Screening Antibodies Raised Against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

Cantera, Jason L.; Cate, David M.; Golden, Allison; Peck, Roger; Lillis, Lorraine; Domingo, Gonzalo J.; Murphy, Eileen F.; Barnhart, Bryan C.; Anderson, Caitlin; Alonzo, Luis F.; Glukhova, Veronika; Hermansky, Gleda; Barrios-Lopez, Brianda; Spencer, Ethan; Kuhn, Samantha; Islam, Zeba; Grant, Benjamin D.; Kraft, Lucas; Hervé, Karine; Puyraimond, Valentine de; Hwang, Yuri; Dewan, Puneet; Weigl, Bernhard H.; Nichols, Kevin P.; Boyle, David

doi:10.26434/chemrxiv.12899672.v1

Cited by 3 publications

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“…All data generated from this screening is publicly accessible. 30 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. Each well in a 96-well U-PLEX plate can host 10 different capture antibodies per well in a geometric planar array (960 capture events per plate).…”

Section: Resultsmentioning

confidence: 99%

Screening Antibodies Raised against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

et al. 2021

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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.

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Section: Resultsmentioning

confidence: 99%

Screening Antibodies Raised against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

et al. 2021

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“…32,35 The S antigen assay used antibody pairs 447 (AbCellera Biologics Inc., Vancouver, Canada) and 40591-MM43 (Sino Biological, Wayne, USA). 36 Plates were read on a MESO QuickPlex SQ 120 plate reader (MesoScale Diagnostics, Rockville, USA) for quantitative concentrations. We fitted a four-parameter logistic function and calculated limits of detection (LOD).…”

Section: Methodsmentioning

confidence: 99%

Duration of viral infectiousness and correlation with symptoms and diagnostic testing in non-hospitalized adults during acute SARS-CoV-2 infection: A longitudinal cohort study

Drain

Dalmat

Hao

et al. 2022

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Background: Guidelines for SARS-CoV-2 have relied on limited data on duration of viral infectiousness and correlation with COVID-19 symptoms and diagnostic testing. Methods: We enrolled ambulatory adults with acute SARS-CoV-2 infection and performed serial measurements of COVID-19 symptoms, nasal swab viral RNA, nucleocapsid (N) and spike (S) antigens, and replication-competent SARS-CoV-2 by culture. We determined average time from symptom onset to a first negative test result and estimated risk of infectiousness, as defined by a positive viral culture. Results: Among 95 adults, median [interquartile range] time from symptom onset to first negative test result was 9 [5] days, 13 [6] days, 11 [4] days, and >19 days for S antigen, N antigen, viral culture growth, and viral RNA by RT-PCR, respectively. Beyond two weeks, viral cultures and N antigen titers were rarely positive, while viral RNA remained detectable among half (26/51) of participants tested 21-30 days after symptom onset. Between 6-10 days from symptom onset, N antigen was strongly associated with viral culture positivity (relative risk=7.61, 95% CI: 3.01-19.2), whereas neither viral RNA nor symptoms were associated with culture positivity. During the 14 days following symptom onset, presence of N antigen (adjusted relative risk=7.66, 95% CI: 3.96-14.82), remained strongly associated with viral culture positivity, regardless of COVID-19 symptoms. Conclusions: Most adults have replication-competent SARS-CoV-2 for 10-14 after symptom onset, and N antigen testing is a strong predictor of viral infectiousness. Within two weeks from symptom onset, N antigen testing, rather than absence of symptoms or viral RNA, should be used to safely discontinue isolation.

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Point-of-care diagnostics: recent developments in a pandemic age

et al. 2021

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Screening Antibodies Raised Against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

Cited by 3 publications

References 15 publications

Screening Antibodies Raised against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

Screening Antibodies Raised against the Spike Glycoprotein of SARS-CoV-2 to Support the Development of Rapid Antigen Assays

Duration of viral infectiousness and correlation with symptoms and diagnostic testing in non-hospitalized adults during acute SARS-CoV-2 infection: A longitudinal cohort study

Point-of-care diagnostics: recent developments in a pandemic age

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