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Testing for SARS-CoV-2: The Cleveland Clinic Experience

C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Medical Director & Co-Chair, Enterprise Laboratory Stewardship Committee, Enterprise Medical Operations, & Director of Microbiology, Virology, Mycology & Parasitology, Clevelaland Clinic
    Biography
      Gary W. Procop, MD, MS is Medical Director and Co-Chair of the Enterprise Laboratory Stewardship Committee for Enterprise Medical Operations. He is the Director of Molecular Microbiology, Virology, Mycology and Parasitology at the Cleveland Clinic. He is past Chair of the Departments of Clinical Pathology and Molecular Pathology, and past Section Head for Clinical and Molecular Microbiology. He completed a Bachelor of Science at Eastern Michigan University, followed by an M.D. and M.S. at Marshall University School of Medicine. Residency training in Anatomic and Clinical Pathology training was completed at Duke University Medical Center and a Clinical Microbiology Fellowship at the Mayo Clinic. He is a diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, and Medical Microbiology. He is a Fellow of the American Academy of Microbiology, the College of American Pathologists, the American Society for Clinical Pathology, the Infectious Diseases Society of America, and the Royal Society of Tropical Medicine and Hygiene. He has given more than 670 scientific presentations, and has 218 published manuscripts, 50 chapters, and three books to his credit. He is the former Chair of the Committee on Continuing Certification (3C), member of the Accountability & Resolution Committee, and a Member of the Board of Directors of the American Board of Medical Specialties. He is a former Chair of the Microbiology Test Development Committee, a Past President, former Trustee and is currently an ex officio of the American Board of Pathology. He is Member of the Board of Directors and the Chair of the Antifungal Subcommittee of the Clinical Laboratory Standards Institute. He is a member of the Board of Directors of the American Society for Clinical Pathology, the Chair of the Commission on Science, Technology and Policy, and a Member of the Effective Test Utilization Subcommittee of this Commission. He is also a former Member of the Council on Scientific Affairs, former Chair of the Microbiology Resource Committee and is a current member of the Quality Practices Committee for the College of American Pathologists. He has served as a Member of the NGS Coalition and Conferences Committee for the American Society for Microbiology. Major recognitions include the ASM BD Award for Research in Clinical Microbiology, the CAP Distinguished Patient Care Award, the Cleveland Clinic John Beach Hazard Teaching Award, the ASCP Mastership Designation, and the Belinda Yen-Lieberman, PhD, and James M. Lieberman, MD, Endowed Chair in Clinical Microbiology. His primary interests are developing and promoting best practices in laboratory testing, the practical applications of molecular diagnostic methods for the diagnosis and treatment of infections; infectious disease pathology; mycology and parasitology. He is currently working on a Masters of Education in Health Professions through Johns Hopkins University.

    Abstract

    This presentation will discuss the use of the FDA EUA process to implement SARS-CoV-2 assays to address the COVID-19 pandemic.  The use of a team-based approach, through an Incident Command structure, to optimally address all the operational challenges in validating, implementing and maintaining SARS-CoV-2 testing for the patient population in a large tertiary care referral center.  The presentation we review a comparison of five SARS-CoV-2 assays.   Evaluation of the changes in viral load thoughout the time course of COVID-19 infections will be reviewed, and how this related back to the five test comparison will be discussed.  The importance of the population tested (i.e. high versus low prevalence) will be reviewed, as diagnostic tests are being used as screening tests.  The presentation will review the testing of saliva as an alternate diagnostic specimen, and will explain the benefits and limitations of pool testing of diagnostic specimens.  In conclusion, the presentation will describe how testing is integrated with mitigation strategies necessary to curtail the COVID-19 pandemic.

    Learning Objectives:

    1. Describe the optimal uses for the various types of SARS-CoV-2 tests (i.e. antigen, antibody, & different nucleic acid amplification assays)

    2. Discuss the molecular detection of SARS-CoV-2 during COVID-19 convalescence

    3. Discuss the impact of utilizing a test with high (95%) specificity in a diagnostic setting versus screening setting

    4. Review the benefits and limitations of testing alternate specimen types (e.g. saliva) and utilizing alternate testing strategies (e.g. pooling) for the detection of SARS-CoV-2


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