Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: A multicentre, randomised, controlled trial

The Lancet

Volumn 383, Issue 9915, 2014, Pages 424-435

  Theron, Grant ^a   Zijenah, Lynn ^d   Chanda, Duncan ^e   Clowes, Petra ^f,g   Rachow, Andrea ^g,h   Lesosky, Maia ^a   Bara, Wilbert ⁱ   Mungofa, Stanley ⁱ   Pai, Madhukar ^j   Hoelscher, Michael ^g,h   Dowdy, David ^k   Pym, Alex ^l,m   Mwaba, Peter ^e   Mason, Peter ⁿ   Peter, Jonny ^a   Dheda, Keertan ^a,b,c  

^a Department of Medicine   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c UNIVERSITY OF CAPE TOWN   (South Africa)

^d UNIVERSITY OF ZIMBABWE   (Zimbabwe)

^e UNIVERSITY TEACHING HOSPITAL   (Zambia)

^f NATIONAL INSTITUTE OF MEDICAL RESEARCH   (Tanzania)

^g LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^h German Centre for Infection Research (DZIF)   (Germany)

ⁱ Harare City Health   (Zimbabwe)

^j MCGILL UNIVERSITY   (Canada)

^k JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^l SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^m AFRICA HEALTH RESEARCH INSTITUTE   (South Africa)

ⁿ BIOMEDICAL RESEARCH AND TRAINING INSTITUTE   (Zimbabwe)

more..

Author keywords

[No Author keywords available]

Indexed keywords

RIFAMPICIN;

ACCURACY; ADULT; ARTICLE; ASSAY; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIAGNOSTIC KIT; FEASIBILITY STUDY; FEMALE; HEALTH CARE FACILITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KARNOFSKY PERFORMANCE STATUS; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MICROSCOPY; MIDDLE AGED; MORBIDITY; MULTICENTER STUDY; MYCOBACTERIUM TUBERCULOSIS; NUCLEIC ACID AMPLIFICATION; PARALLEL DESIGN; POINT OF CARE TESTING; PREVALENCE; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOUTH AFRICA; SPUTUM SMEAR; TANZANIA; TUBERCULOSIS; XPERT MTB/RIF ASSAY; YOUNG ADULT; ZAMBIA; ZIMBABWE;

EID: 84895071180     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(13)62073-5     Document Type: Article

References (40)

