A systematic review of commercial serological antibody detection tests for the diagnosis of extrapulmonary tuberculosis

Thorax

Volumn 62, Issue 10, 2007, Pages 911-918

  Steingart, Karen R ^b   Henry, Megan ^c   Laal, Suman ^d   Hopewell, Philip C ^b   Ramsay, Andrew ^e   Menzies, Dick ^f   Cunningham, Jane ^e   Weldingh, Karin ^g   Pai, Madhukar ^a,f  

^a MCGILL UNIVERSITY   (Canada)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Adult Correctional Health Services   (United States)

^d NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e WORLD HEALTH ORGANIZATION   (Switzerland)

^f MCGILL UNIVERSITY   (Canada)

^g STATENS SERUM INSTITUT   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G;

ANTIBODY DETECTION; CLINICAL ARTICLE; DATA BASE; DIAGNOSTIC ACCURACY; EXTRAPULMONARY TUBERCULOSIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; PRIORITY JOURNAL; REVIEW; SERODIAGNOSIS;

ANTIGENS, BACTERIAL; AREA UNDER CURVE; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOGLOBULINS; SENSITIVITY AND SPECIFICITY; SEROLOGIC TESTS; TUBERCULOSIS;

EID: 34347225013     PISSN: 00406376     EISSN: None     Source Type: Journal    
DOI: 10.1136/thx.2006.075754     Document Type: Review

References (70)

1. Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2005. Atlanta: US Department of Health and Human Services, CDC, 2006:64.
2. World Health Organization. TB epidemiology and surveillance workshop, 2006, http://www.who.int/tb/surveillanceworkshop/trend_analysis/ increasing_decreasing_over_under_diagnosis_of_extrapulmonary_tb.htm (accessed 6 October 2006).
3. Iseman MD. Tuberculosis in relation to HIV and AIDS. In: Iseman MD, ed. A clinician's guide to tuberculosis. Philadelphia: Lippincott Williams and Wilkins, 2000:207-9.
4. Hopewell PC. Tuberculosis and other mycobacterial diseases. In: Mason RJ, Broaddus VC, Murray JF, Nadel JA, eds. Murray and Nadel's textbook of respiratory medicine, 4th edn. Philadelphia: Saunders, 2005:984-1026.
5. Talavera W, Lessnau K-D KL, Handwerger S. Extrapulmonary tuberculosis. In: Friedman LN, eds. Tuberculosis, 1st edn. Boca Raton: CRC Press, 1994:113-51.
6. Shingadia D, Novelli V. Diagnosis and treatment of tuberculosis in children. Lancet Infect Dis 2003;3:624-32.
7. Hopewell PC, Pai M, Maher D, et al. International standards for tuberculosis care. Lancet Infect Dis 2006;6:710-25.
8. Perkins MD, Roscigno G, Zumla A. Progress towards improved tuberculosis diagnostics for developing countries. Lancet 2006;367:942-3.
9. Hargreaves NJ, Kadzakumanja O, Whitty CJ, et al. 'Smear-negative' pulmonary tuberculosis in a DOTS programme: poor outcomes in an area of high HIV seroprevalence. Int J Tuberc Lung Dis 2001;5:847-54.
10. Iseman MD. Extrapulmonary tuberculosis in adults. In: Iseman MD, ed. A clinician's guide to tuberculosis. Philadelphia: Lippincott Williams and Wilkins, 2000:145-97.
11. Shafer RW, Kim DS, Weiss JP, et al. Extrapulmonary tuberculosis in patients with human immunodeficiency virus infection. Medicine (Baltimore) 1991;70:384-97.
12. Golden MP, Vikram HR. Extrapulmonary tuberculosis: an overview. Am Fam Physician 2005;72:1761-8.
13. Richter C, Ndosi B, Mwammy AS, et al. Extrapulmonary tuberculosis-a simple diagnosis? A retrospective study at Dar es Salaam, Tanzania. Trop Geogr Med 1991;43:375-8.
14. d'Arminio Monforte A, Vago L, Gori A, et al. Clinical diagnosis of mycobacterial diseases versus autopsy findings in 350 patients with AIDS. Eur J Clin Microbiol Infect Dis 1996;15:453-8.
15. Rana FS, Hawken MP, Mwachari C, et al. Autopsy study of HIV-1-positive and HIV-1-negative adult medical patients in Nairobi, Kenya. J Acquir Immune Defic Syndr 2000;24:23-9.
16. Weir MR, Thornton GF. Extrapulmonary tuberculosis. Experience of a community hospital and review of the literature. Am J Med 1985;79:467-78.
17. Menzies D. What is the current and potential role of diagnostic tests other than sputum microscopy and culture? In: Frieden T, eds. Toman's tuberculosis: case detection, treatment, and monitoring - questions and answers, 2nd ed. Geneva: World Health Organization, 2004:88.
18. Bothamley GH. Serological diagnosis of tuberculosis. Eur Respir J Suppl 1995;20:676-88s.
19. Chan ED, Heifets L, Iseman MD. Immunologic diagnosis of tuberculosis: a review. Tuberc Lung Dis 2000;80:131-40.
20. Daniel TM. Rapid diagnosis of tuberculosis: laboratory techniques applicable in developing countries. Rev Infect Dis 1989;11(Suppl 2):S471-8.
21. Daniel TM. The rapid diagnosis of tuberculosis: a selective review. J Lab Clin Med 1990;116:277-82.
22. Gennaro ML. Immunologic diagnosis of tuberculosis. Clin Infect Dis 2000;30(Suppl 3):S243-6.
23. Iseman MD. Immunity and pathogenesis. In: Iseman MD, eds. A clinician's guide to tuberculosis. Philadelphia: Lippincott Williams and Wilkins, 2000:63-96.
24. Palomino JC. Nonconventional and new methods in the diagnosis of tuberculosis: feasibility and applicability in the field. Eur Respir J 2005;26:339-50.
25. Pai M, Kalantri S, Dheda K. New tools and emerging technologies for the diagnosis of tuberculosis: part II. Active tuberculosis and drug resistance. Expert Rev Mol Diagn 2006;6:423-32.
26. Laal S. Immunodiagnosis. In: Rom WN, Garay SM, eds. Tuberculosis. Philadelphia: Lippincott, Williams & Wilkins, 2004:185-91.
27. Laal S, Skeiky YA. Immune-based methods. In: Cole ST, eds. Tuberculosis and the tubercle bacillus. Washington, DC: ASM Press, 2005:71-83.
28. Boehme C, Molokova E, Minja F, et al. Detection of mycobacterial lipoarabinomannan with an antigen-capture ELISA in unprocessed urine of Tanzanian patients with suspected tuberculosis. Trans R Soc Trop Med Hyg 2005;99:893-900.
29. Tessema TA, Hamasur B, Bjun G, et al. Diagnostic evaluation of urinary lipoarabinomannan at an Ethiopian tuberculosis centre. Scand J Infect Dis 2001;33:279-84.
30. Small PM, Perkins MD. More rigour needed in trials of new diagnostic agents for tuberculosis. Lancet 2000;356:1048-9.
31. Walsh A, McNerney R. Guidelines for establishing trials of new tests to diagnose tuberculosis in endemic countries. Int J Tuberc Lung Dis 2004;8:609-13.
32. 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, 2006:61.
33. Pai M, McCulloch M, Enanoria W, et al. Systematic reviews of diagnostic test evaluations: what's behind the scenes? ACP J Club 2004;141:A11-3.
34. Whiting P, Rutjes AW, Reitsma JB, et al. 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.
35. Littenberg B, Moses LE. Estimating diagnostic accuracy from multiple conflicting reports: a new meta-analytic method. Med Decis Making 1993;13:313-21.
36. SPSS for Windows. 14.0.1.366 version. Chicago: SPSS Inc, 2006.
37. Zamora J, Abraira V, Muriel A, et al. Meta-DiSc: a software for meta-analysis of test accuracy data. BMC Med Res Methodol 2006;6:31.
