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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
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 elig...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10572218/ https://www.ncbi.nlm.nih.gov/pubmed/37835887 http://dx.doi.org/10.3390/diagnostics13193144 |
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author | Dera, Abdoulaye Sanou, Armel M. Ouattara, Mathuola N. G. Ilboudo, Abdoul K. Lankoande, David B. Ilboudo, Dieudonné Napon-Zongo, Delphine Gomgnimbou, Michel K. |
author_facet | Dera, Abdoulaye Sanou, Armel M. Ouattara, Mathuola N. G. Ilboudo, Abdoul K. Lankoande, David B. Ilboudo, Dieudonné Napon-Zongo, Delphine Gomgnimbou, Michel K. |
author_sort | Dera, Abdoulaye |
collection | PubMed |
description | 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. Overall, 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 < 2000 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. |
format | Online Article Text |
id | pubmed-10572218 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-105722182023-10-14 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, Abdoulaye Sanou, Armel M. Ouattara, Mathuola N. G. Ilboudo, Abdoul K. Lankoande, David B. Ilboudo, Dieudonné Napon-Zongo, Delphine Gomgnimbou, Michel K. Diagnostics (Basel) Article 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. Overall, 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 < 2000 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. MDPI 2023-10-07 /pmc/articles/PMC10572218/ /pubmed/37835887 http://dx.doi.org/10.3390/diagnostics13193144 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Dera, Abdoulaye Sanou, Armel M. Ouattara, Mathuola N. G. Ilboudo, Abdoul K. Lankoande, David B. Ilboudo, Dieudonné Napon-Zongo, Delphine Gomgnimbou, Michel 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 |
title | Evaluation of the Diagnostic Performances of the SD-Bioline(®)HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso |
title_full | Evaluation of the Diagnostic Performances of the SD-Bioline(®)HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso |
title_fullStr | Evaluation of the Diagnostic Performances of the SD-Bioline(®)HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso |
title_full_unstemmed | Evaluation of the Diagnostic Performances of the SD-Bioline(®)HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso |
title_short | Evaluation of the Diagnostic Performances of the SD-Bioline(®)HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso |
title_sort | evaluation of the diagnostic performances of the sd-bioline(®)hbeag rapid test used routinely for the management of hbv-infected individuals in burkina faso |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10572218/ https://www.ncbi.nlm.nih.gov/pubmed/37835887 http://dx.doi.org/10.3390/diagnostics13193144 |
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