Intended Use

Detection of Rifampicin resistance in Mycobacterium tuberculosis in Truenat MTB/MTB Plus positive human specimen and aids in the diagnosis of MDR-TB. This test detects the presence of major mutations (SNPs) in the MTB genome that are known to cause resistance to rifampicin

Key Features

- Assay based on Taqman chemistry

- High primer sensitivity and specificity

- Micro chip based real-time PCR assay

- Minimal sample requirement @ 6µL

- Smart chip with lot specific data for quantitation of results

- Chip re-use lock

- Reaction port with contamination/evaporation resistant design

Contents of the Kit

A. Individually sealed pouches, each containing

    1. Truenat MTB-RIF Dx micro PCR chip

    2. Microtube with freeze dried PCR reagents

    3. DNase & RNase free pipette tip

    4. Desiccant pouch

B. Package Insert