Multicentric evaluation of a novel point of care electrochemical ELISA platform for SARS-CoV-2 specific IgG and IgM antibody assay

Abstract

New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 Antibodies is 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.

Update on Rapid Diagnostics for COVID-19: A Systematic Review

“…Lower sensitivity values were observed in the first days after infection [57,61,62,64] than the days postinfection. Accuracy was reported in three studies [56,63,65], and values lower than 80% were found only in the study by Fauziah et al [62]. The accuracy of 100% was verified in the study by Kumar et al [56].…”

“…Accuracy was reported in three studies [56,63,65], and values lower than 80% were found only in the study by Fauziah et al [62]. The accuracy of 100% was verified in the study by Kumar et al [56].…”

“…Among the 13 selected studies, 10 presented high values of sensitivity and specificity (>80%) [56][57][58]60,61,[64][65][66][67][68], and 1 reported 100% of sensitivity and specificity [56]. Lower sensitivity values were observed in the first days after infection [57,61,62,64] than the days postinfection.…”

“…Regarding immunoglobulin detection tests, we identified nine studies that assessed IgM and IgG levels [56][57][58][59][60][61][62][63][64], three evaluating only IgG [65][66][67], and one evaluating IgA, IgG, and IgM [68]. A total of 10 antibody tests were performed by lateral-flow assays (considering gold and fluorescence assays) [57][58][59][60][61][62][63][64][65]68], 1 by electrochemical enzyme immunoassay (ELISA) [56], 1 by magnetofluidic immuno-PCR platform [66], and 1 by the Split Luciferase (spLUC) antibody sensor [67].…”

A comparison of conventional and advanced electroanalytical methods to detect SARS-CoV-2 virus: A concise review

“…Furthermore, their method necessitated a lengthy process of surface functionalization, sample preparation, and testing, making it unsuitable for PoC testings. Therefore, to overcome these issues, Kumar et al (2021) reported a new PoC electrochemical ELISA technology that uses disposable screen-printed electrodes functionalized with SARS-CoV-2 Spike glycoprotein S1 to allow for quick and reliable quantification of total IgG and IgM concentrations in clinical samples. This new technique has been thoroughly validated over multicentric evaluation at four centers.…”