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Understanding, Verifying, and Implementing Emergency Use Authorization Molecular Diagnostics for the Detection of SARS-CoV-2 RNA.
Mitchell, Stephanie L; St George, Kirsten; Rhoads, Daniel D; Butler-Wu, Susan M; Dharmarha, Vaishali; McNult, Peggy; Miller, Melissa B.
  • Mitchell SL; Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
  • St George K; Laboratory of Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, New York, USA.
  • Rhoads DD; University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
  • Butler-Wu SM; Department of Pathology, Keck School of Medicine of USC, Los Angeles, California, USA.
  • Dharmarha V; American Society for Microbiology, Washington, DC, USA.
  • McNult P; American Society for Microbiology, Washington, DC, USA.
  • Miller MB; University of North Carolina School of Medicine, Department of Pathology and Laboratory Medicine, Chapel Hill, North Carolina, USA Melissa.Miller@unchealth.unc.edu.
J Clin Microbiol ; 58(8)2020 Jul 23.
Article in English | MEDLINE | ID: covidwho-999196
ABSTRACT
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has brought a new wave of challenges to health care, particularly in the area of rapid diagnostic test development and implementation. The diagnosis of acute coronavirus disease 2019 (COVID-19) is critically dependent on the detection of SARS-CoV-2 RNA from clinical specimens (e.g., nasopharyngeal swabs). While laboratory-developed testing for SARS-CoV-2 is an essential component of diagnostic testing for this virus, the majority of clinical microbiology laboratories are dependent on commercially available SARS-CoV-2 molecular assays. In contrast to assays approved or cleared by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use, assays for the detection of SARS-CoV-2 nucleic acids have emergency use authorization (EUA) from the FDA. Outside of highly specialized academic and commercial laboratory settings, clinical microbiology laboratories are likely unfamiliar with the EUA classification, and thus, assay verification can be daunting. Further compounding anxiety for laboratories are major issues with the supply chain that are dramatically affecting the availability of test reagents and requiring laboratories to implement multiple commercial EUA tests. Here, we describe guidance for the verification of assays with EUA for the detection of SARS-CoV-2 nucleic acid from clinical specimens.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / RNA, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Diagnostic Test Approval / Betacoronavirus Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Year: 2020 Document Type: Article Affiliation country: JCM.00796-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / RNA, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Diagnostic Test Approval / Betacoronavirus Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: North America Language: English Year: 2020 Document Type: Article Affiliation country: JCM.00796-20