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


Journal

Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564

Informations de publication

Date de publication:
20 09 2021
Historique:
pubmed: 15 7 2021
medline: 24 9 2021
entrez: 14 7 2021
Statut: ppublish

Résumé

The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers'

Identifiants

pubmed: 34260276
doi: 10.1128/JCM.01167-21
pmc: PMC8451421
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0116721

Subventions

Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States

Références

Clin Microbiol Rev. 2010 Jul;23(3):550-76
pubmed: 20610823
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32381642

Auteurs

David R Peaper (DR)

Department of Laboratory Medicine, Yale School of Medicinegrid.471390.8, New Haven, Connecticut, USA.

Daniel D Rhoads (DD)

Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.

Kaede V Sullivan (KV)

Department of Pathology and Laboratory Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, USA.

Marc R Couturier (MR)

Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA.

Romney M Humphries (RM)

Department of Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.

Isabella W Martin (IW)

Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.

Frederick S Nolte (FS)

Department of Pathology and Laboratory Medicine, Medical University of South Carolinagrid.259828.c, Charleston, South Carolina, USA.

Marie-Claire Rowlinson (MC)

Florida Department of Healthgrid.410382.c, Bureau of Public Health Laboratories, Jacksonville, Florida, USA.

Rosemary C She (RC)

Department of Pathology, Keck School of Medicine of the University of Southern California, Los Angeles, California, USA.

Patricia J Simner (PJ)

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Elitza S Theel (ES)

Department of Laboratory Medicine and Pathology, Mayo Clinicgrid.66875.3a, Rochester, Minnesota, USA.

Christina M Wojewoda (CM)

Department of Pathology and Laboratory Medicine, University of Vermont Medical Centergrid.414924.e, Burlington, Vermont, USA.

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Classifications MeSH