Abstract:

Objective To evaluate value of GenoType MTBDRplus VER 2.0 (MTBDRplus 2.0) technology in rapid detection of Mycobacterium tuberculosis (MTB) and its resistance to rifampicin and isoniazid from sputum samples of suspected pulmonary tuberculosis patients.Methods The results of 1065 suspected pulmonary tuberculosis patients from Xi’an Chest Hospital between January and December 2018 were retrospectively analyzed. Of them, 96 cases of drug-resistant uncertainty and contaminated were excluded, the other 969 suspected patients were included as subjects finally. One sputum specimen collected from each patients was tested by GeneXpert MTB/RIF (GeneXpert), MTBDRplus 2.0, BACTEC MGIT 960 (MGIT 960) liquid culture. and MGIT 960 drug sensitivity test. If the result was positive and MTB was detected, MGIT 960 sensitivity test would be performed. The detection performance of MTBDRplus 2.0 for MTB and drug resistance of rifampicin and isoniazid was assessed according to the MGIT 960 liquid culture and MGIT 960 drug sensitivity test resultst.Results Among the 969 cases, MTB was detected positive by MGIT 960 liquid culture in 409 patients, while negative in 560 cases. Based on the results of MGIT 960 liquid culture, the sensitivity, specificity, Kappa value of MTBDRplus 2.0 were and GeneXpert in the detection of MTB was 91.0% (372/409), 93.8% (525/560) and 0.848, and those of GeneXpert were 92.9% (380/409), 92.5% (518/560) and 0.850, respectively. Based on the MGIT 960 drug sensitivity test results, the sensitivity, specificity and Kappa value of MTBDRplus 2.0 in detection of rifampicin resistance were 89.8% (53/59), 95.8% 295/308) and 0.817, and those of GeneXpert were 91.5% (54/59), 95.8% (295/308) and 0.828, respectively; while the sensitivity, specificity and Kappa value of MTBDRplus 2.0 in detection of isoniazid resistance was 80.4% (82/102), 96.3% (260/270) and 0.791.Conclusion MTBDRplus 2.0 technology is of better performance in detecting MTB from sputum samples of suspected tuberculosis patients, as well as the resistance of rifampicin and isoniazid.

Key words: Mycobacterium tuberculosis, Tuberculosis,multidrug-resistant, Molecular probe techniques, Laboratory techniques and procedures, Comparative study, Data interpretation, statistical