ONLINE DAT Specimen Validity Test Specific Gravity

Catalog Number: 07053002190

SYSTEM INFORMATION

For cobas c 501 analyzer:

INTENDED USE

In vitro test for the determination of specific gravity 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

b) Std 1 must be entered as 1.000 to ensure the appropriate calibrator concentration is achieved on the analyzers.

Calibrators S1: SVT Calibrator-Specific Gravity, CAL 1, 1.001b)
S2: SVT Calibrator-Specific Gravity, CAL 2, 1.020c)
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: 1.001-1.035

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.

INTERMEDIATE PRECISION