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Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
Published on: April 9, 2012
Evaluation of the GenoType(®) MTBDRplus line probe assay on sputum-positive samples in routine settings in China
1Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China; School of Public Health, Fudan University, Shanghai, China.
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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