Serological Testing Versus Other Strategies for Diagnosis of Active Tuberculosis in India: A Cost-Effectiveness Analysis

English version České info

Background:
Undiagnosed and misdiagnosed tuberculosis (TB) drives the epidemic in India. Serological (antibody detection) TB tests are not recommended by any agency, but widely used in many countries, including the Indian private sector. The cost and impact of using serology compared with other diagnostic techniques is unknown.

Methods and Findings:
Taking a patient cohort conservatively equal to the annual number of serological tests done in India (1.5 million adults suspected of having active TB), we used decision analysis to estimate costs and effectiveness of sputum smear microscopy (US$3.62 for two smears), microscopy plus automated liquid culture (mycobacterium growth indicator tube [MGIT], US$20/test), and serological testing (anda-tb ELISA, US$20/test). Data on test accuracy and costs were obtained from published literature. We adopted the perspective of the Indian TB control sector and an analysis frame of 1 year. Our primary outcome was the incremental cost per disability-adjusted life year (DALY) averted. We performed one-way sensitivity analysis on all model parameters, with multiway sensitivity analysis on variables to which the model was most sensitive.

If used instead of sputum microscopy, serology generated an estimated 14,000 more TB diagnoses, but also 121,000 more false-positive diagnoses, 102,000 fewer DALYs averted, and 32,000 more secondary TB cases than microscopy, at approximately four times the incremental cost (US$47.5 million versus US$11.9 million). When added to high-quality sputum smears, MGIT culture was estimated to avert 130,000 incremental DALYs at an incremental cost of US$213 per DALY averted. Serology was dominated by (i.e., more costly and less effective than) MGIT culture and remained less economically favorable than sputum smear or TB culture in one-way and multiway sensitivity analyses.

Conclusions:
In India, sputum smear microscopy remains the most cost-effective diagnostic test available for active TB; efforts to increase access to quality-assured microscopy should take priority. In areas where high-quality microscopy exists and resources are sufficient, MGIT culture is more cost-effective than serology as an additional diagnostic test for TB. These data informed a recently published World Health Organization policy statement against serological tests.

: Please see later in the article for the Editors' Summary

Vyšlo v časopise: Serological Testing Versus Other Strategies for Diagnosis of Active Tuberculosis in India: A Cost-Effectiveness Analysis. PLoS Med 8(8): e32767. doi:10.1371/journal.pmed.1001074
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001074

Souhrn

Zdroje

1. SmallPMPaiM 2010 Tuberculosis diagnosis--time for a game change. N Engl J Med 363 1070 1071

2. PerkinsMDCunninghamJ 2007 Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis 196 Suppl 1 S15 S27

3. KeelerEPerkinsMDSmallPHansonCReedS 2006 Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature 444 Suppl 1 49 57

4. CorbettELWattCJWalkerNMaherDWilliamsBG 2003 The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med 163 1009 1021

5. GilpinCKimSJLumbRRiederHL Van Deun A; Working Group on Sputum Smear Microscopy 2007 Critical appraisal of current recommendations and practices for tuberculosis sputum smear microscopy. Int J Tuberc Lung Dis 11 946 952

6. SteingartKRNgVHenryMHopewellPCRamsayA 2006 Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: A systematic review. Lancet Infect Dis 6 664 674

7. PaiMRamsayAO’BrienR 2008 Evidence-based tuberculosis diagnosis. PLoS Med 5 e156 doi:10.1371/journal.pmed.0050156

8. PaiMMinionJSohnHZwerlingAPerkinsMD 2009 Novel and improved technologies for tuberculosis diagnosis: progress and challenges. Clin Chest Med 30 701 716

9. World Health Organization 2010 Framework for implementing new tuberculosis diagnostics. Available: http://www.who.int/tb/laboratory/whopolicyframework_july10_revnov10.pdf. Accessed 13 March 2011

10. BoehmeCCNabetaPHillemannDNicolMPShenaiS 2010 Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med 363 1005 1015

11. World Health Organization 2010 Available: http://whqlibdoc.who.int/publications/2011/9789241501545_eng.pdf. Accessed 13 July 2011

12. GetahunHHarringtonMO’BrienRNunnP 2007 Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet 369 2042 2049

13. PerkinsMDRoscignoGZumlaA 2006 Progress towards improved tuberculosis diagnostics for developing countries. Lancet 367 942 943

14. SteingartKRFloresLLDendukuriNSchillerILaalS 2011 Commercial serological tests for the diagnosis of tuberculosis: an updated systematic review and meta-analysis. PLoS Med 8 e1062 doi:10.1371/journal.pmed.1001062

15. GrenierJPintoLNairDSteingartKRDowdyD 2011 Widespread use of serological tests for tuberculosis: data from 22 high-burden countries. Eur Respir J. In press

16. World Health Organization 2010 Expert group meeting report on commercial serodiagnostic tests for diagnosis of tuberculosis. Geneva WHO

17. DowdyDWO’BrienMABishaiD 2008 Cost-effectiveness of novel diagnostic tools for the diagnosis of tuberculosis. Int J Tuberc Lung Dis 12 1021 1029

