Serological tests for the diagnosis of active tuberculosis: Relevance for India

Indian Journal of Medical Research

Volumn 135, Issue 5, 2012, Pages 695-702

  Steingart, Karen R ^a   Ramsay, Andrew ^b   Dowdy, David W ^c   Pai, Madhukar ^d,e  

^a UNIVERSITY OF WASHINGTON   (United States)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

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

^d MCGILL UNIVERSITY   (Canada)

^e MCGILL UNIVERSITY   (Canada)

Author keywords

Antibody; Diagnosis; Sensitivity and specificity; Serology; Tuberculosis

Indexed keywords

ANTIBODY;

DIAGNOSTIC ERROR; ENZYME LINKED IMMUNOSORBENT ASSAY; EXTRAPULMONARY TUBERCULOSIS; HISTOPATHOLOGY; HUMAN; INDIA; INFECTION; LUNG TUBERCULOSIS; MICROSCOPY; PATIENT SAFETY; POINT OF CARE TESTING; REVIEW; SENSITIVITY AND SPECIFICITY; SEROLOGY; SPUTUM ANALYSIS; SYSTEMATIC REVIEW (TOPIC); TUBERCULOSIS; WORLD HEALTH ORGANIZATION;

EID: 84863313177     PISSN: 09715916     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (34)

