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Comparative Study
. 2014 Feb;18(2):233-9.
doi: 10.5588/ijtld.13.0468.

Performance of the MTBDRsl assay in Georgia

N Tukvadze  1 , N Bablishvili  1 , R Apsindzelashvili  1 , H M Blumberg  2 , R R Kempker  2
Affiliations
Comparative Study

Performance of the MTBDRsl assay in Georgia

N Tukvadze et al. Int J Tuberc Lung Dis. 2014 Feb.

Abstract

Setting: The country of Georgia has a high burden of multi- (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).

Objective: To assess the performance of the GenoType® MTBDRsl assay in the detection of resistance to kanamycin (KM), capreomycin (CPM) and ofloxacin (OFX), and of XDR-TB.

Design: Consecutive acid-fast bacilli smear-positive sputum specimens identified as MDR-TB using the MTBDRplus test were evaluated with the MTBDRsl assay and conventional second-line drug susceptibility testing (DST).

Results: Among 159 specimens, amplification was adequate in 154 (97%), including 9 of 9 culture-negative and 2 of 3 contaminated specimens. Second-line DST revealed that 17 (12%) Mycobacterium tuberculosis isolates were XDR-TB. Compared to DST, the MTBDRsl had 41% sensitivity and 98% specificity in detecting XDR-TB and 81% sensitivity and 99% specificity in detecting OFX resistance. Sensitivity was low in detecting resistance to KM (29%) and CPM (57%), while specificity was respectively 99% and 94%. Median times from sputum collection to second-line DST and MTBDRsl results were 70-104 vs. 10 days.

Conclusion: Although the MTBDRsl assay had a rapid turnaround time, detection of second-line drug resistance was poor compared to DST. Further genetic mutations associated with resistance to second-line drugs should be included in the assay to improve test performance and clinical utility.

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Conflict of interest statement

The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Sputum culture results for all AFB smear positive tuberculosis suspects and corresponding complete MTBDRsl assay results
Figure 2
Figure 2
Distribution of MTBDRsl assay results according to phenotypic drug-resistance patterns using conventional drug susceptibility testing
See this image and copyright information in PMC

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