Intended Use of TrueNAT MTB and TrueNAT MTB Rif Dx Assay

TrueNAT MTB and TrueNAT MTB Rif Dx Assay are intended to be used for detection of Mycobacterium tuberculosis bacteria (for TB diagnosis) and to detect resistance to rifampicin (Rif), respectively.

Positioning of TrueNAT MTB and TrueNAT MTB Rif Dx Assay

TrueNAT MTB and TrueNAT MTB Rif Dx Assay are suitable as point-of-care tests for use in peripheral laboratories and microscopy centres due to the following operational features:

• Biosafety requirements similar to smear microscopy
• Sample pre-treatment and preparation kits stable at 2-40°C, while TrueNAT chips stable between 2-30°C
• Test reagents with shelf life of 2 years
• Operates up to 8 hours on fully-charged batteries
• Temperature controlled operation, like air-conditioning, not required (operates up to ≤ 40°C)
• Operates under a wide relative humidity range (10-80%) & dusty conditions
• Portable and comes with a carrying case.

Target population

National TB Elimination Programme (NTEP) has defined the use of Nucleic Acid Amplification Test (NAAT) like Cartridge Based Nucleic Acid Amplification Test (CBNAAT) and TrueNAT as upfront tests for diagnosis of TB in presumptive paediatric TB, presumptive extra-pulmonary cases, People Living with HIV (PLHIV), smear negative X-ray suggestive of TB, contacts of Drug Resistant TB (DR-TB), treatment non-responders, TB affected patients retrieved after loss to follow-up and other vulnerable groups.

Resources

• Guidelines for Programmatic Management of Drug resistant Tuberculosis (PMDT) in India, 2021.
• Practical Guide to Implementation of TrueNAT Tests for the Detection of TB and Rifampicin Resistance.

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