biostudies-literatureJouet AEuropean & Developing Countries Clinical Trials Partnership (EDCTP)104649https://www.ebi.ac.uk/biostudies/studies/S-EPMC10279541biostudies-literatureUnknown93<h4>Background</h4>Expansion of antimicrobial resistance monitoring and epidemiological surveillance are key components of the WHO strategy towards zero leprosy. The inability to grow Mycobacterium leprae in vitro precludes routine phenotypic drug susceptibility testing, and only limited molecular tests are available. We evaluated a culture-free targeted deep sequencing assay, for mycobacterial identification, genotyping based on 18 canonical SNPs and 11 core variable-number tandem-repeat (VNTR) markers, and detection of rifampicin, dapsone and fluoroquinolone resistance-associated mutations in rpoB/ctpC/ctpI, folP1, gyrA/gyrB, respectively, and hypermutation-associated mutations in nth.<h4>Methods</h4>The limit of detection (LOD) was determined using DNA of M. leprae reference strains andEBioMedicineHi-plex deep amplicon sequencing for identification, high-resolution genotyping and multidrug resistance prediction of Mycobacterium leprae directly from patient biopsies by using Deeplex Myc-Lep.PMC10279541RIA2017NIM-1847Said ASuffys PNBraet SMAbdou WClement MEpaminondas Nicacio de Oliveira do Livramento RESupply PPrado Palacios YYFerre AMoraes MCambau ELaurent YJouet AGaudin CLenoir EBadalato NHasker ELa KRosa PAttoumani NLucena Nde Jong BCBisch GVasconcellos SGrillone SHFontes ABAssoumani YfalseHi-plex deep amplicon sequencing for identification, high-resolution genotyping and multidrug resistance prediction of Mycobacterium leprae directly from patient biopsies by using Deeplex Myc-Lep.<h4>Background</h4>Expansion of antimicrobial resistance monitoring and epidemiological surveillance are key components of the WHO strategy towards zero leprosy. The inability to grow Mycobacterium leprae in vitro precludes routine phenotypic drug susceptibility testing, and only limited molecular tests are available. We evaluated a culture-free targeted deep sequencing assay, for mycobacterial identification, genotyping based on 18 canonical SNPs and 11 core variable-number tandem-repeat (VNTR) markers, and detection of rifampicin, dapsone and fluoroquinolone resistance-associated mutations in rpoB/ctpC/ctpI, folP1, gyrA/gyrB, respectively, and hypermutation-associated mutations in nth.<h4>Methods</h4>The limit of detection (LOD) was determined using DNA of M. leprae reference strains and2023-01-01T00:00:00Z2023 Jul2026-05-28T20:30:50.626Z2024-11-07T10:02:17.199ZS-EPMC102795413732767510.1016/j.ebiom.2023.104649