Multi-centric evaluation of Biomeme Franklin Mobile qPCR for rapid detection ofMycobacterium ulceransin clinical specimens

Abstract

The gold standard for Mycobacterium ulcerans detection is PCR due to its high accuracy in confirmation of suspected cases. But the available PCR assays are design for standard size thermocyclers which are immobile and suited for reference laboratories far away from endemic communities. This makes it a challenge to obtain immediate results for patient management. We have validated and evaluated a dried reagent-based PCR assay adapted for a handheld, battery-operated, portable thermocycler with the potential of extending diagnostics to endemic communities with limited infrastructure. The diagnostic accuracy of the assay following a multi-centre evaluation by three Buruli ulcer reference laboratories with over 300 clinical samples showed sensitivity and specificity of 100% - 97% and 100% - 94%. This assay coupled with a field-friendly extraction method fulfill almost all the target product profile of Buruli ulcer for decentralized testing at districts, health centres and community level. A key critical action for achieving the NTD Road Map 2030 target for Buruli ulcer.