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. 2021 Dec:298:114275.
doi: 10.1016/j.jviromet.2021.114275. Epub 2021 Sep 13.

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

Vinay Kumar  1 , Kanad Ghosh  2 , Anagha Chandran  2 , Sachin Panwar  2 , Ananthram Bhat  2 , Shreenivas Konaje  2 , Saroj Das  3 , S Srikanta  4 , Latha Jaganathan  5 , Sujay Prasad  6 , D B Venkatesh  6 , C Shivaram  7 , P R Krishnaswamy  3 , Navakanta Bhat  8
Affiliations

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

Vinay Kumar et al. J Virol Methods. 2021 Dec.

Abstract

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.

Keywords: COVID-19; Disposable test strips; Electrochemistry; IgG/IgM antibody; Printed electrodes; SARS-CoV-2.

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Conflict of interest statement

Vinay Kumar and Navakanta Bhat are the co-founders of PathShodh Healthcare Pvt. Ltd., a start-up incubated at the Indian Institute of Science, Bengaluru. They are also the co-inventors on a US patent application 17/228,798, on this technology.

Figures

Fig. 1
Fig. 1
(a) The carbon printed disposable test strip with two working electrodes (W), one counter (C) and one reference electrode (R); (b) Handheld ELISA analyser with an inserted test strip; (c) Representative reduction current response in buffer solution without antibody and with antibody. Note: Higher the antibody concentration in the sample, lower will be the redox current.
Fig. 2
Fig. 2
Change in peak reduction current in EDTA whole blood samples as a function of Spiked (a) IgG, & (b) IgM concentration. For each data point, at least three trials are conducted and their standard deviations are plotted. The reduction current is observed to be decreasing exponentially with increase in antibody concentration.
Fig. 3
Fig. 3
Change in peak reduction current in serum samples as a function of Spiked (a) IgG & (b) IgM concentration. For each data point, at least three trials are conducted and their standard deviations are plotted.
Fig. 4
Fig. 4
Correlation between anuPath™ electrochemical analyzer and lab analyzer in quantification of SARS-CoV-2 antibody concentration in (a) EDTA blood & (b) serum samples. The gold standard antibody concentration (AU/mL) is found to be in excellent agreement with the anuPath™ analyser.
Fig. 5
Fig. 5
Bland Altman analysis for agreement in two assays (a) EDTA blood & (b) serum.
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