New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 antibodies are very crucial to manage the COVID-19 pandemic, especially in the context of emerging vaccination paradigms. Herein, we report on a novel point-of-care Electrochemical ELISA platform with disposable screen printed electrodes functionalized with SARS-CoV-2 Spike Glycoprotein S1, to enable fast and accurate quantitative estimation of total antibody concentration (IgG and IgM) in clinical samples. The quantification is performed with a comparison of electrochemical redox current against the current produced by the spiked monoclonal antibodies with known concentration. The assay is validated through multicentric evaluation against 3 different FDA authorized Laboratory standard techniques, using both EDTA whole blood and serum samples. We demonstrate that the proposed assay has excellent sensitivity and specificity, making it a suitable candidate for epidemiological surveys and quantification of antibodies in COVID-19 vaccination programs.

用于有效检测和量化 SARS-CoV-2 抗体的新诊断技术对于管理 COVID-19 大流行非常重要，尤其是在新兴疫苗接种范例的背景下。在此，我们报告了一种新型的床旁电化学 ELISA 平台，该平台具有用 SARS-CoV-2 刺突糖蛋白 S1 功能化的一次性丝网印刷电极，能够快速准确地定量估计临床样本中的总抗体浓度（IgG 和 IgM） . 通过比较电化学氧化还原电流与已知浓度的加标单克隆抗体产生的电流来进行量化。该测定通过使用 EDTA 全血和血清样本的 3 种不同的 FDA 授权实验室标准技术进行多中心评估来验证。