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

Xichao Ou; Hui Xia; Qiang Li; Yu Pang; Shengfen Wang; Bing Zhao; Yuanyuan Song; Yang Zhou; Yang Zheng; Zhijian Zhang; Zhiying Zhang; Junchen Li; Haiyan Dong; Junying Chi; Jack Zhang; Kai Man Kam; Shitong Huan; Yue Jun; Daniel P. Chin; Yanlin Zhao

doi:10.1016/j.ijid.2014.09.011

International Journal of Infectious Diseases (Feb 2015)

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

Xichao Ou,
Hui Xia,
Qiang Li,
Yu Pang,
Shengfen Wang,
Bing Zhao,
Yuanyuan Song,
Yang Zhou,
Yang Zheng,
Zhijian Zhang,
Zhiying Zhang,
Junchen Li,
Haiyan Dong,
Junying Chi,
Jack Zhang,
Kai Man Kam,
Shitong Huan,
Yue Jun,
Daniel P. Chin,
Yanlin Zhao

Affiliations

Xichao Ou: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Hui Xia: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Qiang Li: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Yu Pang: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Shengfen Wang: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Bing Zhao: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Yuanyuan Song: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Yang Zhou: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Yang Zheng: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China
Zhijian Zhang: Respiratory Diseases Department of Nanlou, Chinese People's Liberation Army General Hospital, Beijing, China
Zhiying Zhang: PATH, China Office, Beijing, China
Junchen Li: PATH, China Office, Beijing, China
Haiyan Dong: PATH, China Office, Beijing, China
Junying Chi: Bill and Melinda Gates Foundation, China Office, Beijing, China
Jack Zhang: PATH, China Office, Beijing, China
Kai Man Kam: Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China
Shitong Huan: Bill and Melinda Gates Foundation, China Office, Beijing, China
Yue Jun: Department of Clinical Laboratory, Shang Hai Pulmonary Disease Hospital, Shanghai, China
Daniel P. Chin: Bill and Melinda Gates Foundation, China Office, Beijing, China
Yanlin Zhao: National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China

DOI: https://doi.org/10.1016/j.ijid.2014.09.011
Journal volume & issue: Vol. 31, no. C
pp. 41 – 46

Abstract

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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.

Published in International Journal of Infectious Diseases

ISSN: 1201-9712 (Print); 1878-3511 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Internal medicine: Infectious and parasitic diseases
Website: http://www.journals.elsevier.com/international-journal-of-infectious-diseases/

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