ONLINE DAT Specimen Validity Test pH

Catalog Number: 07052995190

SYSTEM INFORMATION

For cobas c 501 analyzer:

INTENDED USE

In vitro test for the determination of pH 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

Shelf life at 2-8 °C: See expiration date on cobas c pack label
On-board in use and refrigerated on the analyzer: 8 weeks

Specimen collection and preparation

CALIBRATION

Quality control

Calibrators S1: SVT Calibrator-pH, CAL 1, pH 3.0
S2: SVT Calibrator-pH, CAL 2, pH 11.0
Calibration mode Linear
Calibration frequency 2-point calibration- after cobas c pack change- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2-POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

Urine: 2.5-12

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.

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.

INTERMEDIATE PRECISION