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检测和定量干血斑中的乙型肝炎表面抗原(HBsAg):一种在偏远地区便于进行乙型肝炎诊断和消除的解决方案。

Detection and quantitation of hepatitis B surface antigen (HBsAg) on dried blood spots: a solution for easy access for hepatitis B diagnosis and elimination in remote areas.

机构信息

Laboratory of Bacteriology Virology, Hospital Center University Aristide Le Dantec, Dakar, Senegal.

Institut de Recherche en Santé de Surveillance Epidémiologique et de Formation, Dakar, Sénégal.

出版信息

Pan Afr Med J. 2022 Jun 7;42:100. doi: 10.11604/pamj.2022.42.100.30531. eCollection 2022.

Abstract

Hepatitis B virus (HBV) is generally endemic in resource-limited countries, which are characterized by a deficit of technical facilities that could delay diagnosis and treatment. To facilitate the accessibility to diagnostic and connection to treatment, evaluation, and promotion of alternatives and/or simplified strategies and inexpensive tools such as dried blood specimens need to be investigated and implemented. This study aimed to evaluate dried blood spots (DBS) for the detection and quantification of HBsAg. This study included 100 DBS from subjects tested positive for HBsAg, and 50 DBSs from subjects tested negative for HBsAg by the automate Architect i1000sr (Abbott Diagnostics, Ireland). Hepatitis B surface antigen detection was performed with determine HBsAg Alere® tests (Alere International Limited, Ireland) and Architect® HBsAg Qualitative II Assays (Abbott, Diagnostics, Ireland) after 15 and 30 days (D15, D30). For HBsAg-positive subjects, the quantification of HBsAg was performed at day zero (D0) from plasma and at D15 and D30 from the DBSs. At D15, the sensitivity and specificity were 96% and 100% for the Determine® tests and 100% and 100% for the Architect® tests, respectively. At D30, the sensitivity and specificity were 96% and 100% for the Determine® tests and 100% and 100% for the Architect® tests, respectively. For HBsAg quantification, the agreement rates were 96%, 96% and 100% between D0-D15, D0-D30 and D15-D30, respectively. This work showed that DBSs can be very useful for HBsAg detection and quantification and therefore in the management of HBV infection in resource-limited settings.

摘要

乙型肝炎病毒(HBV)在资源有限的国家普遍流行,这些国家的特点是缺乏技术设施,可能会延迟诊断和治疗。为了便于获得诊断和治疗、评估以及推广替代方法和/或简化策略以及廉价工具,如干血斑标本,需要对其进行调查和实施。本研究旨在评估干血斑(DBS)用于检测和定量乙型肝炎表面抗原(HBsAg)。本研究包括 100 例经自动化Architect i1000sr(Abbott Diagnostics,爱尔兰)检测为 HBsAg 阳性的 DBS,以及 50 例经检测为 HBsAg 阴性的 DBS。使用 determine HBsAg Alere® 检测(Alere International Limited,爱尔兰)和 Architect® HBsAg 定性 II 检测(Abbott,Diagnostics,爱尔兰)在 15 天(D15)和 30 天(D30)时检测 HBsAg。对于 HBsAg 阳性的受试者,在 D0 时从血浆和 D15 和 D30 时从 DBS 中定量检测 HBsAg。在 D15 时,Determine®检测的灵敏度和特异性分别为 96%和 100%,Architect®检测的灵敏度和特异性分别为 100%和 100%。在 D30 时,Determine®检测的灵敏度和特异性分别为 96%和 100%,Architect®检测的灵敏度和特异性分别为 100%和 100%。对于 HBsAg 定量检测,D0-D15、D0-D30 和 D15-D30 之间的一致性率分别为 96%、96%和 100%。本研究表明,DBS 可非常有助于 HBsAg 的检测和定量,因此可用于资源有限地区的 HBV 感染管理。

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