Published in
American Society for Microbiology, Journal of Clinical Microbiology, 10(59), 2021
DOI: 10.1128/jcm.01167-21
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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
Journal article published in 2021 by
David R. Peaper 
,
Daniel D. Rhoads,
Kaede V. Sullivan,
Marc R. Couturier,
Romney M. Humphries ,
Isabella W. Martin,
Frederick S. Nolte ,
Marie-Claire Rowlinson,
Rosemary C. She,
Patricia J. Simner ,
Elitza S. Theel ,
Christina M. Wojewoda ,
Alexander J. McAdam
,
Daniel D. Rhoads,
Kaede V. Sullivan,
Marc R. Couturier,
Romney M. Humphries ,
Isabella W. Martin,
Frederick S. Nolte ,
Marie-Claire Rowlinson,
Rosemary C. She,
Patricia J. Simner ,
Elitza S. Theel ,
Christina M. Wojewoda ,
Alexander J. McAdam
This paper is made freely available by the publisher.
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Abstract
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.