Validation of the GenoType MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam.
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 MTBDRplus 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 MTBDRplus 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 MTBDRplus 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 MTBDRplus 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 MTBDRplus test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.
KNCV Tuberculosis Foundation, PO Box 146, 2501CC The Hague, The Netherlands.
Mai N T
MN
Huyen
Edine W
EW
Tiemersma
Nguyen T N
NT
Lan
Frank G J
FG
Cobelens
Nguyen H
NH
Dung
Dinh N
DN
Sy
Tran N
TN
Buu
Kristin
K
Kremer
Pham T
PT
Hang
Maxine
M
Caws
Richard
R
O'Brien
Dick
D
van Soolingen
D000995:Antitubercular Agents / Q000494:pharmacology; D004269:DNA, Bacterial / Q000235:genetics*; D024901:Drug Resistance, Multiple, Bacterial; D005838:Genotype; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology; D008826:Microbial Sensitivity Tests; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000302:isolation & purification; D011237:Predictive Value of Tests; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology; D014744:Vietnam
D000995:Antitubercular Agents; D004269:DNA, Bacterial; D007538:Isoniazid; D012293:Rifampin