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Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status

The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers’ in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2. The U.S. government’s Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulates the studies that a clinical diagnostic...

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Detalles Bibliográficos
Autores principales:	Peaper, David R., Rhoads, Daniel D., Sullivan, Kaede V., Couturier, Marc R., Humphries, Romney M., Martin, Isabella W., Nolte, Frederick S., Rowlinson, Marie-Claire, She, Rosemary C., Simner, Patricia J., Theel, Elitza S., Wojewoda, Christina M.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Society for Microbiology 2021
Materias:	Commentary
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451421/ https://www.ncbi.nlm.nih.gov/pubmed/34260276 http://dx.doi.org/10.1128/JCM.01167-21

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