Leprosy Diagnostic Landscape

Real-Time Quantitative PCR (qPCR) for RLEP and Other Targets

Closed-tube real-time amplification and quantification of M. leprae DNA, most often the RLEP element, present in approximately 37 copies per genome. It is the most extensively characterised molecular assay in leprosy and the basis of most contact and transmission studies. Performance values refer to RLEP-based assays.

Technology
Molecular (NAAT) · Real-time 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 and quantification of bacillary load in clinical and contact specimens
Main limitation
Less sensitive in paucibacillary disease and needs a regional laboratory.
Linked publications
83
TPP-1, confirming leprosy
32.0 of 100, low alignment
TPP-2, infection in contacts
28.5 of 100, low alignment
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