18. Joint United Nations Programme on HIV/AIDS (UNAIDS) 2009 AIDS epidemic update 2009. Geneva: UNAIDS/WHO. Report UNAIDS/09.36E/ JC1700E

19. Special Programme for Research and Training in Tropical Diseases 2008 Diagnostics for tuberculosis: global demand and market potential. Geneva WHO 203 p

20. DowdyDWLourencoMCCavalcanteSCSaraceniVKingB 2008 Impact and cost-effectiveness of culture for diagnosis of tuberculosis in HIV-infected Brazilian adults. PLos ONE 3 e4057 doi:10.1371/journal.pone.0004057

21. MuellerDHMwengeLMuyoyetaMMuvwimiMWTembweR 2008 Costs and cost-effectiveness of tuberculosis cultures using solid and liquid media in a developing country. Int J Tuberc Lung Dis 12 1196 1202

22. SteingartKRHenryMLaalSHopewellPCRamsayA 2007 Commercial serological antibody detection tests for the diagnosis of pulmonary tuberculosis: a systematic review. PLoS Med 4 e202 doi:10.1371/journal.pmed.0040202

23. CrucianiMScarparoCMalenaMBoscoOSerpelloniG 2004 Meta-analysis of BACTEC MGIT 960 and BACTEC 460 TB, with or without solid media, for detection of mycobacteria. J Clin Microbiol 42 2321 2325

24. StybloK 1991 Epidemiology of tuberculosis. The Hague, The Netherlands Royal Netherlands Tuberculosis Association (KNCV) 136 p

25. United States Bureau of Labor Statistics 2010 Consumer price index: all urban consumers. Washington (D.C.): Bureau of Labor Statistics. Available: http://data.bls.gov/cgi-bin/surveymost?cu. Accessed 23 October 2010

26. World Health Organization 2009 Global tuberculosis control – epidemiology, strategy, financing. Report WHO/HTM/TB/2009.411. Geneva WHO 78 p

27. PantojaAFloydKUnnikrishnanKPJitendraRPadmaMR 2009 Economic evaluation of public-private mix for tuberculosis care and control, India. Part I. Socio-economic profile and costs among tuberculosis patients. Int J Tuberc Lung Dis 13 698 704

28. GoodchildMSahuSWaresFDewanPShuklaRS 2011 A cost-benefit analysis of scaling up tuberculosis control in India. Int J Tuberc Lung Dis 15 358 362

29. Central Intelligence Agency 2009 The world factbook. Washington (D.C.) Central Intelligence Agency Available:https://www.cia.gov/library/publications/the-world-factbook. Accessed 23 October 2010

30. Commission on Macroeconomics and Health 2001 Macroeconomics and health: investing in health for economic development. Geneva WHO 200 p

31. DowdyDWCattamanchiASteingartKRPaiM 2011 Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLoS Med 8 e1001063 doi:10.1371/journal.pmed.1001063

32. World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2008 Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis. Geneva World Health Organization 70 p

33. World Bank 1993 World development report 1993: investing in health. Oxford Oxford University Press 329 p

34. DowdyDWChaissonREMoultonLHDormanSE 2006 The potential impact of enhanced diagnostic techniques for tuberculosis driven by HIV: a mathematical model. AIDS 20 751 762

35. MorrisK 2011 WHO recommends against inaccurate tuberculosis tests. Lancet 377 113 114

36. Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) 2010 Report of the tenth meeting. Available: http://www.who.int/tb/advisory_bodies/stag_tb_report_2010.pdf. Accessed 13 March 2011

37. BehrMAWarrenSASalamonHHopewellPCPonce de LeonA 1999 Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet 353 444 449

38. PronykRMMakhubeleMBHargreavesJRTollmanSMHauslerHP 2001 Assessing health seeking behaviour among tuberculosis patients in rural South Africa. Int J Tuberc Lung Dis 5 619 627

39. SalaniponiFMHarriesADBandaHTKang'ombeCMphasaN 2000 Care-seeking behaviour and diagnostic processes in patients with smear-positive pulmonary tuberculosis in Malawi. Int J Tuberc Lung Dis 4 327 332

40. SquireSBBelayeAKKashotiASalaniponiFMMundyCJ 2005 ‘Lost’ smear-positive pulmonary tuberculosis cases: where are they and why did we lose them? Int J Tuberc Lung Dis 9 25 31

41. CreekTLLockmanSKenyonTAMakhoaMChimidzaN 2000 Completeness and timeliness of treatment initiation after laboratory diagnosis of tuberculosis in Gaborone, Botswana. Int J Tuberc Lung Dis 4 956 961

42. MurrayCLLopezAD 1996 The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Boston, Massachusetts Harvard School of Public Health 1022

43. Ministry of Health and Family Welfare 2010 TB India 2010: RNTCP Status Report. New Delhi: Central TB Division, Directorate General of Health Services (India). Available: http://www.tbcindia.org/pdfs/TB%20India%202010.pdf. Accessed 23 October 2010

44. Institute of Actuaries of India. Published Mortality Tables. Available: http://www.actuariesindia.org/Publication%20and%20Library%20Facility/mortality%20tables.htm. Accessed 23 October 2010

45. World Health Organization http://www.who.int/tb/laboratory/policy_statement/en. Accessed: 12 July 2011