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Journal of Clinical Microbiology, July 2006, p. 2485-2491, Vol. 44, No. 7
0095-1137/06/$08.00+0     doi:10.1128/JCM.00083-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Use of Genotype MTBDR Assay for Molecular Detection of Rifampin and Isoniazid Resistance in Mycobacterium tuberculosis Clinical Strains Isolated in Italy

Paolo Miotto,1 Federica Piana,1 Valeria Penati,2 Filippo Canducci,3 Giovanni Battista Migliori,4 and Daniela Maria Cirillo1*

Emerging Bacterial Pathogens, San Raffaele Scientific Institute, Milan, Italy,1 Istituto Villa Marelli, Milan, Italy,2 Vita-Salute San Raffaele University and Microbiology and Virology Laboratory, Milan, Italy,3 WHO Collaborating Centre for Tuberculosis and Lung Disease, S. Maugeri Foundation, IRCCS, Tradate, Italy4

Received 13 January 2006/ Returned for modification 27 March 2006/ Accepted 1 May 2006

Mycobacterium tuberculosis is one of the leading causes of death worldwide, and multidrug-resistant tuberculosis (MDR-TB) is associated with a high case fatality rate. Rapid identification of resistant strains is crucial for the early administration of appropriate therapy, for prevention of development of further resistance, and to curtail the spread of MDR strains. The Genotype MTBDR (Hain Lifescience, Nehren, Germany) is a reverse hybridization line probe assay designed for the rapid detection of rpoB and katG gene mutations in clinical isolates. The ability of this technique to correctly identify resistant and MDR-TB strains was tested on 206 isolates from the Italian drug resistance surveillance system. This panel included the majority of MDR strains isolated in Italy in the past 3 years. The results of the test were compared to conventional drug susceptibility test performed on isolated strains and verified by sequencing the regions of interest of the bacterial genome. The rate of concordance between the results of the MTBDR and those obtained with "in vitro" sensitivity was 91.5% (130 of 142) for rifampin and 67.1% (116 of 173) for isoniazid. We also applied this test directly to a panel of 36 clinical specimens collected from patients with active TB. The MTBDR correctly identified the two cases of MDR-TB included in the panel. These results show that the MTBDR test is useful in the detection and management of tuberculosis when MDR disease is suspected.

* Corresponding author. Mailing address: Emerging Bacterial Pathogens, San Raffaele-Turro, via Stamira d'Ancona 20, 20127 Milan, Italy. Phone: 39 02 26437947. Fax: 39 02 26437989. E-mail: cirillo.daniela{at}hsr.it.

Journal of Clinical Microbiology, July 2006, p. 2485-2491, Vol. 44, No. 7
0095-1137/06/$08.00+0     doi:10.1128/JCM.00083-06
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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