Xpert MTB/RIF Ultra Assay, kit/50

General description:
The Xpert MTB/RIF Ultra Assay is a semi-qualitative, in vitro diagnostic test for detection of Mycobacterium tuberculosis (MTB), performed on the GeneXpert Instrument Systems. The Xpert MTB/RIF Ultra 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 in the last 6 months. 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:
Xpert MTB/RIF Ultra Assay-50 Kit includes:
50 x Reaction Tubes
50 x Sample Reagent Bottles
60 x Disposable Transfer Pipettes
1 x CD

Materials required but not provided:
GeneXpert Dx System or GeneXpert Infinity Systems: GeneXpert Instrument, computer, barcode scanner, and operator manual
Printer
Leak-proof, sterile screw-capped collection containers
Disposable gloves
Labels and/or indelible labeling marker
Sterile pipettes for sample processing

Product Code:
GXMTB/RIF-ULTRA-50

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):
MSDS is available on www.cepheid.com