Development, clinical translation, and utility of a COVID-19 antibody test with qualitative and quantitative readouts

具有定性和定量读数的 COVID-19 抗体测试的开发、临床转化和实用性

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作者:Robert H Bortz 3rd, Catalina Florez, Ethan Laudermilch, Ariel S Wirchnianski, Gorka Lasso, Ryan J Malonis, George I Georgiev, Olivia Vergnolle, Natalia G Herrera, Nicholas C Morano, Sean T Campbell, Erika P Orner, Amanda Mengotto, M Eugenia Dieterle, J Maximilian Fels, Denise Haslwanter, Rohit K Jan

Abstract

The COVID-19 global pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) continues to place an immense burden on societies and healthcare systems. A key component of COVID-19 control efforts is serologic testing to determine the community prevalence of SARS-CoV-2 exposure and quantify individual immune responses to prior infection or vaccination. Here, we describe a laboratory-developed antibody test that uses readily available research-grade reagents to detect SARS-CoV-2 exposure in patient blood samples with high sensitivity and specificity. We further show that this test affords the estimation of viral spike-specific IgG titers from a single sample measurement, thereby providing a simple and scalable method to measure the strength of an individual's immune response. The accuracy, adaptability, and cost-effectiveness of this test makes it an excellent option for clinical deployment in the ongoing COVID-19 pandemic.

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