Abstract
A rapid membrane-based serologic assay using the 38-kDa antigen from Mycobacterium tuberculosis for the diagnosis of tuberculosis (TB) was evaluated with 201 patients with pulmonary TB, 67 patients with extrapulmonary TB, 79 Mycobacterium bovis BCG-vaccinated healthy controls, and 77 non-TB respiratory patients. The overall sensitivities, specificities, and positive and negative predictive values were, respectively, 92, 92, 84, and 96% for sputum-positive TB patients; 70, 92, 87, and 79% for sputum-negative TB patients; and 76, 92, 80, and 90% for extrapulmonary-TB patients. Only 2% (1 of 44) of the healthy control BCG-vaccinated subjects gave weak positive signals in the assay, indicating that this rapid serological assay is a valuable aid in clinical diagnosis for both pulmonary and extrapulmonary TB.
Full Text
The Full Text of this article is available as a PDF (258.9 KB).
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Andersen A. B., Hansen E. B. Structure and mapping of antigenic domains of protein antigen b, a 38,000-molecular-weight protein of Mycobacterium tuberculosis. Infect Immun. 1989 Aug;57(8):2481–2488. doi: 10.1128/iai.57.8.2481-2488.1989. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Andersen P., Heron I. Specificity of a protective memory immune response against Mycobacterium tuberculosis. Infect Immun. 1993 Mar;61(3):844–851. doi: 10.1128/iai.61.3.844-851.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Ashbridge K. R., Bäckström B. T., Liu H. X., Vikerfors T., Englebretsen D. R., Harding D. R., Watson J. D. Mapping of T helper cell epitopes by using peptides spanning the 19-kDa protein of Mycobacterium tuberculosis. Evidence for unique and shared epitopes in the stimulation of antibody and delayed-type hypersensitivity responses. J Immunol. 1992 Apr 1;148(7):2248–2255. [PubMed] [Google Scholar]
- Baird P. N., Hall L. M., Coates A. R. Cloning and sequence analysis of the 10 kDa antigen gene of Mycobacterium tuberculosis. J Gen Microbiol. 1989 Apr;135(4):931–939. doi: 10.1099/00221287-135-4-931. [DOI] [PubMed] [Google Scholar]
- Bodmer T., Gurtner A., Schopfer K., Matter L. Screening of respiratory tract specimens for the presence of Mycobacterium tuberculosis by using the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test. J Clin Microbiol. 1994 Jun;32(6):1483–1487. doi: 10.1128/jcm.32.6.1483-1487.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Boesen H., Jensen B. N., Wilcke T., Andersen P. Human T-cell responses to secreted antigen fractions of Mycobacterium tuberculosis. Infect Immun. 1995 Apr;63(4):1491–1497. doi: 10.1128/iai.63.4.1491-1497.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bothamley G. H., Rudd R. M. Clinical evaluation of a serological assay using a monoclonal antibody (TB72) to the 38 kDa antigen of Mycobacterium tuberculosis. Eur Respir J. 1994 Feb;7(2):240–246. doi: 10.1183/09031936.94.07020240. [DOI] [PubMed] [Google Scholar]
- Bothamley G. H., Rudd R., Festenstein F., Ivanyi J. Clinical value of the measurement of Mycobacterium tuberculosis specific antibody in pulmonary tuberculosis. Thorax. 1992 Apr;47(4):270–275. doi: 10.1136/thx.47.4.270. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Chang Z., Choudhary A., Lathigra R., Quiocho F. A. The immunodominant 38-kDa lipoprotein antigen of Mycobacterium tuberculosis is a phosphate-binding protein. J Biol Chem. 1994 Jan 21;269(3):1956–1958. [PubMed] [Google Scholar]
- Collins F. M. Mycobacterial disease, immunosuppression, and acquired immunodeficiency syndrome. Clin Microbiol Rev. 1989 Oct;2(4):360–377. doi: 10.1128/cmr.2.4.360. [DOI] [PMC free article] [PubMed] [Google Scholar]
- D'Amato R. F., Wallman A. A., Hochstein L. H., Colaninno P. M., Scardamaglia M., Ardila E., Ghouri M., Kim K., Patel R. C., Miller A. Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test. J Clin Microbiol. 1995 Jul;33(7):1832–1834. doi: 10.1128/jcm.33.7.1832-1834.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Deshpande R. G., Khan M. B., Bhat D. A., Navalkar R. G. Purification and partial characterisation of a novel 66-kDa seroreactive protein of Mycobacterium tuberculosis H37Rv. J Med Microbiol. 1994 Sep;41(3):173–178. doi: 10.1099/00222615-41-3-173. [DOI] [PubMed] [Google Scholar]
- Espitia C., Cervera I., González R., Mancilla R. A 38-kD Mycobacterium tuberculosis antigen associated with infection. Its isolation and serologic evaluation. Clin Exp Immunol. 1989 Sep;77(3):373–377. [PMC free article] [PubMed] [Google Scholar]
- Espitia C., Mancilla R. Identification, isolation and partial characterization of Mycobacterium tuberculosis glycoprotein antigens. Clin Exp Immunol. 1989 Sep;77(3):378–383. [PMC free article] [PubMed] [Google Scholar]
