Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China

Scientific Reports - Tập 6 Số 1
Yu Pang1, Haiyan Dong2, Yi Tan3, Yunfeng Deng4, Xingshan Cai3, Hui Jing4, Hui Xia1, Qiang Li1, Xichao Ou1, Biyi Su3, Xuezheng Li4, Zhiying Zhang2, Junchen Li2, Jiankang Zhang2, Shitong Huan5, Yanlin Zhao1
1National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
2PATH, Beijing, China
3Department of Clinical Laboratory, Guangzhou Chest Hospital, Guangdong Province, Guangzhou, China
4Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Provincial Chest Hospital, Jinan, China
5Bill and Melinda Gates Foundation, China Office, Beijing, China

Tóm tắt

AbstractNew diagnostic methods have provided a promising solution for rapid and reliable detection of drug-resistant TB strains. The aim of this study was to evaluate the performance of the MeltPro TB assay in identifying multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) patients from sputum samples. The MeltPro TB assay was evaluated using sputum samples from 2057 smear-positive TB patients. Phenotypic Mycobacterial Growth Indicator Tube (MGIT) 960 drug susceptibility testing served as a reference standard. The sensitivity of the MeltPro TB assay was 94.2% for detecting resistance to rifampicin and 84.9% for detecting resistance to isoniazid. For second-line drugs, the assay showed a sensitivity of 83.3% for ofloxacin resistance, 75.0% for amikacin resistance, and 63.5% for kanamycin resistance. However, there was a significant difference for detecting kanamycin resistance between the two pilot sites in sensitivity, which was 53.2% in Guangdong and 81.5% in Shandong (P = 0.015). Overall, the MeltPro TB assay demonstrated good performance for the detection of MDR- and XDR-TB, with a sensitivity of 86.7% and 71.4%, respectively. The MeltPro TB assay is an excellent alternative for the detection of MDR- and XDR-TB cases in China, with high accuracy, short testing turn-around time, and low unit price compared with other tests.

Từ khóa


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