Abstract
Severe acute respiratory coronavirus-2 (SARS-CoV-2) is a novel viral pathogen and therefore a challenge to accurately diagnose infection. Asymptomatic cases are common and so it is difficult to accurately identify infected cases to support surveillance and case detection. Diagnostic test developers are working to meet the global demand for accurate and rapid diagnostic tests to support disease management. However, the focus of many of these has been on molecular diagnostic tests, and more recently serologic tests, for use in primarily high-income countries. Low- and middle-income countries typically have very limited access to molecular diagnostic testing due to fewer resources. Serologic testing is an inappropriate surrogate as the early stages of infection are not detected and misdiagnosis will promote continued transmission. Detection of infection via direct antigen testing may allow for earlier diagnosis provided such a method is sensitive. Leading SARS-CoV-2 biomarkers include spike protein, nucleocapsid protein, envelope protein, and membrane protein. This research focuses on antibodies to SARS-CoV-2 spike protein due to the number of monoclonal antibodies that have been developed for therapeutic research but also have potential diagnostic value. In this study, we assessed the performance of antibodies to the spike glycoprotein, acquired from both commercial and private groups in multiplexed liquid immunoassays, with concurrent testing via a half-strip lateral flow assays (LFA) to indicate antibodies with potential in LFA development. These processes allow for the selection of pairs of high-affinity antispike antibodies that are suitable for liquid immunoassays and LFA, some of which with sensitivity into the low picogram range with the liquid immunoassay formats with no cross-reactivity to other coronavirus S antigens. Discrepancies in optimal ranking were observed with the top pairs used in the liquid and LFA formats. These findings can support the development of SARS-CoV-2 LFAs and diagnostic tools.
Highlights
The appearance of a novel coronavirus disease 2019 (COVID19) was first reported in the city of Wuhan, Hubei Province, China in 2019.1 As of March 11, 2021, the COVID-19 pandemic has continued to progress with over 178 million reported cases including over 3.8 million associated deaths globally.[2]
The S glycoprotein is poorly conserved across coronaviruses, with 85.3% of the antibody epitopes found in SARS-CoV-2 S protein considered unique.[6,7]
A total of 48 monoclonal antibodies (AbCellera, 41; Sino Biological, 3; and Leinco, 4) were assessed for their performance as capture and detection antibodies for the SARS-CoV-2 S glycoprotein across three rounds of testing using the Meso Scale Discovery (MSD) U-PLEX assay platform
Summary
The appearance of a novel coronavirus disease 2019 (COVID19) was first reported in the city of Wuhan, Hubei Province, China in 2019.1 As of March 11, 2021, the COVID-19 pandemic has continued to progress with over 178 million reported cases including over 3.8 million associated deaths globally.[2]. The S glycoprotein is poorly conserved across coronaviruses, with 85.3% of the antibody epitopes found in SARS-CoV-2 S protein considered unique.[6,7] higher conservation noted across SARS-CoV-2 isolates from Europe, Asia, and the United States, resulting in an antigen that offers greater
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