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Journal of Clinical Microbiology, December 2008, p. 4023-4028, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01101-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Development and Evaluation of a Molecular Assay for Detection of Nontuberculous Mycobacteria by Use of the Cobas Amplicor Platform{triangledown}

S. Peter-Getzlaff,* J. Lüthy, B. Böddinghaus,{dagger} E. C. Böttger, and B. Springer{ddagger}

Institut für Medizinische Mikrobiologie, Universität Zürich, Zürich, Switzerland, and Nationales Zentrum für Mykobakterien, Gloriastr. 30, CH-8006 Zürich, Switzerland

Received 10 June 2008/ Returned for modification 19 August 2008/ Accepted 12 October 2008

We have developed and evaluated a semiautomated assay for detection of nontuberculous mycobacteria (NTM) from clinical samples based on the Cobas Amplicor Mycobacterium tuberculosis test (Roche Diagnostics, Switzerland). A capture probe, specific for mycobacteria at the genus level, was linked to magnetic beads and used for the detection of amplification products obtained by the Cobas Amplicor M. tuberculosis assay. We demonstrate that the analytical sensitivity of the genus assay is similar to that of Cobas Amplicor M. tuberculosis detection. Four hundred sixteen clinical specimens were evaluated for the presence of NTM DNA. Sensitivities for smear-positive and smear-negative specimens were found to be 100% and 47.9%, respectively. Specificity was 97.7%, the positive predictive value 84.6%, and the negative predictive value 93.1%. The genus assay is easy to perform, produces reliable results, and was found to be a valuable diagnostic tool for rapid diagnosis of infections with NTM. The genus assay has the potential to detect NTM not routinely recovered by culture and to discover new mycobacterial species.

* Corresponding author. Mailing address: Institut für Medizinische Mikrobiologie, Gloriastrasse 30/32, 8006 Zürich, Switzerland. Phone: 41 44 634-0520. Fax: 41 44 634-4906. E-mail: silke.peter{at}immv.uzh.ch

{triangledown} Published ahead of print on 22 October 2008.

{dagger} Present address: Gesundheitsamt der Stadt Frankfurt am Main, Braubachstraße 18-22, D-60311 Frankfurt am Main, Germany.

{ddagger} Present address: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für Medizinische Mikrobiologie und Hygiene, Beethovenstrasse 6, A-8010 Graz, Austria.

Journal of Clinical Microbiology, December 2008, p. 4023-4028, Vol. 46, No. 12
0095-1137/08/$08.00+0     doi:10.1128/JCM.01101-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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