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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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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:
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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author 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.
author_facet 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.
author_sort Peaper, David R.
collection PubMed
description 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 laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization (EUA) pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated, in order to continue to be marketed as an IVD in the United States. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.
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spelling pubmed-84514212021-10-04 Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status 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. J Clin Microbiol Commentary 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 laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization (EUA) pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated, in order to continue to be marketed as an IVD in the United States. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status. American Society for Microbiology 2021-09-20 /pmc/articles/PMC8451421/ /pubmed/34260276 http://dx.doi.org/10.1128/JCM.01167-21 Text en Copyright © 2021 American Society for Microbiology. https://doi.org/10.1128/ASMCopyrightv2All Rights Reserved (https://doi.org/10.1128/ASMCopyrightv2) . https://doi.org/10.1128/ASMCopyrightv2This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Commentary
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.
Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title_full Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title_fullStr Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title_full_unstemmed Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title_short Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status
title_sort considerations from the college of american pathologists for implementation of an assay for sars-cov-2 testing after a change in regulatory status
topic Commentary
url 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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