1. Steingart KR, Ng V, Henry M, Hopewell PC, Ramsay A, Cunningham J, et al. Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review. Lancet Infect Dis 2006; 6: 664-74.
2. Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis 2007; 196 (Suppl 1): S15-27.
3. nded. Geneva: World Health Organization; 2004. p. 80-3.
4. 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: 1005-15.
5. nded. The Hague: Tuberculosis Coalition for Technical Assistance; 2009.
6. World Health Organization Special Programme for Research and Training in Tropical Diseases, Foundation for Innovative New Diagnostics. Diagnostics for tuberculosis: global demand and market potential. Geneva: World Health Organization; 2006. p. 49-72. Available from: http://www.who.int/tdr/ publications/en/, accessed on March 23, 2012.
7. Grenier J, Pinto L, Nair D, Steingart K, Dowdy D, Ramsay A, et al. Widespread use of serological tests for tuberculosis: data from 22 high-burden countries. Eur Respir J 2012; 39: 502-5.
8. Specter M. A deadly misdiagnosis. The New Yorker. New York; 2010. p. 48-53. Available from: http://www.newyorker. com/reporting/2010/11/15/101115fa_fact_specter, accessed on March 23, 2012.
9. Chinnock P. The scandal of TB misdiagnosis. Tropical diseases research to foster innovation & knowledge application; 2010. Available from: http://www.tropika.net/svc/news/20101113/ Chinnock-20101113-News-TB-India, accessed on: March 22, 2012.
10. Morris K. WHO recommends against inaccurate tuberculosis tests. Lancet 2011; 377: 113-4.
11. Leeflang MM, Deeks JJ, Gatsonis C, Bossuyt PM; Cochrane Diagnostic Test Accuracy Working Group. Systematic reviews of diagnostic test accuracy. Ann Intern Med 2008; 149: 889-97.
12. Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Analysing and presenting results. In: Deeks JJ, Bossuyt PM, Gatsonis C, editors. Cochrane handbook for systematic reviews of diagnostic test accuracy, version 1.0. London: The Cochrane Collaboration; 2010. Available from: http://srdta. cochrane.org/, accessed on March 22, 2012.
13. Dowdy DW, Steingart KR, Pai M. Serological testing versus other strategies for diagnosis of active tuberculosis in India: a cost-effectiveness analysis. PLoS Med 2011; 8: e1001074.
14. Jarosławski S, Pai M. Why are inaccurate tuberculosis serological tests widely used in the Indian private healthcare sector? A root-cause analysis. J Epi Global Health 2012; 2: 39-50.
15. Dinnes J, Deeks J, Kunst H, Gibson A, Cummins E, Waugh N, et al. A systematic review of rapid diagnostic tests for the detection of tuberculosis infection. Health Technol Assess 2007; 11: 1-196.
16. Steingart KR, Henry M, Laal S, Hopewell PC, Ramsay A, Menzies D, et al. Commercial serological antibody detection tests for the diagnosis of pulmonary tuberculosis: a systematic review. PLoS Med 2007; 4: e202.
17. Steingart KR, Henry M, Laal S, Hopewell PC, Ramsay A, Menzies D, et al. A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis. Thorax 2007; 62: 911-8.
18. Steingart KR, Dendukuri N, Henry M, Schiller I, Nahid P, Hopewell PC, et al. Performance of purified antigens for serodiagnosis of pulmonary tuberculosis: a meta-analysis. Clin Vaccine Immunol 2009; 16: 260-76.
19. World Health Organization on behalf of the Special Programme for Research & Training in Tropical Diseases. Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis; 2008. Geneva: World Health Organization. Available from: http://www.who.int/tdr/ publications/documents/diagnostic-evaluation-2.pdf, accessed on March 21, 2012.
20. Steingart KR, Flores LL, Dendukuri N, Schiller I, Laal S, Ramsay A, et al. Commercial serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: an updated systematic review and meta-analysis. PLoS Med 2011; 8: e1001062.
21. Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003; 3: 25.
22. Rutter CM, Gatsonis CA. A hierarchical regression approach to meta-analysis of diagnostic test accuracy evaluations. Stat Med 2001; 20: 2865-84.
23. Kassa-Kelembho E, Kassa E, Zandanga G, Service YB, Ignaleamoko A, Talarmin A. Poor performance of a novel serological test for diagnosis of pulmonary tuberculosis in Bangui, Central African Republic. Clin Vaccine Immunol 2006; 13: 702-3.
24. Ratanasuwan W, Kreiss JK, Nolan CM, Schaeffler BA, Suwanagool S, Tunsupasawasdikul S, et al. Evaluation of the MycoDot test for the diagnosis of tuberculosis in HIV seropositive and seronegative patients. Int J Tuberc Lung Dis 1997; 1: 259-64.
25. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336: 924-6.
26. Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011; 64: 401-6.
27. Pai M, Minion J, Steingart K, Ramsay A. New and improved tuberculosis diagnostics: evidence, policy, practice, and impact. Curr Opin Pulm Med 2010; 16: 271-84.
28. Schunemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008; 336: 1106-10.
29. World Health Organization. Commercial serodiagnostic tests for diagnosis of tuberculosis. Policy Statement: 2011. Geneva: World Health Organization. WHO/HTM/TB/2011.5. Available from: http://www.tbevidence.org/documents/policies/WHO% 20Policy%20Statement%20on%20Commercial%20TB%20 Serodiagnostic%20Tests%202011.pdf, accessed on June 18, 2012.
30. Kumar A. Directorate General of Health Services. Advisory against commercial serological tests. Central TB Division, Ministry of Health and Family Welfare. New Delhi; 2011. Available from: http://www.tbcindia.nic.in/pdfs/Letter_ Serodiagnosis.pdf, accessed on March 22, 2012.
31. Ghosh A. Health Ministry set to ban commonly used TB test. Indian Express, 20 March 2012. Available from: http://www. indianexpress.com/news/health-ministry-set-to-ban-commonlyused-tb-test/925754/, accessed on June 16, 2012.
32. Singh S, Katcoh VM. Commercial serological tests for the diagnosis of active tuberculosis in India: time for introspection. Indian J Med Res 2011; 134: 583-87.
33. World Health Organization. Global tuberculosis control: WHO report 2011. Geneva: World Health Organization. Available from: http://www.who.int/tb/publications/global_report/2011/ gtbr11_full.pdf, accessed on March 21, 2012.
34. Working Group on Tuberculosis. Indian Academy of Pediatrics. Consensus statement on childhood tuberculosis. Indian Pediatr 2010; 47: 41-55.