- Hasløv K., Andersen A. B., Ljungqvist L., Weis Bentzon M. Comparison of the immunological activity of five defined antigens from Mycobacterium tuberculosis in seven inbred guinea pig strains. The 38-kDa antigen is immunodominant. Scand J Immunol. 1990 Apr;31(4):503–514. doi: 10.1111/j.1365-3083.1990.tb02798.x. [DOI] [PubMed] [Google Scholar]
- Havlir D. V., Wallis R. S., Boom W. H., Daniel T. M., Chervenak K., Ellner J. J. Human immune response to Mycobacterium tuberculosis antigens. Infect Immun. 1991 Feb;59(2):665–670. doi: 10.1128/iai.59.2.665-670.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Ivanyi J., Krambovitis E., Keen M. Evaluation of a monoclonal antibody (TB72) based serological test for tuberculosis. Clin Exp Immunol. 1983 Nov;54(2):337–345. [PMC free article] [PubMed] [Google Scholar]
- Jackett P. S., Bothamley G. H., Batra H. V., Mistry A., Young D. B., Ivanyi J. Specificity of antibodies to immunodominant mycobacterial antigens in pulmonary tuberculosis. J Clin Microbiol. 1988 Nov;26(11):2313–2318. doi: 10.1128/jcm.26.11.2313-2318.1988. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kox L. F., Rhienthong D., Miranda A. M., Udomsantisuk N., Ellis K., van Leeuwen J., van Heusden S., Kuijper S., Kolk A. H. A more reliable PCR for detection of Mycobacterium tuberculosis in clinical samples. J Clin Microbiol. 1994 Mar;32(3):672–678. doi: 10.1128/jcm.32.3.672-678.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Noordhoek G. T., Kolk A. H., Bjune G., Catty D., Dale J. W., Fine P. E., Godfrey-Faussett P., Cho S. N., Shinnick T., Svenson S. B. Sensitivity and specificity of PCR for detection of Mycobacterium tuberculosis: a blind comparison study among seven laboratories. J Clin Microbiol. 1994 Feb;32(2):277–284. doi: 10.1128/jcm.32.2.277-284.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Singh M., Andersen A. B., McCarthy J. E., Rohde M., Schütte H., Sanders E., Timmis K. N. The Mycobacterium tuberculosis 38-kDa antigen: overproduction in Escherichia coli, purification and characterization. Gene. 1992 Aug 1;117(1):53–60. doi: 10.1016/0378-1119(92)90489-c. [DOI] [PubMed] [Google Scholar]
- Sørensen A. L., Nagai S., Houen G., Andersen P., Andersen A. B. Purification and characterization of a low-molecular-mass T-cell antigen secreted by Mycobacterium tuberculosis. Infect Immun. 1995 May;63(5):1710–1717. doi: 10.1128/iai.63.5.1710-1717.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Thierry D., Brisson-Noël A., Vincent-Lévy-Frébault V., Nguyen S., Guesdon J. L., Gicquel B. Characterization of a Mycobacterium tuberculosis insertion sequence, IS6110, and its application in diagnosis. J Clin Microbiol. 1990 Dec;28(12):2668–2673. doi: 10.1128/jcm.28.12.2668-2673.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Thierry D., Cave M. D., Eisenach K. D., Crawford J. T., Bates J. H., Gicquel B., Guesdon J. L. IS6110, an IS-like element of Mycobacterium tuberculosis complex. Nucleic Acids Res. 1990 Jan 11;18(1):188–188. doi: 10.1093/nar/18.1.188. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Verbon A., Hartskeerl R. A., Moreno C., Kolk A. H. Characterization of B cell epitopes on the 16K antigen of Mycobacterium tuberculosis. Clin Exp Immunol. 1992 Sep;89(3):395–401. doi: 10.1111/j.1365-2249.1992.tb06969.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Verbon A., Kuijper S., Jansen H. M., Speelman P., Kolk A. H. Antigens in culture supernatant of Mycobacterium tuberculosis: epitopes defined by monoclonal and human antibodies. J Gen Microbiol. 1990 May;136(5):955–964. doi: 10.1099/00221287-136-5-955. [DOI] [PubMed] [Google Scholar]
- Verbon A., Weverling G. J., Kuijper S., Speelman P., Jansen H. M., Kolk A. H. Evaluation of different tests for the serodiagnosis of tuberculosis and the use of likelihood ratios in serology. Am Rev Respir Dis. 1993 Aug;148(2):378–384. doi: 10.1164/ajrccm/148.2.378. [DOI] [PubMed] [Google Scholar]
- Vordermeier H. M., Harris D. P., Friscia G., Román E., Surcel H. M., Moreno C., Pasvol G., Ivanyi J. T cell repertoire in tuberculosis: selective anergy to an immunodominant epitope of the 38-kDa antigen in patients with active disease. Eur J Immunol. 1992 Oct;22(10):2631–2637. doi: 10.1002/eji.1830221024. [DOI] [PubMed] [Google Scholar]
- Vuorinen P., Miettinen A., Vuento R., Hällström O. Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test. J Clin Microbiol. 1995 Jul;33(7):1856–1859. doi: 10.1128/jcm.33.7.1856-1859.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Wilkins E. G., Ivanyi J. Potential value of serology for diagnosis of extrapulmonary tuberculosis. Lancet. 1990 Sep 15;336(8716):641–644. doi: 10.1016/0140-6736(90)92144-7. [DOI] [PubMed] [Google Scholar]
- Young D., Kent L., Rees A., Lamb J., Ivanyi J. Immunological activity of a 38-kilodalton protein purified from Mycobacterium tuberculosis. Infect Immun. 1986 Oct;54(1):177–183. doi: 10.1128/iai.54.1.177-183.1986. [DOI] [PMC free article] [PubMed] [Google Scholar]