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

•New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 Antibodies in clinical samples.•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 es...

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Bibliographic Details
Published in:Journal of virological methods 2021-12, Vol.298, p.114275-114275, Article 114275
Main Authors: Kumar, Vinay, Ghosh, Kanad, Chandran, Anagha, Panwar, Sachin, Bhat, Ananthram, Konaje, Shreenivas, Das, Saroj, Srikanta, S., Jaganathan, Latha, Prasad, Sujay, Venkatesh, D.B., Shivaram, C., Krishnaswamy, P.R., Bhat, Navakanta
Format: Article
Language:English
Subjects:
Antibodies, Viral
COVID-19
COVID-19 Vaccines
Disposable test strips
Electrochemistry
Enzyme-Linked Immunosorbent Assay
Humans
IgG/IgM antibody
Immunoglobulin G
Immunoglobulin M
Pandemics
Point-of-Care Systems
Printed electrodes
SARS-CoV-2
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus
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Summary:•New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 Antibodies in clinical samples.•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 estimation of total antibody concentration (IgG and IgM).•The assay is validated through multicentric evaluation against 3 different FDA authorized Laboratory standard techniques, using both EDTA whole blood and serum samples. 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.
ISSN:0166-0934
1879-0984
DOI:10.1016/j.jviromet.2021.114275