Benzodiazepines Plus

Catalog Number: 04490789190

SYSTEM INFORMATION

INTENDED USE

Benzodiazepines Plus (BENZ) is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on Roche/Hitachi cobas c systems at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).

STORAGE AND STABILITY

COBAS C TEST DEFINITION - 100 NG/ML CUTOFF ASSAY

CALIBRATION

CALIBRATION K FACTOR

FOR THE QUALITATIVE APPLICATIONS, ENTER THE K FACTOR AS -1000 INTO THE CALIBRATION MENU, STATUS SCREEN, CALIBRATION RESULT WINDOW.

CALIBRATION MODE

CALIBRATION FREQUENCY

FULL (SEMIQUANTITATIVE) OR BLANK (QUALITATIVE) CALIBRATIONā€¢ AFTER REAGENT LOT CHANGEā€¢ AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

SEE THE "SPECIFIC PERFORMANCE DATA" SECTION OF THIS DOCUMENT FOR INFORMATION ON SUBSTANCES TESTED WITH THIS ASSAY. THERE IS THE POSSIBILITY THAT OTHER SUBSTANCES AND/OR FACTORS MAY INTERFERE WITH THE TEST AND CAUSE ERRONEOUS RESULTS (E.G., TECHNICAL OR PROCEDURAL ERRORS).

SPECIFIC PERFORMANCE DATA

PRECISION

SEMIQUANTITATIVE PRECISION - 100 NG/ML

QUALITATIVE PRECISION - 100 NG/ML

SEMIQUANTITATIVE PRECISION - 200 NG/ML

QUALITATIVE PRECISION - 200 NG/ML

SEMIQUANTITATIVE PRECISION - 300 NG/ML

QUALITATIVE PRECISION - 300 NG/ML

ANALYTICAL SPECIFICITY

ARMBRUSTER DA, SCHWARZHOFF RH, PIERCE BL, ET AL. METHOD COMPARISON OF EMIT II AND ONLINE WITH RIA FOR DRUG SCREENING. J FORENSIC SCI 1993;38:1326-1341.