title: A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China.
abstract: OBJECTIVE
  To evaluate the performance of Xpert MTB/RIF (MTB/RIF) in the county-level tuberculosis (TB) laboratory in China.
  
  
  METHODS
  From April 2011 to January 2012, patients with suspected multidrug-resistant tuberculosis (MDR-TB) and non-MDR-TB were enrolled consecutively from four county-level TB laboratories. The detection of Mycobacterium tuberculosis (MTB) by MTB/RIF was compared to detection by Löwenstein-Jensen culture. The detection of rifampin resistance was compared to detection by conventional drug-susceptibility testing. The impact of multiple specimens on the performance of MTB/RIF was also evaluated.
  
  
  RESULTS
  A total of 2142 suspected non-MDR-TB cases and 312 suspected MDR-TB cases were enrolled. For MTB detection in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 94.4% and 90.2%, respectively. The sensitivity in smear-negative patients was 88.8%. For the detection of rifampin resistance in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 97.9%, respectively. For the detection of rifampin resistance in suspected MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 91.0%, respectively. Using multiple sputum specimens had no significant influence on the performance of MTB/RIF for MTB detection.
  
  
  CONCLUSIONS
  The introduction of MTB/RIF could increase the accuracy of detection of MTB and rifampin resistance in peripheral-level TB laboratories in China. One single specimen is adequate for TB diagnosis by MTB/RIF.
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, 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, No. 155, Changbai Road, 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, No. 155, Changbai Road, 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, No. 155, Changbai Road, 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, No. 155, Changbai Road, Beijing, China.
authors.forename: Shengfen
authors.initials: S
authors.lastname: Wang
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Zhao
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China.
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Song
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Respiratory Diseases Department of Nanlou, Chinese People's Liberation Army General Hospital, Beijing, China.
authors.forename: Zhijian
authors.initials: Z
authors.lastname: Zhang
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: Haiyan
authors.initials: H
authors.lastname: Dong
authors.affiliation: Bill and Melinda Gates Foundation, China Office, Beijing, China.
authors.forename: Junying
authors.initials: J
authors.lastname: Chi
authors.affiliation: PATH, China Office, Beijing, China.
authors.forename: Jack
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Kai Man
authors.initials: KM
authors.lastname: Kam
authors.affiliation: Bill and Melinda Gates Foundation, China Office, Beijing, China.
authors.forename: Shitong
authors.initials: S
authors.lastname: Huan
authors.affiliation: Department of Clinical Laboratory, Shang Hai Pulmonary Disease Hospital, Shanghai, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Jun
authors.affiliation: Bill and Melinda Gates Foundation, China Office, Beijing, China. Electronic address: daniel.chin@gatesfoundation.org.
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, No. 155, Changbai Road, Beijing, China. Electronic address: zhaoyanlin@chinatb.org.
authors.forename: Yanlin
authors.initials: Y
authors.lastname: Zhao
mesh_terms: D002681:China; D019411:Clinical Laboratory Techniques; D024881:Drug Resistance, Bacterial; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D060888:Real-Time Polymerase Chain Reaction; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*
chemical_list: D012293:Rifampin
keywords: Mycobacterium tuberculosis; Rifampin; Xpert MTB/RIF