Evaluation of the Xpert MTB/RIF assay for diagnosis of tuberculosis and rifampin resistance in county-level laboratories in Hunan province, China

Chinese Medical Journal

Volumn 127, Issue 21, 2014, Pages 3744-3750

  Hu, Pei Lei ^a   Bai, Li Qiong ^a   Liu, Feng Ping ^a   Ou, Xi Chao ^a   Zhang, Zhi Ying ^b   Yi, Song Lin ^a   Chen, Zhong Nan ^a   Gong, Dao Fang ^a   Liu, Bin Bin ^a   Guo, Jing Wei ^a   Tan, Yun Hong ^a  

^a DEPARTMENT OF HEALTH   (Hong Kong)

^b Chinese Center for Disease Control and Prevention ^*  (China)

Author keywords

Diagnosis; Pulmonary tuberculosis; Rifampin resistance; Xpert MTB RIF

Indexed keywords

RNA POLYMERASE BETA SUBUNIT; RIFAMPICIN; TUBERCULOSTATIC AGENT;

ADULT; ARTICLE; CLINICAL FEATURE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DRUG RESISTANT TUBERCULOSIS; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MYCOBACTERIUM TUBERCULOSIS TEST KIT; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PREDICTIVE VALUE; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; CHINA; MULTIDRUG RESISTANT TUBERCULOSIS; TUBERCULOSIS; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

ADULT; ANTIBIOTICS, ANTITUBERCULAR; CHINA; FEMALE; HUMANS; MALE; MIDDLE AGED; RIFAMPIN; TUBERCULOSIS; TUBERCULOSIS, MULTIDRUG-RESISTANT; TUBERCULOSIS, PULMONARY; YOUNG ADULT;

EID: 84908431149     PISSN: 03666999     EISSN: None     Source Type: Journal    
DOI: 10.3760/cma.j.issn.0366-6999.20141004     Document Type: Article

References (27)

1. World Health Organization. Global tuberculosis report 2013. Geneva: World Health Organization; 2013.
2. World Health Organization. The global plan to stop TB 2011- 2015: transforming the fight towards elimination of tuberculosis. Geneva: World Health Organization; 2010: 34.
3. World Health Organization. Multidrug and extensively drug-resistant TB (M/XDR-TB): 2010 global report on surveillance and response. Geneva: World Health Organization; 2010: 1-2.
4. Small PM, Pai M. Tuberculosis diagnosis — time for a game change. N Engl J Med 2010; 363: 1070-1071.
5. World Health Organization. Policy statement: automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. Geneva: World Health Organization; 2011: 1.
6. Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010; 363: 1005-1015.
7. Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet 2011; 377: 1495-1505.
8. World Health Organization. Rapid implementation of the Xpert MTB/RIF diagnostic test: technical and operational ‘How-to’; practical considerations. Geneva: World Health Organization; 2011: 5-35.
9. Zhao YL, Xu SF, Wang LX, Chin DP, Wang SF, Jiang GL, et al. National survey of drug-resistant tuberculosis in China. N Engl JMed 2012; 366: 2161-2170.
10. China National Health and Family Planning Commission. Diagnostic criteria for pulmonary tuberculosis: WS288-2008. Beijing: People’s Medical Publishing House; 2008: 1.
11. World Health Organization. Treatment of tuberculosis: guidelines. 4th, ed. Geneva: World Health Organization; 2010; 24: 36-37.
12. World Health Organization. Guidelines for surveillance of drug resistance in tuberculosis. 4th edn. Geneva: World Health Organization; 2009: 8-10.
13. Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, et al. Rapid detection of Mycobacterium for tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol 2010; 48: 229-237.
14. Ramirez MV, Cowart KC, Campbell PJ, Morlock GP, Sikes D, Winchell JM, et al. Rapid detection of multidrug-resistant Mycobacterium tuberculosis by use of real-time PCR and high-resolution melt analysis. J Clin Microbiol, 2010; 48: 4003-4009.
15. Newcombe, RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Statist Med 1998; 17: 857-872.
16. Lawn SD, Nicol MP. Xpert MTB/RIF assay: development, evaluation, and implementation of a new rapid molecular diagnostic for tuberculosis and rifampin resistance. Future Microbiol 2011; 6: 1067-1082.
17. Rachow A, Zumla A, Heinrich N, Rojas-Ponce G, Mtafya B, Reither K, et al. Rapid and accurate detection of Mycobacterium tuberculosis in sputum samples by Cepheid Xpert MTB/RIF assay-a clinical validation study. PloS One 2011; 6: 1-8.
18. Rieder HL, Deun AV, Kam KM, Kim SJ, Chonde TM, Trébucq A, et al. Priorities for tuberculosis bacteriology services in low-income countries, 2nd ed. Paris: International Union against Tuberculosis and Lung Disease; 2007: 6-8.
19. Wang HX, Yue J, Han M, Yang JH, Gao RL, Jing LJ, et al. Nontuberculous mycobacteria: susceptibility pattern and prevalence rate in Shanghai from 2005 to 2008. Chin Med J 2010; 123: 184-187.
20. Zhuo FL, Sun ZG, Li CY, Liu ZH, Cai L, Zhou C, et al. Clinical isolates of Mycobacterium abscessus in Guangzhou area most possibly from the environmental infection showed variable susceptibility. Chin Med J 2013; 126: 1878-1883.
21. Blakemore R, Story E, Helb D, Kop J, Banada P, Owens MR, et al. Evaluation of the analytical performance of the Xpert MTB/ RIF assay. J Clin Microbiol 2010; 48: 2495-2501.
22. Trébucq A, Enarson DA, Chiang CY, Van Deun A, Harries AD, Boillot F, et al. Xpert MTB/RIF for national tuberculosis programmes in low-income countries: when, where and how? Int J Tuberc Lung Dis 2011; 15: 1567-1571.
23. Denkinger CM, Nicolau I, Ramsay A, Chedore P, Pai M. Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics? Eur Respir J 2013; 42: 544-547.
24. Ou XL, Xia H, Li Q, Pang Y, Zhao B, Zhang ZY, et al. Cost analysis of Xpert MTB/RIF for the detection of Mycobacterium tuberculosis and rifampin resistance (in Chinese). Chin J Antituberc 2013; 35: 723-728.
25. World Health Organization. Tuberculosis laboratory biosafety manual. Geneva: World Health Organization; 2012: 20-23.
26. Van Rie A, Page-Shipp L, Scott L, Sanne I, Stevens W. Xpert(®) MTB/RIF for point-of-care diagnosis of TB in high-HIV burden, resource-limited countries: hype or hope? Expert Rev Mol Diagn 2010; 10: 937-946.
27. Evans CA. GeneXpert — a game-changer for tuberculosis control? PLoS Med 2011; 8: e1001064.