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The FDA’s Experience with Covid-19 Antibody Tests

Jeffrey Shuren, Timothy T. Stenzel

2021New England Journal of Medicine31 citationsDOI

Abstract

The FDA’s Experience with Covid-19 Antibody Tests Early in the pandemic, the FDA recognized that ensuring access to antibody tests could advance understanding of Covid-19 and help inform the nation...

Topics & Concepts

Coronavirus disease 2019 (COVID-19)Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)2019-20 coronavirus outbreakPandemicVirologyAntibodyMedicineImmunologyInternal medicineOutbreakInfectious disease (medical specialty)DiseaseSARS-CoV-2 and COVID-19 ResearchBiomedical Ethics and RegulationBiosimilars and Bioanalytical Methods
The FDA’s Experience with Covid-19 Antibody Tests | Litcius