Background. Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast. Methods. From September 2018 to January 2019, a cross-sectional phase I evaluation study of RDTs was conducted in three laboratories of Abidjan (CeDReS, CNTS and IPCI), on a panel of 405 whole blood samples and 699 plasmas. Four HBsAg RDTs (Determine™ HBsAg, SD Bioline HBsAg WB®, Standard Q HBsAg® and Vikia HBsAg®) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg® one version ULTRA and Monolisa™ HBsAg ULTRA). Results. The Determine™ HBsAg and Vikia HBsAg® tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB® and Standard Q HBsAg®, the specificities were 99.8% and the sensitivities 99.3% and 97.1% respectively. Finally, there were a total of 19 false negative results: 3 with SD Bioline HBsAg WB® and 16 with Standard Q HBsAg®. Conclusion. Determine HBsAg® from Alere and Vikia HBsAg® from Biomérieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.

中文翻译：

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科特迪瓦乙型肝炎表面抗原检测的四种快速检测方法的评价。

背景。乙型肝炎病毒 (HBV) 感染是全球肝病的主要原因。乙型肝炎表面抗原 (HBsAg) 快速诊断测试 (RDT) 可能是在流行性高但基础设施有限的环境中进行大规模 HBV 筛查的理想工具。本研究的目的是评估此类 RDT 在科特迪瓦筛查 HBV 感染中的诊断性能。方法。从 2018 年 9 月到 2019 年 1 月，在阿比让的三个实验室（CeDReS、CNTS 和 IPCI）对 405 个全血样本和 699 个血浆进行了 RDT 的横断面 I 期评估研究。评估了四种 HBsAg RDT（Determine™ HBsAg、SD Bioline HBsAg WB®、Standard Q HBsAg® 和 Vikia HBsAg®）。与两个 EIA 测试（Dia.Pro HBsAg® one version ULTRA 和 Monolisa™ HBsAg ULTRA）的参考顺序算法相比，计算了诊断性能（敏感性和特异性）。结果. 确定™ HBsAg 和 Vikia HBsAg® 测试表现良好，对血浆和全血均具有 100% 的灵敏度和特异性。对于 SD Bioline HBsAg WB® 和 Standard Q HBsAg®，特异性分别为 99.8%，敏感性分别为 99.3% 和 97.1%。最后，共有 19 个假阴性结果：3 个为 SD Bioline HBsAg WB®，16 个为 Standard Q HBsAg®。结论。确定 Alere 的 HBsAg® 和 Biomérieux 的 Vikia HBsAg® 是科特迪瓦筛查 HBV 最合适的 RDT。必须启动第二阶段评估。