FDA Authorizes First Quantitative Serology Test

Serology tests traceable to a certified reference material may be helpful for ongoing research to study COVID-19 immune response.

If your email program has trouble displaying this email, view as a webpage. COVID-19 Update: FDA Authorizes First Quantitative Serology Test  Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Ortho-Clinical Diagnostics, Inc., for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test. Quantitative serology tests that are traceable to a certified reference material may be helpful for ongoing medical research to study the immune response to SARS-CoV-2.  The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative test:  Measures IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, from an individual's blood sample (serum and plasma) to aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection.   Test results are standardized (traceable) to an international standard reference material.   Should not be used to diagnose current SARS-CoV-2 infection.  Should not be used to assess for immunity to COVID-19 after COVID-19 vaccination or to assess the need for a person who is not vaccinated to receive vaccination.  Read More Questions? If you have questions about this test, email COVID19DX@fda.hhs.gov.

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