EPHA Conference Systems, 32nd EPHA Annual Conference

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Development, Optimization and Validation of an In-house Enzyme Linked Immunosorbent assay (ELISA) for anti–SARS-CoV-2 receptor binding domain (RBD) of the spike protein immunoglobulin G (IgG)
Tesfaye Gelanew

Last modified: 2021-03-05

Abstract


Currently, hundreds of commercial COVID-19 antibody tests are available. However, majority of them lack validation and evaluation of their sensitivity and specificity in large-scale studies. Due to the sensitivity and specificity, SARS-CoV-2 receptor binding domain (RBD) of the spike protein antigen based serologic tests have gained a global popularity. We therefore have developed, optimized and validated an in-house Enzyme Linked Immunosorbent assay (ELISA) for anti–SARS-CoV-2 RBD immunoglobulin G (IgG). The developed assay has a sensitivity and specificity comparable to the eleven commercially available point-of-care-style lateral flow assays (LFAs), seven laboratory-based tests and four in-house tests that detect anti-SARS-CoV-2 IgM, IgG and/or total antibodies evaluated in larger number of clinical samples and published in Nature. This makes our assay reliable to more accurately estimate SARS-CoV-2 prevalence and incidence in different settings such as in health care facilities, schools and communities. Additionally, our IgG ELISA works perfect in easy-to collect and cost-effective matrices such as dried blood spots (DBS) and saliva, which makes our assay more suitable for conducting serosurvey that involves mass screening in resource limited settings. More importantly, besides being affordable antibody test, our assay has a huge potential to overcome the long delays associated with sourcing in commercially available antibody tests from international suppliers or venders.