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Evaluation of the Diagnostic Performances of the SD Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso
Dera, A.; Sanou, A.M.; Ouattara, M.N.G.; Ilboudo, A.K.; Lankoande, D.B.; Ilboudo, D.; Napon-Zongo, D.; Gomgnimbou, M.K. Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso. Diagnostics 2023, 13, 3144, doi:10.3390/diagnostics13193144.
Dera, A.; Sanou, A.M.; Ouattara, M.N.G.; Ilboudo, A.K.; Lankoande, D.B.; Ilboudo, D.; Napon-Zongo, D.; Gomgnimbou, M.K. Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso. Diagnostics 2023, 13, 3144, doi:10.3390/diagnostics13193144.
Dera, A.; Sanou, A.M.; Ouattara, M.N.G.; Ilboudo, A.K.; Lankoande, D.B.; Ilboudo, D.; Napon-Zongo, D.; Gomgnimbou, M.K. Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso. Diagnostics 2023, 13, 3144, doi:10.3390/diagnostics13193144.
Dera, A.; Sanou, A.M.; Ouattara, M.N.G.; Ilboudo, A.K.; Lankoande, D.B.; Ilboudo, D.; Napon-Zongo, D.; Gomgnimbou, M.K. Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso. Diagnostics 2023, 13, 3144, doi:10.3390/diagnostics13193144.
Abstract
Hepatitis B e antigen (HBeAg) is a marker of wild-type hepatitis B virus replication. In resource-limited countries where access to enzyme-linked immunosorbent assay (ELISA) remains a challenge, rapid diagnostic tests (RDT) constitute a good alternative. The HBeAg status is employed to evaluate eligibility for antiviral therapy and to prevent the transmission of hepatitis B from mother to child (PMTCT). The objective of this study was to assess the diagnostic performance of the SD-Bioline®HBeAg RDT commonly used for detecting HBeAg in laboratories in Burkina Faso. The sample panel used was collected from HBsAg positive patients received in the laboratory for the detection of HBeAg with the rapid test. The samples were retested for HBeAg using the VIDAS HBe/Anti-HBe enzyme-linked fluorescent assay (ELFA) (Gold standard). Then, the viral load (VL) of HBV DNA was determined using the GENERIC HBV CHARGE VIRLAE kit (GHBV-CV). The diagnostic performances of the SD-Bioline®HBeAg and its agreement with the gold standard were calculated with their 95% confidence intervals. 340 sera obtained from HBsAg positive patients were included in this evaluation Compared to the VIDAS HBe/Anti-HBe ELFA test, the sensitivity (Se) and specificity (Sp) of the SD-Bioline®HBeAg test were 33.3% and 97.9% respectively. The concordance between the two tests was 0.42. Depending on the viral load, the Se and Sp varied from 8.8% and 98.3% for a VL < 2,000 IU/mL to 35.5% and 98.4% for a VL > 2,000,000 IU/mL. The results showed a low Sensibility of the SD-Bioline®HBeAg RDT test, indicating that its use is inappropriate for the clinical management of HBV-infected patients. They also highlight the urgent need to develop HBeAg rapid tests with better sensitivities.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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