Multi-centric evaluation of Biomeme Franklin Mobile qPCR for rapid detection of Mycobacterium ulcerans in clinical specimens
Preprint
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.Keywords
This publication has 15 references indexed in Scilit:
- Elimination within reach: A cross-sectional study highlighting the factors that contribute to persistent lymphatic filariasis in eight communities in rural GhanaPLOS Neglected Tropical Diseases, 2019
- Rapid Detection and Monitoring of Flavobacterium psychrophilum in Water by Using a Handheld, Field-Portable Quantitative PCR SystemJournal of Aquatic Animal Health, 2018
- PCR detection ofMycobacterium ulcerans—significance for clinical practice and epidemiologyExpert Review of Molecular Diagnostics, 2018
- Clinical and Laboratory Diagnosis of Buruli Ulcer Disease: A Systematic ReviewCanadian Journal of Infectious Diseases and Medical Microbiology, 2016
- Implementation of a National Reference Laboratory for Buruli Ulcer Disease in TogoPLOS Neglected Tropical Diseases, 2013
- Reciprocal Tripartite Interactions between the Aedes aegypti Midgut Microbiota, Innate Immune System and Dengue Virus Influences Vector CompetencePLOS Neglected Tropical Diseases, 2012
- Combining PCR with Microscopy to Reduce Costs of Laboratory Diagnosis of Buruli UlcerThe American Journal of Tropical Medicine and Hygiene, 2011
- Laboratory Diagnosis of Buruli Ulcer DiseaseFuture Microbiology, 2010
- Sensitivity of PCR Targeting Mycobacterium ulcerans by Use of Fine-Needle Aspirates for Diagnosis of Buruli UlcerJournal of Clinical Microbiology, 2009
- Dry Reagent-Based Polymerase Chain Reaction Compared with Other Laboratory Methods Available for the Diagnosis of Buruli Ulcer DiseaseClinical Infectious Diseases, 2007