title: Multicenter Evaluation of the Molecular Line Probe Assay for Multidrug Resistant Mycobacterium Tuberculosis Detection in China.
abstract: In order to evaluate the performance of a molecular Hain line probe assay (Hain LPA) for rapid detection of rifampicin and isoniazid resistance of Mycobacterium tuberculosis in China, 1612 smear positive patients were consecutively enrolled in this study. Smear positive sputum specimens were collected for Hain LPA and conventional drug susceptibility testing (DST). The sensitivity and specificity of Hain LPA were analyzed by using conventional DST as golden reference. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rifampicin resistance detection were 88.33%, 97.66%, 81.54%, and 98.62%, respectively. The sensitivity, specificity, PPV and NPV for isoniazid resistance detection were 80.25%, 98.07%, 87.25%, and 96.78%, respectively. These findings suggested that Hain LPA can be an effective method worthy of broader use in China.
authors.affiliation: National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: PATH Beijing Office, Beijing 100600, China.
authors.forename: Hai Yan
authors.initials: HY
authors.lastname: Dong
authors.affiliation: National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Pang
authors.affiliation: National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Xia
authors.affiliation: National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Xi Chao
authors.initials: XC
authors.lastname: Ou
authors.affiliation: PATH Beijing Office, Beijing 100600, China.
authors.forename: Zhi Ying
authors.initials: ZY
authors.lastname: Zhang
authors.affiliation: PATH Beijing Office, Beijing 100600, China.
authors.forename: Jun Chen
authors.initials: JC
authors.lastname: Li
authors.affiliation: PATH Beijing Office, Beijing 100600, China.
authors.forename: Jian Kang
authors.initials: JK
authors.lastname: Zhang
authors.affiliation: Gates Foundation Beijing Office, Beijing 100600, China.
authors.forename: Shi Tong
authors.initials: ST
authors.lastname: Huan
authors.affiliation: Gates Foundation Beijing Office, Beijing 100600, China.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Chin
authors.affiliation: Chinese University of HongKong, HongKong 649490, China.
authors.forename: Kai Man
authors.initials: KM
authors.lastname: Kam
authors.affiliation: National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Yan Lin
authors.initials: YL
authors.lastname: Zhao
mesh_terms: D002681:China; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000235:genetics* / Q000302:isolation & purification; D012293:Rifampin / Q000494:pharmacology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis / Q000382:microbiology*
chemical_list: D007538:Isoniazid; D012293:Rifampin