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SEP 17, 2020 3:30 PM PDT

SARS-CoV-2 Testing Today and a New Serology Approach For High Throughput Screening

Sponsored by: LGC Seracare
C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Chief Scientific Officer, LGC SeraCare
    Biography

      Russell Garlick, PhD, is the Chief Scientific Officer at LGC SeraCare Life Sciences. Since 2012 he has been focusing on expanding the company’s technologies, R&D organization, and product development pipeline. Throughout his career he has worked on the development, regulatory approval, and launch of a variety of technologies and assays, including an HIV/AIDS patient management program, molecular genomics technologies, and HIV drug discovery systems. Prior to joining LGC Clinical Diagnostics, Dr. Garlick was co-founder of Life Sciences Group and served as CEO and CTO of Protein Forest, Inc. He has also held executive R&D positions at PerkinElmer Life Sciences and DuPont NEN Life Sciences.

    • Associate Scientific Director at LGC
      Biography

        Richard is the Associate Scientific Director within the large molecule bioanalytical group at LGC, where his responsibility lies with overseeing LBA method development and validation to support ADA, PK and biomarker studies. Richard has been at LGC for 10 years, but also has had previous roles at GlaxoSmithKline and Respiratory Clinical Trials Ltd.

      • Assistant Professor of Pathology and Laboratory Medicine, Geisel School of Medicine at Dartmouth and Assistant Director, Clinical Genomics and Advanced Technology (CGAT) Laboratory
        Biography

          Joel A. Lefferts, PhD, HCLD, DABCC is an assistant professor of Pathology and Laboratory Medicine at the Geisel School of Medicine at Dartmouth and Assistant Director of the Clinical Genomics and Advanced Technology (CGAT) Laboratory at the Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, New Hampshire and also serves as a medical director of the clinical laboratory at Valley Regional Hospital in Claremont, NH. Within the CGAT Laboratory, he leads the chromosome microarray and molecular infectious disease services, is responsible for evaluating new platforms and validating new clinical tests for infectious disease, oncology and genetic applications. He also is active in the laboratory’s next generation sequencing efforts, serves as IRB chair at DHMC, and is the director of the lab’s Molecular Diagnostics Fellowship program.


        Abstract

        Russell Garlick:

        SARS-CoV-2 Reference Materials for Assay Validation and QC

        LGC SeraCare develops and manufactures a comprehensive portfolio of SARS-CoV-2 catalog and custom-developed diagnostic controls, standards and reference materials for IVD assay developers, clinical labs and CROs. This presentation will focus on the products and technologies being used today to help validate and QC SARS-CoV-2 RNA testing and SARS-CoV-2 serological testing.

        Joel A Lefferts:

        Making Qualitative SARS-CoV-2 RNA Tests Quantitative

        The current SARS-CoV-2 pandemic has had a dramatic impact on healthcare and more specifically, laboratory medicine. Clinical laboratories across the country are meeting the new challenges that continue to emerge from month to month such as uncertain reagent supply issues, need for new technologists, increased needs for instrument servicing, and adding staff to work additional shifts. Many laboratories are even facing supply chain issues with even the most basic items such as PPE or pipette tips. As laboratories continue to perform high volumes of SARS-CoV-2 testing a common trend in clinical, development, and research testing is the growing need for tests that can produce quantitative results. Quantitative SARS-CoV-2 test results are valuable for test validation, quality improvement, and a better understanding of the biology of the virus and its effects on those who become infected.

        Learning Objectives:

        1. Understand the challenges facing clinical laboratories performing or planning to perform diagnostic SARS-CoV-2 RNA testing

        2. List reasons why quantitative SARS-CoV-2 results may be valuable to clinical and research laboratories

        Richard Hughes:

        New Immunogenicity Strategies to Meet the Needs of a Developing Pandemic

        Shortly after the COVID-19 pandemic began, the subject of serological testing for anti-viral antibodies became common in the global news media as a key indicator of previous infection by the virus, and a potential indicator of future immunity to the disease. The analysis of unwanted immunogenicity is commonplace in bioanalytical workstreams, but what differs when you have evolving frontiers, mass testing requirements, emerging biology and a regulatory minefield? Our goal was to create an assay that could be used for both serum samples and with dried blood microsamples that enable remote sampling. In addition to validating the assay performance for both matrices, we set about verifying the assays according to recommendations and guidance from UK Government agencies and the Royal College of Pathologists. This included sensitivity and specificity assessments of the serum assay using cohorts of COVID-19 patient samples, where infection by SARS-CoV-2 was confirmed by a PCR test 21 days prior to the sample being taken, along with prepandemic era samples that included patients exposed to other coronaviruses and respiratory diseases. Additionally sample comparisons were performed with collaborating laboratories using government approved commercial assays from major IVD manufacturers. The utility of microsampling was confirmed by performing analysis on surrogate blood samples, along with paired capillary Mitra and venous samples taken simultaneously from volunteers. This presentation will further touch on the conundrums that arose on our journey when we decided to apply our standard approaches for measuring unwanted immunogenicity to the measurement of anti-SARS-CoV-2 antibodies.

        Learning Objectives:

        1. Understanding the integral value of collaboration for advancement in scientific research; how to establish and grow clinical lab, academic, Pharma, and industry connections

        2. Learn about the high-tech science technologies and techniques being used to defeat the global COVID-19 epidemic


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