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Multi-centric evaluation of Biomeme Franklin Mobile qPCR for rapid detection of Mycobacterium ulcerans in clinical specimens.

Published version
Peer-reviewed

Repository DOI


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Authors

Frimpong, Venus Nana Boakyewaa 
Numfor, Hycenth 
Donkeng Donfack, Valerie 
Amedior, Jennifer Seyram 

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

Keywords

Humans, Mycobacterium ulcerans, Buruli Ulcer, Polymerase Chain Reaction, Nucleic Acid Amplification Techniques, Sensitivity and Specificity

Journal Title

PLoS Negl Trop Dis

Conference Name

Journal ISSN

1935-2727
1935-2735

Volume Title

Publisher

Public Library of Science (PLoS)
Sponsorship
American Leprosy Missions (USA/380)
American Leprosy Missions (RCAM/232)