES

MEASURING RANGE

Measuring range: 16.9-678 nmol/L (0.20-8.00 mg/L or µg/mL) 

MEASURING RANGE: 16.9-678 NMOL/L (0.20-8.00 MG/L OR ΜG/ML) 

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

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, 10 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

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.