Considerations from the College of American Pathologists for Implementation of an Assay for SARS-CoV-2 Testing after a Change in Regulatory Status-Reference-Cited by-同舟云学术

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

Published:2021-09-20 Issue:10 Volume:59 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Peaper David R.¹^ORCID,Rhoads Daniel D.²,Sullivan Kaede V.³,Couturier Marc R.⁴,Humphries Romney M.⁵^ORCID,Martin Isabella W.⁶,Nolte Frederick S.⁷^ORCID,Rowlinson Marie-Claire⁸,She Rosemary C.⁹,Simner Patricia J.¹⁰^ORCID,Theel Elitza S.¹¹^ORCID,Wojewoda Christina M.¹²^ORCID

Affiliation:

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

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

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

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

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

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

7. Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina, USA

8. Florida Department of Health, Bureau of Public Health Laboratories, Jacksonville, Florida, USA

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

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

11. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA

12. Department of Pathology and Laboratory Medicine, University of Vermont Medical Center, Burlington, Vermont, USA

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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01167-21

Reference4 articles.

1. Validation of Laboratory-Developed Molecular Assays for Infectious Diseases

2. College of American Pathologists, Commission on Laboratory Accreditation. 2020. All commend checklist:COM.40300. College of American Pathologists, Northfield, IL.

3. Code of Federal Regulations. 2009. Title 42. Public Health, Vol. 4, Chapter V. Health Care Financing Administration, Department of Health and Human Services, part 493. Laboratory Requirements, Section 493.1253. Standard: establishment and verification of performance specifications. U.S. Government Printing Office, Washington, DC.

4. Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA

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