AUG 26, 2020 11:00 AM PDT | AUGUST 27, 11:00 AM SGT | AUGUST 27, 4:00 PM CEST

SARS-CoV-2 Quality Control for Molecular and Serology assays

Sponsored by: Bio-Rad Laboratories
C.E. Credits: P.A.C.E. CE Florida CE
  • Director, Clinical Microbiology Laboratory, Associate Director, Division of Clinical Pathology, Professor of Pathology, University of Michigan
      Duane Newton, Ph.D., D(ABMM) is currently the Director of the Clinical Microbiology Laboratory, as well as the Associate Director of the Division of Clinical Pathology, both in the Department of Pathology at Michigan Medicine.
      Dr. Newton completed Post-Doctoral training at the University of Tennessee and the VA Medical Center in Memphis, Tennessee and a Clinical and Public Health Microbiology Fellowship at the University of Rochester Medical Center, Clinical Microbiology Laboratories in Rochester, New York. In 2000 he was appointed as Manager of the Virology/Immunology Section of the Department of Community Health, Division of Infectious Diseases, Bureau of Laboratories for the State of Michigan and as Adjunct Assistant Professor for the Michigan State University Medical Technology Program. In 2002, he joined the faculty of the Department of Pathology at the University of Michigan Medical School as Clinical Assistant Professor and Associate Director of the Microbiology/Virology Laboratories.
      Dr. Newton was named Director of Microbiology/Virology Laboratories in 2003 and received his certification as a Diplomate by the American Board of Medical Microbiology in 2004.
      His research interests lie in the development of molecular assays for the diagnosis and management of infectious diseases.
    • Director, Infectious Diseases Serology Laboratory, Clinical Microbiology Division, Department of Laboratory Medicine and Pathology, the Mayo Clinic, Minnesota

        Elitza S. Theel, Ph.D., D(ABMM), is the Director of the Infectious Diseases Serology Laboratory at Mayo Clinic and an Associate Professor of Laboratory Medicine And Pathology at the Mayo Clinic College of Medicine in Rochester, Minnesota. Dr. Theel completed her Postdoctoral Fellowship in Clinical and Public Health Microbiology at the Mayo School of Graduate Medical Education after she graduated with her PhD in Medical Microbiology and Immunology from the University of Wisconsin-Madison. Her interests include development and evaluation of serologic methods, including antibody and antigen detection assays, for diagnosis of difficult to culture or otherwise identify infectious diseases. Dr. Theel has evaluated over 15 different serologic tests for detection of antibodies to SARS-CoV-2 over the past few months and has co-development a neutralizing antibody test for the virus, which is currently being used to screen potential plasma donors as part of the national COVID-19 convalescent plasma clinical trials. 


      SARS-CoV-2 has created significant challenges for laboratories, requiring the development, validation, and scale up of testing in a very short time period--often this was done for multiple methods due to capacity demands and supply chain shortages.  Part of assuring quality test results is the confidence in testing that comes from a robust QC Program.  In this webinar, the speakers will discuss different issues to be considered for QC material selection, as well as QC program design & strategies for SARS-CoV-2 molecular and serology testing.


      Learning Objectives:

      1. Describe approaches to quality control for SARS-CoV-2 molecular testing that monitor the entire testing process

      2. Discuss quality control approaches for high-throughput SARS-CoV-2 antibody tests

      3. List 2 optimal QC practices for each methodology

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