ONLINE DAT Specimen Validity Test Creatinine

Catalog Number: 07055676190

SYSTEM INFORMATION

For cobas c 501 analyzer:

INTENDED USE

In vitro test for the determination of creatinine in urine specimens as a means to detect sample adulteration for Drugs of Abuse Testing on Roche/Hitachi cobas c clinical chemistry analyzers.

STORAGE AND STABILITY

CALIBRATION

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Urine: 1.0-25.0 mg/dL

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Repeatability was determined using a series of controls in an internal protocol (n = 21, 1 run). Intermediate precision was determined using a series of controls in replicates of 20 for 5 days. The following results were obtained:

REPEATABILITY WAS DETERMINED USING A SERIES OF CONTROLS IN AN INTERNAL PROTOCOL (N = 21, 1 RUN). INTERMEDIATE PRECISION WAS DETERMINED USING A SERIES OF CONTROLS IN REPLICATES OF 20 FOR 5 DAYS. THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the creatinine determination using Roche ONLINE DAT Specimen Validity Test Creatinine on the Roche/Hitachi cobas c 501 analyzer vs. Roche ONLINE DAT Specimen Validity Test Creatinine on the Roche/Hitachi MODULAR P analyzer gave the following correlation (mg/dL):