Do high rates of empirical treatment undermine the potential effect of new diagnostic tests for tuberculosis in high-burden settings?

The Lancet Infectious Diseases

Volumn 14, Issue 6, 2014, Pages 527-532

  Theron, Grant ^a   Peter, Jonny ^a   Dowdy, David ^c   Langley, Ivor ^d   Squire, S Bertel ^d   Dheda, Keertan ^a,b  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

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

^d LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIUM CULTURE; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DIAGNOSTIC ACCURACY; DISEASE TRANSMISSION; EARLY DIAGNOSIS; HEALTH CARE; HEALTH CARE COST; HEALTH CARE POLICY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; META ANALYSIS (TOPIC); MICROBIOLOGICAL EXAMINATION; MICROSCOPY; MORBIDITY; MORTALITY; NOTE; POLYMERASE CHAIN REACTION SYSTEM; PREVALENCE; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SPUTUM SMEAR; THORAX RADIOGRAPHY; TIME TO TREATMENT; TUBERCULOSIS; XPERT MTB RIF SYSTEM;

ANTIBIOTICS, ANTITUBERCULAR; ANTITUBERCULAR AGENTS; DRUG RESISTANCE, BACTERIAL; HUMANS; MYCOBACTERIUM TUBERCULOSIS; POINT-OF-CARE SYSTEMS; REAL-TIME POLYMERASE CHAIN REACTION; RIFAMPIN; SENSITIVITY AND SPECIFICITY; SPECIES SPECIFICITY; TIME FACTORS; TUBERCULOSIS;

EID: 84901058039     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(13)70360-8     Document Type: Note

References (38)

1. Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. Geneva 2010, WHO, World Health Organization, Geneva.
2. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. Publication number: WHO/HTM/TB/2011.4 2011, WHO, World Health Organization, Geneva.
3. From data to scale-up: building the evidence base for new tuberculosis diagnostics. Union World Conference on Lung Health in Kuala Lumpur, Malaysia 2012, WHO, World Health Organization, Geneva.
4. Theron G, Zijenah L, Chanda D, et al. 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. Lancet 2013, for the TB-NEAT team, published online Oct 28. http://dx.doi.org/10.1016/S0140-6736(13)62073-5.
5. Dheda K, Ruhwald M, Theron G, Peter J, Yam WC Point-of-care diagnosis of tuberculosis: past, present and future. Respirology 2013, 18:217-232.
6. 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.
7. Pantoja A, Fitzpatrick C, Vassall A, Weyer K, Floyd K Xpert MTB/RIF for diagnosis of TB and drug-resistant TB: a cost and affordability analysis. Eur Respir J 2013, 42:708-720.
8. Keeler E, Perkins MD, Small P, et al. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature 2006, 444:49-57.
9. Hargreaves NJ, Kadzakumanja O, Whitty CJM, Salaniponi FML, Harries AD, Squire SB Smear-negative pulmonary tuberculosis in a DOTS programme: poor outcomes in an area of high HIV seroprevalence. Int J Tuberc Lung Dis 2001, 5:847-854.
10. Lawn S, Ayles H, Egwaga S, et al. Potential utility of empirical tuberculosis treatment for HIV-infected patients with advanced immunodeficiency in high TB-HIV burden settings. Int J Tuberc Lung Dis 2011, 15:287-295.
11. Peter JG, Theron G, van Zyl-Smit R, et al. Diagnostic accuracy of a urine LAM strip-test for TB detection in HIV-infected hospitalised patients. Eur Respir J 2012, 40:1211-1220.
12. Peter JG, Theron G, Singh N, Singh A, Dheda K Sputum induction to aid the diagnosis of smear-negative or sputum-scarce TB in adults from a HIV-endemic setting. Eur Respir J 2013, published online March 21. 10.1183/09031936.00198012.
13. 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, 1:447-471.
14. Improving the diagnosis and treatment of smear-negative pulmonary and extrapulmonary tuberculosis among adults and adolescents 2006, WHO, World Health Organization, Geneva.
15. Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infect Dis 2013, 13:507.
16. Alamo ST, Kunutsor S, Walley J, et al. Performance of the new WHO diagnostic algorithm for smear-negative pulmonary tuberculosis in HIV prevalent settings: a multisite study in Uganda. Trop Med Int Health 2012, 17:884-895.
17. Huerga H, Varaine F, Okwaro E, et al. Performance of the 2007 WHO algorithm to diagnose smear-negative pulmonary tuberculosis in a HIV prevalent setting. PLoS One 2012, 7:e51336.
18. Soto A, Solari L, Gotuzzo E, Acinelli R, Vargas D, Van der Stuyft P Performance of an algorithm based on WHO recommendations for the diagnosis of smear-negative pulmonary tuberculosis in patients without HIV infection. Trop Med Int Health 2011, 16:424-430.
19. Walley J, Kunutsor S, Evans M, et al. Validation in Uganda of the new WHO diagnostic algorithm for smear-negative pulmonary tuberculosis in HIV prevalent settings. J Acquir Immune Defic Syndr 2011, 57:e93-100.
20. Wilson D, Mbhele L, Badri M, et al. Evaluation of the World Health Organization algorithm for the diagnosis of HIV-associated sputum smear-negative tuberculosis. Int J Tuberc Lung Dis 2011, 15:919-924.
21. Nakiyingi L, Bwanika JM, Kirenga B, et al. Clinical Predictors and Accuracy of Empiric Tuberculosis Treatment among Sputum Smear-Negative HIV-Infected Adult TB Suspects in Uganda. PLoS One 2013, 8:e74023.
22. Cohen T, Murray M, Wallengren K, Alvarez GG, Samuel EY, Wilson D The prevalence and drug sensitivity of tuberculosis among patients dying in hospital in KwaZulu-Natal, South Africa: a postmortem study. PLoS Med 2010, 7:e1000296.
23. Chang KC, Leung CC, Yew WW, Tam CM Supervised and induced sputum among patients with smear-negative pulmonary tuberculosis. Eur Respir J 2008, 31:1085-1090.
24. Peter JG, Theron G, Dheda K Can point-of-care urine LAM strip testing for tuberculosis add value to clinical decision making in hospitalised HIV-infected persons?. PLoS One 2013, 8:e54875.
25. 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, 377:1450-1495.
26. Hanrahan CF, Selibas K, Deery CB, 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.
27. 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, 68:1043-1051.
28. Winetsky DE, Negoescu DM, DeMarchis EH, et al. Screening and rapid molecular diagnosis of tuberculosis in prisons in Russia and Eastern Europe: a cost-effectiveness analysis. PLoS Med 2012, 9:e1001348.
29. 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.
30. Andrews JR, Lawn SD, Rusu C, et al. The cost-effectiveness of routine tuberculosis screening with Xpert MTB/RIF prior to initiation of antiretroviral therapy: a model-based analysis. AIDS 2012, 26:987.
31. 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.
32. WHO report 2011: global tuberculosis control 2011, WHO, World Health Organization, Geneva.
33. Lin H-H, Langley I, Mwenda R, et al. A modelling framework to support the selection and implementation of new tuberculosis diagnostic tools. Int J Tuberc Lung Dis 2011, 15:996-1004.
34. Tuberculosis Country profiles: United Republic of Tanzania WHO, (accessed Dec 5, 2013). https://extranet.who.int/sree/Reports?op=Replet&name=%2FWHO_HQ_Reports%2FG2%2FPROD%2FEXT%2FTBCountryProfile&ISO2=TZ&LAN=EN&outtype=html.
35. Langley I, Doulla B, Lin H-H, Millington K, Squire B Modelling the impacts of new diagnostic tools for tuberculosis in developing countries to enhance policy decisions. Health Care Manag Sci 2012, 15:1-15.
36. Theron G, Pooran A, Peter J, et al. Do adjunct TB tests, when combined with Xpert MTB/RIF, improve accuracy and the cost of diagnosis in a resource-poor setting?. Eur Respir J 2012, 40:161-168.
37. Kapata N, Chanda-Kapata P, Bates M, et al. Multidrug-resistant TB in Zambia: review of national data from 2000 to 2011. Trop Med Int Health 2013, published online Sep 11. 10.1111/tmi.12183.
38. Trébucq A, Enarson D, Chiang C, et al. Xpert® MTB/RIF for national tuberculosis programmes in low-income countries: when, where and how?. Int J Tuberc Lung Dis 2011, 15:1567-1572.