Tina-quant β2-Microglobulin

Catalog Number: 05950783190

SYSTEM INFORMATION

INTENDED USE

Immunoturbidimetric assay for the quantitative in vitro determination of β2-microglobulin in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

APPLICATION FOR SERUM AND PLASMA

CALIBRATION

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

MEASURING RANGE

0.1-8.0 mg/L (8.5-678 nmol/L)

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 (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 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.