Direct Bilirubin

Catalog Number: 04924495190

SYSTEM INFORMATION

INTENDED USE

For the quantitative determination of direct bilirubin in serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

APPLICATION FOR SERUM AND PLASMA

CALIBRATION

Use a K factor. The K factor is 237 if reporting to one decimal place or 2372 if reporting to two decimal places.

CALIBRATION MODE

CALIBRATION FREQUENCY

LIMITS AND RANGES

MEASURING RANGE

0.2-10.0 mg/dL (3.5-171 ┬Ámol/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