Laboratoire de Virologie, Unité des Maladies à Potentiel épidémiques, Maladies émergentes et Zoonoses, Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.
Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (Iressef), Arrondissement 4 Rue 2 D1, Diamniadio, Senegal; Institut National de la santé et de la Recherche Médicale (Inserm), U1052, CRCL, 151 Cours Albert Thomas, 69003, Lyon, France.
J Clin Virol. 2020 Aug;129:104546. doi: 10.1016/j.jcv.2020.104546. Epub 2020 Jul 7.
In limited resources countries, HBsAg-rapid diagnostic test (RDT) represents a good alternative for the diagnosis of hepatitis B virus (HBV) infection. Due to many factors that can influence their analytical performances, an evaluation with local biological samples before using on a large scale is recommended.
The aims of the study were: (i) to evaluate the analytical performance of eight commercial RDTs used in Burkina Faso for the detection of HBsAg using serum from blood donors, and (ii) to propose an algorithm using these RDTs based on their analytical performance.
109 HBsAg-positive and 216 HBsAg-negative samples were included in this evaluation. A modified version of the World Health Organization (WHO) algorithm for the detection of HBsAg was used as the gold standard. A pairwise combination of RDTs performance was done to choose the best diagnostic algorithm.
All RDTs presented an excellent specificity (Sp) (≥99.0 %) except Accucare HBsAg® test. Sensitivity (Se) ranged from 90.8 % (95 % CI: 87.9-93.7) for Rapid Signal™ HBsAg to 92.8 % (95 % CI: 90.3-95.5) for SD BioLine® HBsAg and Artron® HBsAg. The pairwise combinations of the Se and Sp of RDTs showed no improvement in diagnostic performance.
The RDTs evaluated in this study have good sensitivities and excellent specificities indicating their use in clinical practice and for HBV mass screening in Burkina Faso. However, their use should be monitored in the context of blood transfusion. Furthermore, according to our algorithm, each positive sample should be confirmed by another RDT of good Se.
在资源有限的国家，HBsAg 快速诊断检测（RDT）是诊断乙型肝炎病毒（HBV）感染的良好替代方法。由于许多因素会影响其分析性能，因此建议在大规模使用之前，使用当地的生物样本进行评估。
本研究的目的是：（i）评估在布基纳法索使用的八种商业 RDT 在检测 HBsAg 时对献血者血清的分析性能，（ii）根据其分析性能提出一种基于这些 RDT 的算法。
本评估纳入了 109 份 HBsAg 阳性和 216 份 HBsAg 阴性样本。采用世界卫生组织（WHO）用于检测 HBsAg 的改良算法作为金标准。对 RDT 性能进行两两组合，以选择最佳诊断算法。
除 Accucare HBsAg®检测外，所有 RDT 的特异性（Sp）均表现出极好的表现（≥99.0%）。灵敏度（Se）范围从 Rapid Signal™ HBsAg 的 90.8%（95%CI：87.9-93.7）到 SD BioLine® HBsAg 和 Artron® HBsAg 的 92.8%（95%CI：90.3-95.5）。RDT 的 Se 和 Sp 的两两组合显示在诊断性能方面没有提高。
本研究评估的 RDT 具有良好的灵敏度和极好的特异性，表明它们可在布基纳法索的临床实践和 HBV 大规模筛查中使用。然而，在输血背景下，应监测其使用情况。此外，根据我们的算法，每个阳性样本都应通过另一种具有良好 Se 的 RDT 来确认。
