title: Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China.
abstract: New 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.
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Pang
authors.affiliation: PATH, Beijing, China.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Dong
authors.affiliation: Department of Clinical Laboratory, Guangzhou Chest Hospital, Guangdong Province, Guangzhou, China.
authors.forename: Yaoju
authors.initials: Y
authors.lastname: Tan
authors.affiliation: Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Provincial Chest Hospital, Jinan, China.
authors.forename: Yunfeng
authors.initials: Y
authors.lastname: Deng
authors.affiliation: Department of Clinical Laboratory, Guangzhou Chest Hospital, Guangdong Province, Guangzhou, China.
authors.forename: Xingshan
authors.initials: X
authors.lastname: Cai
authors.affiliation: Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Provincial Chest Hospital, Jinan, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Jing
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Xia
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Xichao
authors.initials: X
authors.lastname: Ou
authors.affiliation: Department of Clinical Laboratory, Guangzhou Chest Hospital, Guangdong Province, Guangzhou, China.
authors.forename: Biyi
authors.initials: B
authors.lastname: Su
authors.affiliation: Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Provincial Chest Hospital, Jinan, China.
authors.forename: Xuezheng
authors.initials: X
authors.lastname: Li
authors.affiliation: PATH, Beijing, China.
authors.forename: Zhiying
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: PATH, Beijing, China.
authors.forename: Junchen
authors.initials: J
authors.lastname: Li
authors.affiliation: PATH, Beijing, China.
authors.forename: Jiankang
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Bill and Melinda Gates Foundation, China Office, Beijing, China.
authors.forename: Shitong
authors.initials: S
authors.lastname: Huan
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D000583:Amikacin / Q000494:pharmacology; D002681:China; D054908:Extensively Drug-Resistant Tuberculosis / Q000175:diagnosis*; D006801:Humans; D007612:Kanamycin / Q000494:pharmacology; D008826:Microbial Sensitivity Tests / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000187:drug effects*; D015242:Ofloxacin / Q000494:pharmacology; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis*
chemical_list: D007612:Kanamycin; D000583:Amikacin; D015242:Ofloxacin; D012293:Rifampin