PDF herunterladen
CC BY-NC-ND 4.0 · J Lab Physicians 2013; 5(01): 11-16
DOI: 10.4103/0974-2727.115902
Original Article

Diagnostic Performance of Commercially Available Enzyme-Linked Immunosorbent Assay Kit in the Diagnosis of Extrapulmonary Tuberculosis

Manimuthu Mani Sankar
Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India
,
Veena Balooni
Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India
,
Jitendra Singh
Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India
,
Sarman Singh
Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India
› Institutsangaben Source of Support: Indian Council of Medical Research, New Delhi (ICMR Sanction Order Number: 5/8/5/4/2005-ECD-I). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
› Weitere Informationen
Auch verfügbar auf
  als PDF herunterladen Lizenzen und Reprints

ABSTRACT

Objectives: Antibody based serodiagnosis tests for tuberculosis (TB) was used widely in developed and developing countries. Pathozyme Myco® immunoglobulin (Ig) M, IgA, and IgG were evaluated in pulmonary TB in many studies.

Materials and Methods: In this study we assessed this commercially available kit in detecting extrapulmonary TB (EPTB).

Results: A total of 354 subjects were recruited for the study, of which 217 (61.2%) were EPTB patients and 137 (38.7%) were subjects with no suggestive TB. The mean age was 29.7 ± 13.7 and 31.2 ± 15.2 years, respectively for two groups. Serum samples were tested for IgM, IgA, and IgG using Pathozyme Myco® IgM, IgA, and IgG kit. The individual specificity rates of IgM, IgA, and IgG were 70.8% (95% confidence interval (CI): 62.7-77.7), 77.3% (95% CI: 68.6-83.5), and 68.6%. (95% CI: 60.4-75.7); while their sensitivity was 29% (95% CI: 23.4-35.4), 24.4% (95% CI: 19.1-30.5), and 34.5% (95% CI: 28.5-41.1); respectively.

Conclusion: The serological tests either singly or in combination failed or performed poorly to diagnose EPTB.

Key words:

Diagnosis - extrapulmonary tuberculosis - serology


Publikationsverlauf

Artikel online veröffentlicht:
07. April 2020

© 2013.

Thieme Medical and Scientific Publishers Private Ltd.
A-12, Second Floor, Sector -2, NOIDA -201301, India

 

  • REFERENCES

  • 1 Singh S, Sankar MM, Gopinath K. High rate of extensively drug-resistant tuberculosis in Indian AIDS patients. AIDS 2007;21:2345-7.
  • 2 World Health Organization. Global tuberculosis control. Report WHO, Geneva. Available from: http://apps.who.int/iris/bitstream/10665/75938/1/9789241564502_eng.pdf [Last accessed date on 2013 June 28].
  • 3 Steingart K, Flores LL, Dendukuri N, Schiller I, Laal S, Ramsay A, et al. Commercial serological tests for diagnosis of active pulmonary and extrapulmonary tuberculosis: An updated systematic review and meta-analysis. PLoS Med 2011;8:e1001062.
  • 4 Banerjee S, Gupta S, Shende N, Kumar S, Harinath BC. Serodiagnosis of tuberculosis using two ELISA systems. Indian J Clin Biochem 2003;18:48-53.
  • 5 World Health Organization. Commercial serodiagnostic tests for diagnosis of tuberculosis: Policy statement. WHO: Geneva. Available from: http://whqlibdoc.who.int/publications/2011/9792415052054_eng.pdf. 2011 [Last accessed date on 2013 June 28].
  • 6 Singh S, Katoch VM. Commercial serological tests for the diagnosis of active tuberculosis in India: Time for introspection. Indian J Med Res 2011;134:583-7.
  • 7 Singh S, Singh J, Kumar S, Gopinath K, Balooni V, Singh N, et al. Poor performance of serological tests in the diagnosis of pulmonary tuberculosis: Evidence from a contact tracing field study. PLoS ONE 2012;7:e40213.
  • 8 Sankar MM, Singh J, Diana SC, Singh S. 2012. Molecular characterization of Mycobacterium tuberculosis isolates from North Indian patients with extrapulmonary tuberculosis. Tuberculosis (Edinb) 2013;93:75-83.
  • 9 Sankar MM, Kumar P, Munawwar A, Kumar M, Singh J, Singh A, et al. Usefulness of multiplex PCR in the diagnosis of genital tuberculosis in females with infertility. Eur J Clin Microbiol Infect Dis 2012;32:399-405.
  • 10 Singh M, Andrson AB, McCarthy JE, Rohde M, Scutte H, Sanders E, et al. The mycobacterium tuberculosis 38-kDa antigen: Overproduction in Escherichia coli, purification and characterization. Gene 1992;117:53-60.
  • 11 Wares F, Balasubramanian R, Mohan A, Sharma SK. Extrapulmonary tuberculosis: Management and control. In: Agarwal SP, Chauhan LS, editors. Tuberculosis control in India. New Delhi: Ministry of Health and Family Welfare; 2005. p. 95-114.
  • 12 Ivanyi J, Sharp K, Jackett P, Bothamley G. Immunological study of the defined constituents of mycobacteria. Springer Semin Immunopathol 1988;10:279-300.
  • 13 Ivanyi J, Krambovitis E, Keen M. Evaluation of a monoclonal antibody (TB72) based serological test for tuberculosis. Clin Exp Immunol 1983;54:337-45.
  • 14 Abebe F, Holm-Hansen C, Wiker HG, Bjune G. Progress in serodiagnosis of Mycobacterium tuberculosis infection. Scand J Immunol 2007;66:176-91.
  • 15 Ratanasuwan W, Kreiss JK, Nolan CM, Schaeffler BA, Suwanagool S, Tunsupasawasdikul S, et al. Evaluation of the Myco Dot test for the diagnosis of tuberculosis in HIV seropositive and seronegative patients. Int J Tuberc Lung Dis 1997;1:259-64.
  • 16 Pottumarthy S, Wells VC, Morris AJ. A comparison of seven tests for serological diagnosis of tuberculosis. J Clin Microbiol 2000;38:2227-31.
  • 17 Chierakul N, Damrongchokpipat P, Chaiprasert A, Arjratanakul W. Antibody detection for the diagnosis of tuberculous pleuritis. Int J Tuberc Lung Dis 2001;5:968-72.
  • 18 Senol G, Erer OF, Yalcin YA, Coskun M. Gündüz AT, Biçmen C, et al. Humoral immune response against 38-kDa and 16-kDa mycobacterial antigens in tuberculosis. Eur Respir J 2007;29:143-8.
  • 19 Lyashchenko K, Colangeli R, Houde M, Al Jahdali H, Menzies D, Gennaro ML. Heterogenous antibody responses in tuberculosis. Infect Immun 1998;66:3936-40.
  • 20 Weildingh K, Rosenkrands I, Okkeles LM, Doherty TM, Andersen P. Assessing the serodiagnostic potential of 35 Mycobacterium tuberculosis proteins and identification of four novel serological antigens. J Clini Microbiol 2005;43:57-65.