Drs. Tsongalis and Fernandes will discuss the challenges of implementing Emergency Use Authorization (EUA) testing for the detection of SARS-CoV-2 RNA during the recent COVID-19 pandemic. In addition, they will focus on the implementation and clinical utility of these EUA tests for the detection of SARS-CoV-2 RNA at laboratories in the epicenter of the COVID-19 pandemic.
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- Discuss key challenges in implementing EUA assays for SARS-CoV-2, especially the issues faced at the preanalytical and analytical level of assay implementation
- Understand the pros and cons of EUA assays
- Explain acute strategic planning strategies utilized during the pandemic
- Discuss the impact of symptomatic versus asymptomatic patient testing on the laboratory
- Examine the overall impact of molecular testing for monitoring the pandemic
Gregory J. Tsongalis, PhD, HCLD is the Vice Chair for Research and Director of the Laboratory for Clinical Genomics and Advanced Technology (CGAT) at the Dartmouth Hitchcock Medical Center in Lebanon, NH and Professor of Pathology and Laboratory Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH.
Helen Fernandes, PhD is a director in the Personalized Genomic Medicine Laboratory at Columbia University Irving Medical Center in NYC. She is actively involved in the practice, education, and promotion of molecular diagnostics and has presented at several national and international meetings.
- New York State Department of Health COVID-19 Tracker
- U.S. Food and Drug Administration Emergency Use Authorizations
- Prevention, C.o.D.C.a., Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
- Information for Laboratories about Coronavirus (COVID-19)
- Understanding, verifying and implementing Emergency Use Authorization molecular diagnostics for the detection of SARS-CoV-2 RNA
- Implementation of an Emergency Use Authorization Test During an Impending National Crisis