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

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

Int J Infect Dis. 2015 Feb:31:41-6. doi: 10.1016/j.ijid.2014.09.011. Epub 2014 Oct 30.

Authors

Xichao Ou¹, Hui Xia¹, Qiang Li¹, Yu Pang¹, Shengfen Wang¹, Bing Zhao¹, Yuanyuan Song¹, Yang Zhou¹, Yang Zheng¹, Zhijian Zhang², Zhiying Zhang³, Junchen Li³, Haiyan Dong³, Junying Chi⁴, Jack Zhang³, Kai Man Kam⁵, Shitong Huan⁴, Yue Jun⁶, Daniel P Chin⁷, Yanlin Zhao⁸

Affiliations

¹ National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, No. 155, Changbai Road, Beijing, China.
² Respiratory Diseases Department of Nanlou, Chinese People's Liberation Army General Hospital, Beijing, China.
³ PATH, China Office, Beijing, China.
⁴ Bill and Melinda Gates Foundation, China Office, Beijing, China.
⁵ Stanley Ho Centre for Emerging Infectious Diseases, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China.
⁶ Department of Clinical Laboratory, Shang Hai Pulmonary Disease Hospital, Shanghai, China.
⁷ Bill and Melinda Gates Foundation, China Office, Beijing, China. Electronic address: daniel.chin@gatesfoundation.org.
⁸ 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.

PMID: 25447720
DOI: 10.1016/j.ijid.2014.09.011

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.

Keywords: Mycobacterium tuberculosis; Rifampin; Xpert MTB/RIF.

Publication types

Evaluation Study
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

China
Clinical Laboratory Techniques
Drug Resistance, Bacterial
Feasibility Studies
Female
Humans
Male
Mycobacterium tuberculosis / isolation & purification*
Real-Time Polymerase Chain Reaction*
Rifampin / pharmacology
Sensitivity and Specificity
Tuberculosis, Multidrug-Resistant / diagnosis
Tuberculosis, Pulmonary / diagnosis*

Substances

Rifampin