Validation of the GenoType^®MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam

• Main Authors: Kremer Kristin, Buu Tran N, Sy Dinh N, Dung Nguyen H, Cobelens Frank GJ, Lan Nguyen TN, Tiemersma Edine W, Huyen Mai NT, Hang Pham T, Caws Maxine, O'Brien Richard, van Soolingen Dick
• Format: Article
• Language: English
• Published: BMC 2010-06-01
• Series: BMC Infectious Diseases
• Online Access: http://www.biomedcentral.com/1471-2334/10/149

<p>Abstract</p> <p>Background</p> <p>To control multidrug resistant tuberculosis (MDR-TB), the drug susceptibility profile is needed to guide therapy. Classical drug susceptibility testing (DST) may take up to 2 to 4 months. The GenoType^®MTBDR<it>plus </it>test is a commercially available line-probe assay that rapidly detects <it>Mycobacterium tuberculosis </it>(MTB) complex, as well as the most common mutations associated with rifampin and isoniazid resistance.</p> <p>We assessed sensitivity and specificity of the assay by using a geographically representative set of MTB isolates from the South of Vietnam.</p> <p>Methods</p> <p>We re-cultured 111 MTB isolates that were MDR, rifampin-resistant or pan-susceptible according to conventional DST and tested these with the GenoType^®MTBDR<it>plus </it>test.</p> <p>Results</p> <p>By conventional DST, 55 strains were classified as MDR-TB, four strains were rifampicin mono-resistant and 52 strains were susceptible to all first-line drugs. The sensitivity of the GenoType^®MTBDR<it>plus </it>was 93.1% for rifampicin, 92.6% for isoniazid and 88.9% for the combination of both; its specificity was 100%. The positive predictive value of the GenoType^®MTBDR<it>plus </it>test for MDR-TB was 100% and the negative predictive value 90.3%.</p> <p>Conclusions</p> <p>We found a high specificity and positive predictive value of the GenoType^®MTBDR<it>plus </it>test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.</p>