Conventional PCR (RLEP and Other Targets)
End-point amplification of M. leprae DNA, most often the multicopy RLEP repetitive element, with agarose gel or nested detection. It is widely reported and has low reagent costs, but is performed in an open-tube format with a risk of amplicon carry-over and gives no quantitative output. Performance values refer to RLEP-based assays.
- Technology
- Molecular (NAAT) · End-point PCR
- What it measures
- M. leprae DNA (RLEP and other targets)
- Developer
- Multiple laboratories
- Specimen
- Slit-skin smear
- Development status
- LDT with clinical validation
- Regulatory status
- None / RUO
- Intended use
- Confirmation of infection in bacilli-rich specimens
- Main limitation
- Open-tube format with a risk of amplicon carry-over, and no quantitative result.
- Linked publications
- 312
- TPP-1, confirming leprosy
- 22.0 of 100, low alignment
- TPP-2, infection in contacts
- 14.5 of 100, low alignment
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