Multi-Centric Evaluation of Biomeme Franklin Mobile qPCR for Rapid Detection of Mycobacterium Ulcerans in Clinical Specimens
Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
PLOS
Abstract
The gold standard for detection of Mycobacterium ulcerans is PCR due to its high accuracy
in confirmation of suspected cases. But the available PCR assays are designed for standard
size thermocyclers which are immobile and suited for reference laboratories often located
long distances from endemic communities. This makes it a challenge to obtain immediate
results for patient management. We validated and evaluated a dried reagent-based PCR
assay adapted for a handheld, battery-operated, portable thermocycler with the potential to
extend diagnostics to endemic communities with limited infrastructure. The diagnostic accuracy
of the assay following a multi-center evaluation by three Buruli ulcer reference laboratories
with over 300 clinical samples showed sensitivity and specificity of 100–97% and 100–
94%, respectively using centralized IS2404 quantitative PCR platform as a reference standard.
This assay coupled with a field-friendly extraction method fulfill almost all the target
product profiles of Buruli ulcer for decentralized testing at the district, health center and community
levels; a key critical action for achieving the NTD Road Map 2030 target for Buruli
ulcer.
Description
Research Article
Keywords
Multi-centric, Buruli ulcer
Citation
Frimpong M, Frimpong VNB, Numfor H, Donkeng Donfack V, Amedior JS, Deegbe DE, et al. (2023) Multi-centric evaluation of Biomeme Franklin Mobile qPCR for rapid detection of Mycobacterium ulcerans in clinical specimens. PLoS Negl Trop Dis 17(5): e0011373. https://doi. org/10.1371/journal.pntd.0011373