Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Sanou, Armel M.; Nikièma, Achille S.; Zalla, Seimbou; Ouattara, Mamadou; Dakouo, Nina Pascaline S.; Kiba‐Koumare, Alice; Seynou, Mariam; Napon-Zongo, D.; Sombié, Roger

doi:10.1002/hsr2.748

Cited by 3 publications

(1 citation statement)

References 24 publications

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“…Due to their low cost and ease of use, RDTs are widely used in resource-limited countries. Although offering advantages, the diagnostic performances of RDTs can be influenced by factors such as low detection limits and genetic diversity [10,11]. Therefore, it is necessary to evaluate these RDTs with local biological samples before their widespread use.…”

Section: Introductionmentioning

confidence: 99%

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,

Sanou,

Ouattara

et al. 2023

Diagnostics

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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.

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Section: Introductionmentioning

confidence: 99%

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,

Sanou,

Ouattara

et al. 2023

Diagnostics

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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,

SANOU,

OUATTARA

et al. 2023

Preprint

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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 &lt; 2,000 IU/mL to 35.5% and 98.4% for a VL &gt; 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.

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Occult Hepatitis B Virus Infection: A Killer Hidden in Transfused Blood, Sudan

Ahmed¹,

Mohammed²,

Elshafia³

et al. 2022

JBM

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Introduction: Transmission of hepatitis B virus (HBV) through the blood is a significant risk, especially in poor countries with high endemicity. Occult transmission of HBV (OBI) is an important acquisition scenario. Objective: A cross-sectional laboratory-based study followed to detect OBI in blood of accepted donors admitted to Mad Medani Blood Bank, Sudan. Methods: During the study, 200 accepted blood units were examined for HBsAg by ELISA technique and negative samples were tested for total anti-HBc antibodies using electroluminescence immunoassay (ECLIAS). HBV DNA amplification was performed for units that showed total anti-Hbc positivity. Results: Of the 200 blood units, 3 appeared positive by ELISA. Total anti-HBc antibodies were present in 34% (67/197) of blood units. HBV DNA was successfully amplified in 52.2% (35/67) of total anti-HBc positive samples. A significant association was observed between reactive total anti-HBc and age group (p < 0.001), marital status (p < 0.001) and HBV vaccination (p-value 0.012) of blood donors. Conclusion: OBI was recorded at a high rate in the blood of donors, which necessitates the implementation of detection methods to protect the recipients.

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Residual risk of hepatitis B virus transmission through blood donations in Burkina Faso screened with rapid diagnostic tests

Cited by 3 publications

References 24 publications

Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso

Evaluation of the Diagnostic Performances of the SD-Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso

Evaluation of the Diagnostic Performances of the SD Bioline®HBeAg Rapid Test Used Routinely for the Management of HBV-Infected Individuals in Burkina Faso

Occult Hepatitis B Virus Infection: A Killer Hidden in Transfused Blood, Sudan

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