Leprosy Diagnostic Landscape

Multi-Target Multiplex qPCR (RLEP, 16S rRNA, sodA and hsp18)

Simultaneous amplification of RLEP with 16S ribosomal RNA, sodA or hsp18 targets. Multiple targets recover part of the sensitivity deficit in paucibacillary specimens, and RNA targets permit inference of bacillary viability.

Technology
Molecular (NAAT) · Real-time PCR
What it measures
Multiple M. leprae genomic and transcriptomic targets
Developer
Multiple laboratories
Specimen
Slit-skin smear
Development status
LDT with clinical validation
Regulatory status
None / RUO
Intended use
Confirmation with improved paucibacillary yield and inference of bacillary viability
Main limitation
A more complex workflow, validated mostly at single sites.
Linked publications
7
Collaborating institutions
Fiocruz and the Instituto de Biologia Molecular do Paraná (Brazil), Stanley Browne Laboratory, The Leprosy Mission Community Hospital (Delhi, India), Schieffelin Institute of Health Research and Leprosy Centre (Karigiri, India), Postgraduate Institute of Medical Education and Research (Chandigarh, India), ICMR-National JALMA Institute (Agra, India), Institute of Dermatology, Chinese Academy of Medical Sciences (Nanjing, China), Royal Tropical Institute, KIT (Amsterdam, the Netherlands)
TPP-1, confirming leprosy
33.0 of 100, low alignment
TPP-2, infection in contacts
27.5 of 100, low alignment
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