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Background  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 plus  test is a commercially available line-probe assay that rapidly detects  Mycobacterium tuberculosis  (MTB) complex, as well as the most common mutations associated with rifampin and isoniazid resistance.  We assessed sensitivity and specificity of the assay by using a geographically representative set of MTB isolates from the South of Vietnam.    Methods  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 plus  test.    Results  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 plus  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 plus  test for MDR-TB was 100% and the negative predictive value 90.3%.    Conclusions  We found a high specificity and positive predictive value of the GenoType ®  MTBDR plus  test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.

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