title: Multicenter evaluation of a real-time loop-mediated isothermal amplification (RealAmp) test for rapid diagnosis of Mycobacterium tuberculosis.
abstract: The real-time loop-mediated isothermal amplification (RealAmp) test is a novel technology for rapid diagnosis of Mycobacterium tuberculosis (MTB) from sputum samples. This test has not previously been effectively evaluated. In this study, we assessed the performance of the RealAmp test for tuberculosis (TB) detection among TB suspected patients from three provincial hospitals in China. Each eligible TB suspected patients in Shanghai, Guangzhou, and Shandong provided one sputum specimen each, smear microscopy, liquid culture, and the RealAmp test were performed per patient. A total of 1583 TB suspected patients were enrolled in the study, and 1519 were used for the performance analysis. The sensitivity and specificity of the RealAmp test for MTB detection were calculated using liquid culture as reference method. The sensitivity of RealAmp test in smear-negative and culture-positive patients was 60.08%; the sensitivity in smear-positive and culture-positive patients was 97.09%; and the overall sensitivity in culture-positive patients was 74.88%. The specificity of RealAmp test for MTB detection was 86.50%.
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: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Shengfen
authors.initials: S
authors.lastname: Wang
authors.affiliation: PATH, China Office, Beijing, China.
authors.forename: Haiyan
authors.initials: H
authors.lastname: Dong
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: 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: 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: Yan
authors.initials: Y
authors.lastname: Qu
authors.affiliation: PATH, China Office, Beijing, China.
authors.forename: Zhiying
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: PATH, China Office, Beijing, China.
authors.forename: Junchen
authors.initials: J
authors.lastname: Li
authors.affiliation: PATH, China Office, Beijing, China.
authors.forename: Jack
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Bill & Melinda Gates Foundation, China Office, Beijing, China.
authors.forename: Shitong
authors.initials: S
authors.lastname: Huan
authors.affiliation: Bill & Melinda Gates Foundation, China Office, Beijing, China.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Chin
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: zhaoyanlin@chinatb.org.
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D002681:China; D005260:Female; D006801:Humans; D008297:Male; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
keywords: Mycobacterium tuberculosis; RealAmp; Sensitivity; Specificity