EVALUATION OF THREE RAPID DIAGNOSTIC TESTS FOR DETECTION OF HEPATITIS B SURFACE ANTIGENS (HBsAg) IN YAOUNDE-CAMEROON.

DN Ekwi, Charles Fokunang, D Adiogo, O Essame

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)

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