A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China

International Journal of Infectious Diseases

卷:31

Daniel P. Chin¹  Shitong Huan¹  Junying Chi¹  Yue Jun²  Bing Zhao³  Yang Zhou³  Yang Zheng³  Qiang Li³  Xichao Ou³  Yuanyuan Song³  Hui Xia³  Yu Pang³  Shengfen Wang³  Yanlin Zhao³  Junchen Li⁴  Haiyan Dong⁴  Zhiying Zhang⁴  Jack Zhang⁴  Zhijian Zhang⁵  Kai Man Kam⁶ 

[1] Bill and Melinda Gates Foundation, China Office, Beijing, China;

[2] Department of Clinical Laboratory, Shang Hai Pulmonary Disease Hospital, Shanghai, China;

[3] National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China;

[4] PATH, China Office, Beijing, China;

[5] Respiratory Diseases Department of Nanlou, Chinese People's Liberation Army General Hospital, Beijing, China;

[6] Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China;

关键词: Mycobacterium tuberculosis;    Xpert MTB/RIF;    Rifampin;   

DOI  :  10.1016/j.ijid.2014.09.011

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown