Cartridge-Based Automated NAAT (GeneXpert and Truenat Class)

Sample-to-answer real-time PCR on instruments already installed at district level for tuberculosis testing. Molbio lists Truenat M. leprae, a chip for semi-quantitative detection of M. leprae in slit-skin smears. No GeneXpert leprosy cartridge is on the market, and no independent clinical evaluation of the chip has been published.

Technology

Molecular (NAAT) · Integrated cartridge PCR

What it measures

M. leprae DNA (16S rRNA gene, sodA and RLEP on Truenat M. leprae)

Developer

Molbio Diagnostics (Goa, India), for Truenat M. leprae

Specimen

Slit-skin smear

Development status

Commercial RUO with analytical validation

Regulatory status

None / RUO

Intended use

District-level confirmation on instrumentation already deployed for tuberculosis

Main limitation

The leprosy chip is listed by its manufacturer, but no independent clinical evaluation has been published.

Availability

Truenat M. leprae is listed by Molbio Diagnostics with ordering codes (checked 18 September 2026). No GeneXpert cartridge for leprosy is available.

Linked publications

TPP-1, confirming leprosy

39.0 of 100, partial alignment

TPP-2, infection in contacts

37.5 of 100, partial alignment

All 37 tests · Home