Leprosy Diagnostic Landscape

IBMP Kit Biomol Hanseníase (qPCR)

A registered real-time PCR kit detecting the M. leprae 16S rRNA and RLEP targets, with a human 18S rRNA internal control, in DNA from skin or nerve biopsies. It is used in the Brazilian public health system to investigate contacts of leprosy cases and, since July 2026, to aid the diagnosis of suspected cases.

Technology
Molecular (NAAT) · Real-time PCR kit
What it measures
M. leprae DNA (16S rRNA and RLEP)
Developer
Instituto de Biologia Molecular do Paraná (IBMP) with Fiocruz (Instituto Oswaldo Cruz and Instituto Carlos Chagas), Brazil
Specimen
Skin biopsy
Development status
Nationally registered with clinical validation
Regulatory status
National approval
Intended use
Aid to the diagnosis of leprosy on skin or nerve biopsy DNA, including investigation of contacts
Main limitation
Needs a biopsy and a real-time PCR laboratory, and its clinical data come from its developers.
Availability
Available from IBMP, which lists the kit among its products (checked 18 September 2026), and bought by the Brazilian Ministry of Health.
Linked publications
1
Collaborating institutions
École Polytechnique Fédérale de Lausanne (Switzerland), Colorado State University (Fort Collins, CO, USA), Instituto Nacional de Infectologia Evandro Chagas (Rio de Janeiro, Brazil)
TPP-1, confirming leprosy
27.0 of 100, low alignment
TPP-2, infection in contacts
23.5 of 100, low alignment
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