Rapid molecular testing for multi-resistant tuberculosis in Mongolia: A diagnostic accuracy study

Objective: The aim of this study was to assess the performance of a molecular line probe assay, GenoType (R) MTBDRplus, for rapid detection of rifampicin and isoniazid resistance in the Mongolian situation. The sensitivity and specificity of GenoType (R) MTBDRplus to detect rifampicin and isoniazid resistance-associated mutations in culture specimens and directly in smear-positive clinical specimens was examined. Method: 218 MDR-TB subjects aged between 14 and 75 years old from eight districts in Ulaanbaatar city (between July 2009 and May 2010) were included in this study. The GenoType Mycobacterium tuberculosis drug resistance first line (MTBDR plus) assay (Hain Life-science, Nehren, Germany) was tested on 109 clinical isolates and directly on 41 sputum specimens for the ability to detect the resistances. Results were compared with conventional culture and drug susceptibility testing on solid medium. Results: The high correlation of the results from GenoType (R) MTBDRplus and conventional drug susceptibility testing was obtained from this study. The results clearly showed a high performance of GenoType (R) MTBDRplus with almost 100% accuracy for all the important indicators, such as sensitivity, specificity, positive and negative predictive values and detection of rifampicin resistance. Discrepancies were obtained in comparison with DNA sequencing results. Conclusions: The Genotype (R) MTBDRplus assay was demonstrated as a rapid, reliable and highly accurate tool for early detection of MDR-TB through examining smear positive cases. (C) 2012 Asian-African Society for Mycobacteriology. All rights reserved.