Sanger Sequencing of Drug Resistance-Determining Regions

Amplification and bidirectional dideoxy sequencing of the drug resistance-determining regions of rpoB, folP1 and gyrA. It is the method specified for WHO sentinel surveillance of antimicrobial resistance in leprosy.

Technology

Drug Resistance Testing · Genotypic resistance testing

What it measures

Mutations in the drug resistance-determining regions of rpoB, folP1 and gyrA

Developer

Reference laboratories in the WHO sentinel surveillance network for antimicrobial resistance

Specimen

Slit-skin smear

Development status

LDT with clinical validation

Regulatory status

None / RUO

Intended use

Sentinel surveillance of antimicrobial resistance in relapse and new cases

Main limitation

Amplification fails when few bacilli are present, and it is done only in reference laboratories.

Linked publications

37

Collaborating institutions

National Hansen's Disease Program (Baton Rouge, LA, USA), Leprosy Research Center, National Institute of Infectious Diseases (Tokyo, Japan), Stanley Browne Laboratory, The Leprosy Mission Community Hospital (Delhi, India), Colorado State University (Fort Collins, CO, USA)

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