Xpert MTB/RIF Assay, kit/50

General description:
The Xpert MTB/RIF Assay is a qualitative, real-time polymerase chain reaction (PCR) in vitro diagnostic test for detection of Mycobacterium tuberculosis (MTB) complex DNA in sputum performed on the GeneXpert Instrument Systems. The Xpert MTB/RIF Assay can also detect rifampin-resistance associated mutations of the rpoB gene, where MTB complex is detected. The Xpert MTB/RIF Ultra Assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

Materials included in the kit:
50 x Reaction Tubes
50 x Sample Reagent Bottles
60 x Disposable Transfer Pipettes
1 x CD

Materials required but not provided:
GeneXpert Instrument System (catalogue number varies by configuration): 6-color GeneXpert instrument, computer with proprietary GeneXpert Software Version 4.3 or higher, barcode scanner, and operator manual
Printer
Leak-proof, sterile, screw-capped collection containers
Disposable gloves, eye protection, laboratory coats, and labels or permanent marking pen
Timer
Sterile pipettes for sample processing

Product Code:
GXMTB/RIF-50

Shelf life:
17 months

Storage and temperature instructions:
2 - 28°C
Do not open a cartridge lid until you are ready to perform testing.

Material safety data sheet information (MSDS):
Can be found at www.cepheid.com