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  • Title: Evaluation of the GenoType(®) MTBDRplus line probe assay on sputum-positive samples in routine settings in China.
    Author: Chen C, Kong W, Zhu L, Zhou Y, Peng H, Shao Y, Song H, Liu Q, Li G, Shi J, Zhong C, Zhu L, Ding X, Yu H, Yang H, Lu W.
    Journal: Int J Tuberc Lung Dis; 2014 Sep; 18(9):1034-9. PubMed ID: 25189549.
    Abstract:
    BACKGROUND: Rapid molecular methods have been recommended for early detection of drug-resistant tuberculosis (TB). OBJECTIVE: To evaluate the performance of the GenoType(®) MTBDRplus assay in routine settings in China. METHODS: Sputum-positive samples were collected consecutively from 1 April to 31 December 2010. MTBDRplus results were compared to those of conventional drug susceptibility testing (DST). The McNemar χ(2) test and κ coefficient were used to assess performance. RESULTS: Of 427 smear-positive sputum samples collected, conventional DST and MTBDTplus confirmed drug resistance in 326. The sensitivities and specificities for MTBDRplus in detecting isoniazid (INH) and rifampicin (RMP) resistance were respectively 76.47%, 95.44%, 85.94% and 93.13%. The McNemar χ(2) test indicated no significant difference between the two methods (P = 0.106 for INH and P = 0.083 for RMP). The κ values for INH, RMP and multidrug resistance were respectively 0.75, 0.75 and 0.70. CONCLUSIONS: Although the MTBDRplus assay was moderately concordant with conventional DST in detecting INH and RMP resistance, as a prospective rapid molecular method for MDR-TB detection, potential resistant mutations need to be incorporated to improve the accuracy of detection.
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