Specifications The required goods to be provided are: Test kits equivalent to Cepheid MTB/RIF assay (GXMTB/RIF-US-10, MTB, IVD, US, 10 tests/kit) that provide: Sample reagent for the chemical processing of a human clinical specimen such as sputum Cartridges that are injected with the processed human clinical specimen and can be loaded into the GeneXpert for DNA amplification. Disposable transfer pipettes Control kits equivalent to Cepheid MTB/RIF-BU1, Control Bundle, that are used to ensure that each module of the Cepheid GeneXpert instrument is functioning correctly. Requirements 1. Must be compatible with the Cepheid GeneXpert instrument. 2. Test kit cartridges must be able to amplify the Mycobacterium tuberculosis complex DNA in a human clinical specimen so that the Mycobacterium tuberculosis complex present in the specimen is detected. 3. Test kit cartridges must be able to detect mutations in Mycobacterium tuberculosis complex DNA hat cause resistance to the antibiotic rifampin. 4. Test kit cartridges must be compatible with the software that operates the Cepheid GeneXpert instrument and that analyzes the output from each cartridge tested so that the analysis results in a positive (DNA Detected) or a negative (DNA Not Detected) report. 5. Each test cartridge must have built in controls to ensure the amplification and detection are working at acceptable performance levels a. Specificity must be at least 97.8% - 99.7% b. Sensitivity for “AFB Smear Positive specimens must be 94.4% - 100% c. Sensitivity for “AFB Smear Negative” specimens must be 70.3% - 86.2% 6. Control kits must provide a positive control for detecting Mycobacterium tuberculosis complex DNA when present, a negative control for not detecting Mycobacterium tuberculosis complex DNA when it is not present, and a positive control for detecting rifampin resistance when present in the Mycobacterium tuberculosis complex DNA
