Article Sidebar

Download
Rapid test for HBSAG

Main Article Content

Abstract

Introduction: Hepatitis B Virus infection is a leading cause of liver disease worldwide. HBV is diagnosed by PCR, Enzyme immunoassay (EIA), RIA, and Rapid Tests such as Immuno agglutination and immunochromatography. Rapid tests are less costly, and easy to perform, hence can be used in areas with limited resources such as District and Peripheral hospitals for screening blood donors.

Objectives: The main objective of this study was to evaluate the Rapid diagnostic tests for the detection of HBsAg in Yaounde-Cameroon.

Methodology: A comparative cross sectional study was conducted for 4 months at Yaoundé Central Hospital, Centre hospitalier d’Essos-Yaounde, and Clinique de l’Espoir Essos, between May and September 2008. Using SD HBsAg ELISA (Standard diagnostics, Korea) as gold standard, the rapid tests are: Determine HBsAg (Abbott Japan), Acumen HBsAg (Nafdac), and Vikia HBsAg (Biomerieux, Brazil).The Relative Sensitivity, Relative Specificity, Positive Predictive Value (PPV), and Negative predictive Value (NPV) of rapid tests were determined. A random sample of 360 patients, including 180 regular blood donors and 180 patients with history of viral hepatitis B (Patients who came for consultation and blood donors who were diagnosed positive for HBsAg), who attended the above hospitals, was obtained.

Results: The age of volunteers ranged from 17-60 years, and the mean age was 31.98±9.08 years. More males (62.5%) were represented than females (37.5%). Blood samples were collected, serum samples prepared by centrifugation and stored at -20°C until tested.

The study revealed that out of 180 regular blood donors, all of them tested negative by SD HBsAg ELISA (100%) and out of 180 patients with history of viral hepatitis B, all of them tested positive by SD HBsAg ELISA (100%). Sensitivity, PPV, Specificity, NPV of rapid tests, with respect to SD HBsAg ELISA, exceeded 96%. Vikia HBsAg test performed best in this study, with a relative sensitivity of 99.44%, relative specificity of 99.44%, PPV of 99.44% and NPV of 97.79%. Determine HBsAg showed a relative sensitivity of 98.33%, relative Specificity of 99.44%, PPV of 99.47% and NPV of 98.34%. Acumen HBsAg gave a relative sensitivity of 97.78%, relative specificity of 99.44%, PPV of 99.41% and NPV of 97.79%. There was no significant difference in the sensitivity and specificity of the rapid tests (P=0.63).

Conclusion: Vikia HBsAg test appears to be the most suitable for use in areas with limited resources. Further developments of serological assays should include monoclonal antibodies that recognize epidermiologically relevant surface antigen mutants and further optimization of sensitivity.

Keywords

relative sensitivity relative specificity positive predictive value negative predictive value rapid diagnostic tests hepatitis B surface antigen (HBsAg)

Article Details

How to Cite
Ekwi, D., Fokunang, C., Adiogo, D., & Essame, O. (2013). EVALUATION OF THREE RAPID DIAGNOSTIC TESTS FOR DETECTION OF HEPATITIS B SURFACE ANTIGENS (HBsAg) IN YAOUNDE-CAMEROON. HEALTH SCIENCES AND DISEASE, 11(1). https://doi.org/10.5281/hsd.v11i1.16
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX

References

  1. Chi-jen J. Hepatitis B Surface antigen genotypes and pathogenesis. J Virol 2007;25:108-118.
  2. Don G: Hepatitis B Virus infection-Natural history and clinical consequences. N Engl J Med 2004;350:1118-1129.
  3. Stirk HJ, Thornton CR, Howard C: A Topological model for hepatitis B surface antigen. Intervirology 1992;33:148-158.
  4. Wallace LA, Echavaria JE, Carman WF. Molecular characterization of enveloped antigenic variants of HBV from Spain. J infects Dis 1991170:1300-1303.
  5. Norder HB, Haman D. Comparison of amino acid sequence of nine different serotypes of hepatitis B Surface antigen. J Gen Virol 1992;73:1202-1208.
  6. Clin CL, Kaoj A: HBV Viral factors and clinical outcomes of chronic hepatitis B. J Biomed Sci 2008;15(2): 137-45.
  7. Mogan M, Park W, Keefe EB. Diagnosis and treatment of chronic hepatitis B: an update. Gastroenterology and Hepatology 2007;53(1): 25-41.
  8. Dodson SF, Issa V, Arraya A. Pinna J.R: Infectivity of hepatic allografts with antibodies to HBV. Transplantation 1997;64:1582-1584.
  9. Tolero J. Virological and Clinical significance of HB surface antigen mutants interaction. J Med Virol 2002;1(2):6-9.
  10. Howard CR. The structure of hepatitis B envelope and molecular Variants of hepatitis B Virus. J Viral Hepat 1995;2:165-170.
  11. WHO, Communicable Diseases, Surveillance and Response. Hepatitis B Virus Epidermiology, Disease burden, Treatment, and current emerging prevention and control measures.J Viral 2004.
  12. Fuat KY, Keifuj W, Fuminaka S, Dora M, Leopold K, Nicaise N, Charlotte N, Lazare K. A new subtype (genotype) AC (A3) of hepatitis B virus and recombination between genotypes A and C in Cameroon. J. Gen. Virol 2005;86:2047-2056.
  13. Geller SA. Hepatitis B and C. Clin Liver Dis 2002;6(2):317-34.
  14. Bernadi M, Biselli M, Gramenzi A. Chronic hepatitis B. Recent advances in diagnosis and treatment. Recenti Proqmed 2002;9 (7):397-402.
  15. Anna SF. Characteristics of the Hepatitis B virus and pathogenesis of infection. Hepatitis B Virus 2007;1:16-22.
  16. Kane M. Global programme for control of hepatitis B infection. Vaccine 1995;13(suppl. 1): S47-S49.
  17. Abbot D: Immunochromatograhic assay for detecting HBsAg in human serum or plasma, 2006.
  18. Acumen N: Immunochromatographic assay for detecting HbsAg in human serum, 2007.
  19. Vikia B: Immunochromatographic cassette assay for detecting HBsAg in human serum or plasma, 2008.
  20. Standard DK: Standard Enzyme Linked Immuno Sorbent Assay for detecting HBsAg in serum, 2007.
  21. Marcillat S, Diagbouga S, Chatterjee K, Choudhary M: Evaluation of Vikia HbsAg, a new immuno chromatographic test for the qualitative detection of HBs antigen in serum, plasma and whole human samples. J Clin Microbiol 2007.1 (2):67-74.
  22. Walsh K, Alexander GJ: Update on chronic viral hepatitis. Postgrad Med J 200I; 77(910): 498-505.
  23. Raj AA, Subramaniam T, Raghuraman S, Abraham P. Evaluation of an indigenously manufactured rapid immunochromatographic test for detection of HBsAg. Indian J Pathol Microbiol 2001;44:413-4.

Most read articles by the same author(s)

1 2 > >>