Update: Authorized Serology Test Performance

This updated FDA web page provides NPV and PPV estimates at more COVID-19 prevalence levels; clarifies adaptive immune response.

If your email program has trouble displaying this email, view as a webpage. FDA Updates Authorized Serology Test Performance On April 28, 2021, the U.S. Food and Drug Administration (FDA) updated the EUA Authorized Serology Test Performance page on the FDA's website. The FDA provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients.  Additionally, the updated web page clarifies the use of serology tests when assessing a patient's adaptive immune response. See the Update Questions? If you have questions, please email COVID19DX@fda.hhs.gov

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