GenoType LepraeDR (Line Probe Assay)
DNA strip hybridisation assay identifying M. leprae and detecting rpoB, folP1 and gyrA mutations conferring resistance to rifampicin, dapsone and ofloxacin. It is the only CE-marked molecular product specific to leprosy.
- Technology
- Drug Resistance Testing · Line probe assay
- What it measures
- M. leprae DNA and rpoB, folP1 and gyrA resistance mutations
- Developer
- Hain Lifescience GmbH, a Bruker company (Nehren, Germany)
- Specimen
- Slit-skin smear
- Development status
- Commercial RUO with clinical validation
- Regulatory status
- CE marked
- Intended use
- Species identification with rifampicin, dapsone and ofloxacin resistance genotyping
- Main limitation
- Needs three instruments and bacilli-rich specimens, so it is unsuitable for low-resource settings.
- Availability
- Available from Bruker (Hain Lifescience) as GenoType LepraeDR VER 1.0 (checked 18 September 2026).
- Linked publications
- 5
- Collaborating institutions
- French National Reference Centre for Mycobacteria, AP-HP (Paris, France), Université Paris Diderot and Université Pierre et Marie Curie (Paris, France), Leprosy Research Center, National Institute of Infectious Diseases (Tokyo, Japan), Fondation Raoul Follereau (France)
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