38. Jones CM, Athanasiou T. Summary receiver operating characteristic curve analysis techniques in the evaluation of diagnostic tests. Ann Thorac Surg 2005;79:16-20.
39. Walter SD. Properties of the summary receiver operating characteristic (SROC) curve for diagnostic test data. Stat Med 2002;21:1237-56.
40. Lijmer JG, Bossuyt PM, Heisterkamp SH. Exploring sources of heterogeneity in systematic reviews of diagnostic tests. Stat Med 2002;21:1525-37.
41. Alifano M, De Pascalis R, Sofia M, et al. Detection of IgG and IgA against the mycobacterial antigen A60 in patients with extrapulmonary tuberculosis. Thorax 1998;53:377-80.
42. Banerjee S, Gupta S, Shende N, et al. Serodiagnosis of tuberculosis using two ELISA systems. Indian J Clin Biochem 2003;18:48-53.
43. Caminero JA, Rodriguez de Castro F, Carrillo T, et al. Diagnosis of pleural tuberculosis by detection of specific IgG anti-antigen 60 in serum and pleural fluid. Respiration 1993;60:58-62.
44. Caminero JA, Rodriguez de Castro F, Carrillo T, et al. Value of ELISA using A60 antigen in the serodiagnosis of tuberculosis. Respiration 1994;61:283-6.
45. Gevaudan MJ, Bollet C, Charpin D, et al. Serological response of tuberculosis patients to antigen 60 of BCG. Eur J Epidemiol 1992;8:666-76.
46. Kunter E, Cerrahoglu K, Ilvan A, et al. The value of pleural fluid anti-A60 IgM in BCG-vaccinated tuberculous pleurisy patients. Clin Microbiol Infect 2003;9:212-20.
47. Luh KT, Yu CJ, Yang PC, et al. Tuberculosis antigen A60 serodiagnosis in tuberculous infection: application in extrapulmonary and smear-negative pulmonary tuberculosis. Respirology 1996;1:145-51.
48. McConkey SJ, Youssef FG, Azem E, et al. Evaluation of a rapid-format antibody test and the tuberculin skin test for diagnosis of tuberculosis in two contrasting endemic settings. Int J Tuberc Lung Dis 2002;6:246-52.
49. Nsanze H, Ameen AS, Fares E, et al. Serodiagnosis of tuberculosis and leprosy by enzyme immunoassay. Clin Microbiol Infect 1997;3:236-9.
50. Houghton RL, Lodes MJ, Dillon DC, et al. Use of multiepitope polyproteins in serodiagnosis of active tuberculosis. Clin Diagn Lab Immunol 2002;9:883-91.
51. Weldingh K, Rosenkrands I, Okkels LM, et al. Assessing the serodiagnostic potential of 35 Mycobacterium tuberculosis proteins ana identification of four novel serological antigens. J Clin Microbiol 2005;43:57-65.
52. Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA 1999;282:1061-6.
53. Tatsioni A, Zarin DA, Aronson N, et al. Challenges in systematic reviews of diagnostic technologies. Ann Intern Med 2005;142:1048-55.
54. McMurray DN. Disease model: pulmonary tuberculosis. Trends MoI Med 2001;7:135-7.
55. Samanich K, Belisle JT, Laal S. Homogeneity of antibody responses in tuberculosis patients. Infect Immun 2001;69:4600-9.
56. Singh KK, Zhang X, Patibandla AS, et al. Antigens of Mycobacterium tuberculosis expressed during preclinical tuberculosis: serological immunodominance of proteins with repetitive amino acid sequences. Infect Immun 2001;69:4185-91.
57. Talaat AM, Lyons R, Howard ST, et al. The temporal expression profile of Mycobacterium tuberculosis infection in mice. Proc Natl Acad Sci USA 2004;101:4602-7.
58. Delogu G, Sanguinetti M, Pusceddu C, et al. PE_PGRS proteins are differentially expressed by Mycobacterium tuberculosis in host tissues. Microbes Infect 2006;8:2061-7.
59. Sartain MJ, Slayden RA, Singh KK, et al. Disease state differentiation and identification of tuberculosis biomarkers via native antigen array profiling. Mol Cell Proteomics 2006:2102-13.
60. Elliott AM, Namaambo K, Allen BW, et al. Negative sputum smear results in HIV-positive patients with pulmonary tuberculosis in Lusaka, Zambia. Tuberc Lung Dis 1993;74:191-4.
61. Johnson JL, Vjecha MJ, Okwera A, et al. Impact of human immunodeficiency virus type-1 infection on the initial bacteriologic and radiographic manifestations of pulmonary tuberculosis in Uganda. Makerere University-Case Western Reserve University Research Collaboration. Int J Tuberc Lung Dis 1998;2:397-404.
62. De Milito A, Nilsson A, Titanji K, et al. Mechanisms of hypergammaglobulinemia and impaired antigen-specific humoral immunity in HIV-1 infection. Blood 2004;103:2180-6.
63. Martinez-Maza O, Crabb E, Mitsuyasu RT, et al. Infection with the human immunodeficiency virus (HIV) is associated with an in vivo increase in B lymphocyte activation and immaturity. J Immunol 1987;138:3720-4.
64. Nagase H, Agematsu K, Kitano K, et al. Mechanism of hypergammaglobulinemia by HIV infection: circulating memory B-cell reduction with plasmacytosis. Clin Immunol 2001;100:250-9.
65. Laal S, Samanich KM, Sonnenberg MG, et al. Surrogate marker of preclinical tuberculosis in human immunodeficiency virus infection: antibodies to an 88-kDa secreted antigen of Mycobacterium tuberculosis. J Infect Dis 1997;176:133-43.
66. Hendrickson RC, Douglass JF, Reynolds LD, et al. Mass spectrometry identification of Mtb81, a novel serological marker for tuberculosis. J Clin Microbiol 2000;38:2354-61.
67. Singh KK, Dong Y, Belisle JT, et al. Antigens of Mycobacterium tuberculosis recognized by antibodies during incipient, subclinical tuberculosis. Clin Diagn Lab Immunol 2005;12:354-8.
68. Pai M, O'Brien R. Tuberculosis diagnostics trials: do they lack methodological rigor? Expert Rev Mol Diagn 2006;6:509-14.
69. Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Ann Intern Med 2003;138:40-4.
70. Banoo S, Bell D, Bossuyt P, et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2006;4:S21-31.