Multicenter external quality assessment program for PCR detection of Mycobacterium ulcerans in clinical and environmental specimens

PLoS One. 2014 Feb 21;9(2):e89407. doi: 10.1371/journal.pone.0089407. eCollection 2014.

Abstract

Background: Mycobacterium ulcerans is the causative agent of Buruli ulcer (BU), a necrotizing disease of the skin, soft tissue and bone. PCR is increasingly used in the diagnosis of BU and in research on the mode of transmission and environmental reservoir of M. ulcerans.

Methodology/principal findings: The aim of this study was to evaluate the performance of laboratories in detecting M. ulcerans using molecular tests in clinical and environmental samples by implementing sequential multicenter external quality assessment (EQA) programs. The second round of the clinical EQA program revealed somewhat improved performance.

Conclusions/significance: Ongoing EQA programs remain essential and continued participation in future EQA programs by laboratories involved in the molecular testing of clinical and environmental samples for M. ulcerans for diagnostic and research purposes is strongly encouraged. Broad participation in such EQA programs also benefits the harmonization of quality in the BU research community and enhances the credibility of advances made in solving the transmission enigma of M. ulcerans.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Buruli Ulcer / diagnosis*
  • Environment
  • Humans
  • Molecular Diagnostic Techniques / standards*
  • Mycobacterium ulcerans / isolation & purification*
  • Polymerase Chain Reaction / standards*
  • Quality Assurance, Health Care*

Grants and funding

This work was supported by the Global Buruli Ulcer Initiative of the World Health Organization, the Stop Buruli Initiative funded by the UBS Optimus Foundation (Zurich, Switzerland) and by the European Commission (project HEALTH-F3-2010-241500-BuruliVac). C.L. was supported by a Victorian Government Department of Public Health Grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.