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 FindingsThe 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/SignificanceOngoing 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.
Highlights
The implementation of PCR-based methods for the detection of Mycobacterium ulcerans, the causative organism of Buruli ulcer (BU), in clinical and environmental samples 15 years ago [1,2,3] has drastically improved our knowledge of BU
A total of 11 laboratories from 11 countries participated in the first round of the clinical external quality assessment program (EQAP) while 18 laboratories from 15 countries took part in the second round (Table 1)
The results of the two rounds of clinical and environmental EQAP indicated that there is a great variation between laboratories in the quality of molecular detection of M. ulcerans from clinical and environmental samples
Summary
The implementation of PCR-based methods for the detection of Mycobacterium ulcerans, the causative organism of Buruli ulcer (BU), in clinical and environmental samples 15 years ago [1,2,3] has drastically improved our knowledge of BU. Among the available laboratory tests (direct smear examination for acid fast bacilli, culture, PCR and histopathology), PCR targeting the insertion element IS2404 (present in over 200 copies in the M. ulcerans genome) is by far the most sensitive and specific, and much faster than culture, which takes an average of 10 weeks and only has 45% sensitivity despite many efforts to improve decontamination methods, culture media and incubation conditions [6,7,8,9,10]. 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
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