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Journal of Clinical Microbiology, January 2005, p. 271-276, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.271-276.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Dry-Reagent-Based PCR as a Novel Tool for Laboratory Confirmation of Clinically Diagnosed Mycobacterium ulcerans-Associated Disease in Areas in the Tropics Where M. ulcerans Is Endemic

V. Siegmund,1* O. Adjei,2 P. Racz,1 C. Berberich,2 E. Klutse,3 F. van Vloten,1 T. Kruppa,2 B. Fleischer,1 and G. Bretzel1

Department of Medical Microbiology and Immunology, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany,1 Kumasi Centre for Collaborative Research in Tropical Medicine, Kwame Nkrumah University of Science and Technology, Kumasi,2 Dunkwa Government Hospital, Dunkwa-on-Offin, Ghana3

Received 22 June 2004/ Returned for modification 20 August 2004/ Accepted 21 September 2004

After tuberculosis and leprosy, Buruli ulcer (BU), caused by Mycobacterium ulcerans, is the third most common mycobacterial disease in immunocompetent humans. The disease occurs in tropical countries, with foci in West Africa, Central Africa, and the western Pacific. BU is defined as an infectious disease involving the skin and the subcutaneous adipose tissue characterized by a painless nodule, papule, plaque, or edema, evolving into a painless ulcer with undermined edges and often leading to invalidating sequelae. Due to the fundamental lack of understanding of modes of transmission, disease control in endemic countries is limited to early case detection through improved active surveillance and surgical treatment. The laboratory confirmation of BU is complicated by the absence of a diagnostic "gold standard." Therefore, misclassification and delayed diagnosis of BU may occur frequently, causing a considerable socioeconomic impact in terms of treatment costs due to prolonged hospitalization. In order to respond to the urgent need to develop reliable tools for early case detection and to overcome technical difficulties accompanying the implementation of diagnostic PCR procedures in tropical countries, a dry-reagent-based PCR formulation for the detection of M. ulcerans in diagnostic specimens has been developed at the Bernhard Nocht Institute for Tropical Medicine. Following technical and clinical validation, the assay has been successfully installed and field tested at the Kumasi Centre for Collaborative Research in Tropical Medicine, Kumasi, Ghana. Preliminary results show an excellent diagnostic sensitivity of >95%.

* Corresponding author. Mailing address: Department of Medical Microbiology and Immunology, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany. Phone: 49 40 42 81 84 67. Fax: 49 40 42 81 84 00. E-mail: siegmund{at}bni-hamburg.de.

Journal of Clinical Microbiology, January 2005, p. 271-276, Vol. 43, No. 1
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.1.271-276.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.





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