biostudies-literatureUnknownKlumpp-Thomas CCCR NIH HHSNCI NIH HHSThe extent of SARS-CoV-2 infection throughout the United States population is currently unknown. High quality serology is a key tool to understanding the spread of infection, immunity against the virus, and correlates of protection. Limited validation and testing of serology assays used for serosurveys can lead to unreliable or misleading data, and clinical testing using such unvalidated assays can lead to medically costly diagnostic errors and improperly informed public health decisions. Estimating prevalence and clinical decision making is highly dependent on specificity. Here, we present an optimized ELISA-based serology protocol from antigen production to data analysis. This protocol defines thresholds for IgG and IgM for determination of seropositivity with estimated specificity well medRxiv : the preprint server for health sciences2020.05.21.20109280https://www.ebi.ac.uk/biostudies/studies/S-EPMC7265693biostudies-literatureStandardization of enzyme-linked immunosorbent assays for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling.PMC7265693HHSN261200800001EHHSN261200800001CHong MMichael SSadtler KKlumpp-Thomas CFay MPFrank PHicks JGulten GMessing SKalish HSnead KDrew MShunmugavel AHall MDMehalko JMemoli MGillette WDenson JPHunsberger SEsposito DWall VfalseStandardization of enzyme-linked immunosorbent assays for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling.The extent of SARS-CoV-2 infection throughout the United States population is currently unknown. High quality serology is a key tool to understanding the spread of infection, immunity against the virus, and correlates of protection. Limited validation and testing of serology assays used for serosurveys can lead to unreliable or misleading data, and clinical testing using such unvalidated assays can lead to medically costly diagnostic errors and improperly informed public health decisions. Estimating prevalence and clinical decision making is highly dependent on specificity. Here, we present an optimized ELISA-based serology protocol from antigen production to data analysis. This protocol defines thresholds for IgG and IgM for determination of seropositivity with estimated specificity well 2020-01-01T00:00:00Z2020 May2026-05-19T03:11:38.455Z2025-04-04T07:56:08.337ZS-EPMC72656933251147210.1101/2020.05.21.20109280