1. WHO. Monitoring achievement of the health-related Millennium Development Goals. Geneva: World Health Organization, 2008. http://apps.who.int/gb/ebwha/ pdf-files/WHA66/A66-13-en.pdf (accessed Oct 8, 2013).
2. Raviglione M, Marais B, Floyd K., et al Scaling up interventions to achieve global tuberculosis control: progress and new developments. Lancet 2012; 379: 1902-13.
3. WHO. Global tuberculosis control report, 2012. Publication number WHO/HTM/TB/2012.6. Geneva: World Health Organization, 2013.
4. Stuckler D, Basu S, McKee M. Drivers of inequality in Millennium Development Goal progress: a statistical analysis. PLoS Med 2010; 7: e1000241.
5. Getahun H, Harrington M, O'Brien R, Nunn P. Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet 2007; 369: 2042-49.
6. Dowdy DW, Chaisson RE, Moulton L.H., Dorman SE The potential impact of enhanced diagnostic techniques for tuberculosis driven by HIV: a mathematical model. AIDS 2006; 20: 751-62.
7. Lin H-H, Dowdy D., Dye C, Murray M, Cohen T. The impact of new tuberculosis diagnostics on transmission: why context matters. Bull World Health Organ 2012; 90: 739-747A.
8. Boehme CC, Nicol MP, Nabeta P, 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: 1495-505.
9. WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resitance: Xpert MTB/RIF SYSTEM. Publication number WHO/HTM/TB/2011.4. Geneva: World Health Organization, 2011.
10. WHO. Implementation and roll-out of Xpert MTB/RIF, May 2013. Update from the STOP TB Department. Geneva: World Health Organization, 2013.
11. Steingart KR, Sohn H, Schiller I., et al Xpert MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev 2013; 1: CD009593.
12. Lawn SD, Brooks SV, Kranzer K, et al Screening for HIV-associated tuberculosis and rifampicin resistance before antiretroviral therapy using the Xpert MTB/RIF assay: a prospective study. PLoS Med 2011; 8: e1001067.
13. Van Rie A., Page-Shipp L, Hanrahan C.F., et al Point-of-care Xpert MTB/RIF for smear-negative tuberculosis suspects at a primary care clinic in South Africa. Int J Tuberc Lung Dis 2013; 17: 368-72.
14. Yoon C, Cattamanchi A, Davis J.L., et al Impact of Xpert MTB/RIF testing on tuberculosis management and outcomes in hospitalized patients in Uganda. PLoS One 2012; 7: e48599.
15. Vassall A, van Kampen S, Sohn H, et al Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis. PLoS Med 2011; 8: e1001120.
16. Menzies NA, Cohen T, Lin H-H, Murray M, Salomon JA Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation. PLoS Med 2012; 9: e1001347.
17. Hanrahan CF, Selibas K, Deery C.B., et al Time to treatment and patient outcomes among TB suspects screened by a single point-of-care xpert MTB/RIF at a primary care clinic in Johannesburg, South Africa. PLoS One 2013; 8: e65421.
18. Clouse K, Page-Shipp L, Dansey H., et al Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level. S Afr Med J 2012; 102: 805-07.
19. Squire SB, Belaye AK, Kashoti A, et al 'Lost' smear-positive pulmonary tuberculosis cases: where are they and why did we lose them? Int J Tuberc Lung Dis 2005; 9: 25-31.
20. Botha E, Den Boon S, Verver S, et al Initial default from tuberculosis treatment: how often does it happen and what are the reasons? Int J Tuberc Lung Dis 2008; 12: 820-23.
21. Aderaye G. Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents: recommendations for HIV-prevalent and resource-constrained settings. Geneva: World Health Organization, 2007.
22. Zwarenstein M, Treweek S, Gagnier J.J., et al Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337: a2390.
23. Boehme CC, Nabeta P, Hillemann D., et al Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 2010; 363: 1005-15.
24. WHO. Definitions of tuberculosis cases and treatment outcomes. Geneva: World Health Organization, 2013. http://www.who.int/tb/publications/global- report/2008/table-a2-1/en/index.html (accessed Oct 8, 2013).
25. Wejse C, Gustafson P, Nielsen J., et al TBscore: signs and symptoms from tuberculosis patients in a low-resource setting have predictive value and may be used to assess clinical course. Scand J Infect Dis 2008; 40: 111-20.
26. Wejse C, Gomes VF, Rabna P, et al Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med 2009; 179: 843-50.
27. Wilson D, Nachega J, Morroni C., Chaisson R, Maartens G. Diagnosing smear-negative tuberculosis using case definitions and treatment response in HIV-infected adults. Int J Tuberc Lung Dis 2006; 10: 31-38.
28. Rudolf F, Joaquim LC, Vieira C, et al The Bandim tuberculosis score: reliability and comparison with the Karnofsky performance score. Scand J Infect Dis 2013; 45: 256-64.
29. Fleiss JLLB, Paik MC Statistical methods for rates and proportions, third edn. London: John Wiley & Sons, 2003: 598-626.
30. Dean AGSK, Soe MM OpenEpi: open source epidemiologic statistics for public health, version 2.3.1. www.openepi.com (accessed Oct 8, 2013).
31. *Power 3.1: tests for correlation and regression analyses. Behav Res Methods 2009; 41: 1149-60.
32. Development Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing, 2005.
33. Chang K, Lu W, Wang J., et al Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. J Infect 2012; 64: 580-88.
34. Theron G, Peter J, Meldau R., et al Accuracy and impact of Xpert MTB/RIF for the diagnosis of smear-negative or sputum-scarce tuberculosis using bronchoalveolar lavage fluid. Thorax 2013; published online June 13. DOI:10.1136/thoraxjnl-2013-203485.
35. Meyer-Rath G., Schnippel K, Long L., et al The impact and cost of scaling up GeneXpert MTB/RIF in South Africa. PLoS One 2012; 7: e36966.
36. Pai NP, Vadnais C, Denkinger C., Engel N, Pai M. Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low- and middle-income countries. PLoS Med 2012; 9: e1001306.
37. Lawn SD, Kerkhoff AD, Wood R. Location of Xpert MTB/RIF in centralised laboratories in South Africa undermines potential impact. Int J Tuberc Lung Dis 2012; 16: 701.
38. Moons KG, Biesheuvel CJ, Grobbee DE Test research versus diagnostic research. Clin Chem 2004; 50: 473-76.
39. Dowdy DW, Cattamanchi A, Steingart K.R., Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med 2011; 8: e1001063.
40. Peter JG, Theron G, Pooran A., Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respir Med 2013; 1: 471-78.