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We are sponsoring and presenting at Bio-insider virtual event - Diagnostic Landscape for COVID-19
Time: Thursday, June 18, 2020,10:00am-4:30pm EST
10:00 AM
Organizer’s Opening Remarks
Emily Le, PhD, Founder & CEO, Bioinsider
10:05
Program Chairperson’s Opening Remarks
Karl V. Voelkerding, MD, Professor, Pathology, University of Utah; Medical Director for Genomics and Bioinformatics, ARUP Laboratories
10:10
Comparing Diagnostic Methods for COVID-19: Practical and Statistical Considerations
Timothy J. O' Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs
Performance comparisons among diagnostic tests require attention to timing, ease, and appropriateness of use, sensitivity, and specificity. The talk will address points to consider when evaluating literature making such comparisons, as well as practical and statistical considerations that should inform diagnostic device comparisons.
10:35
Multiplatform Comparisons of Molecular Tests for COVID-19: Predicting Differences in Case Detection
David Hillyard, MD, Medical Director, Molecular Infectious Diseases; Professor, University of Utah School of Medicine
This talk will summarize current methods used to determine the analytic sensitivity of EUA approved COVID-19 tests and approaches to determine the impact of test sensitivity on case detection.
10:55
The Critical Role of Antigens in COVID-19 Serological Test Development
Teng Peng, PhD, Technical Application Manager, ACROBiosystems
High-quality recombinant SARS-CoV-2 antigens play an essential role for the development of antibody test kits. The selection of construct and expression host cell are key determinants in producing antigen proteins with high bioactivity and batch-to-batch consistency. Optimization of constructs and screening of expression host cell can lead to suitable antigens for serological test development.
11:05
Speed Networking
11:25
Session Break
11:35
Development, Implementation, and Regulation of Diagnostic Methods at the State Level – New York Perspective
Kirsten St. George, PhD, Director, Virology Laboratory; Chief, Viral Diseases, Wadsworth Center; Clinical Professor, School of Public Health, Biomedical Sciences, SUNY
From the earliest days of diagnostic testing and initial emergency use authorizations, through current day challenges of large-scale screening of health care personnel and patients, the COVID-19 pandemic has presented unprecedented challenges to all laboratories. This presentation will provide an overview of experiences at the New York state public health laboratory including diagnostic, regulatory, and research response efforts.
12:00 PM
Development and Scaling of the LabCorp COVID-19 RT-PCR Test
Brian Krueger, Associate Vice President, Technical Director, R&D at LabCorp
LabCorp was the first commercial diagnostics company to receive emergency use authorization for COVID-19 RT-PCR testing and at-home collection of COVID-19 samples. Development began in late January and culminated with the at-home collection approval on April 20, 2020. LabCorp has since scaled its PCR testing operation to over 100,000 samples per day with a turnaround time of 1-2 days.
12:25
Speed Networking
12:45
Session Break
1:30
The Rapidly Evolving Role of Antibody Testing for SARS CoV-2
Co-presenter: Patricia Slev, D(ABCC), Section Chief Immunology Division, Medical Director Core Immunology; Medical Director Microbial Immunology, Medical Director Serologic Hepatitis and Retrovirus Laboratory; Associate Professor, Pathology, University of Utah
Co-presenter: Elitza Theel, PhD, Associate Professor, Laboratory Medicine, and Pathology, Mayo Clinics
Serology testing for SARS CoV-2 is now available on a number of platforms and more are receiving approval each day. This presentation will provide an overview of the current assays, including appropriate use of the different methodologies for antibody testing, clinical utility, and result interpretation.
What We Know About Serology Testing - An Interview with Dr. Patricia Slev
1:55
Interpretation of COVID-19 Diagnostic Test Results: A Clinician' s Perspective
Ralph Rogers, MD, Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University
The rapidly expanding number of diverse SARS-CoV-2 molecular and serologic tests now available to clinician’s paired with the disparate performance characteristics of various assays may lead to challenges when interpreting test results. This case-based presentation will explore the limitations of currently available diagnostics in various clinical scenarios, and will highlight important factors to consider when ordering and interpreting these tests.
2:20 Session Break
2:30
Home Collection of Nasal Specimens – Lowering the Barrier to SARS-CoV-2 Testing and Expanding Access to Care
Karen A. Heichman, PhD, Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation
Diagnostic testing for SARS-CoV-2 remains a challenge today, even after several weeks and with the emergence of a number of innovations. In the first weeks of the epidemic in the US, it became clear that even specimen collection was severely limited by shortages in NP swabs, viral transport media, medical personnel to collect specimens and PPE to prevent the exposure of healthcare works while collecting specimens. The knowledge that a simple nasal swab made of spun polyester, which may be manufactured inexpensively and at high capacity, together with the finding that a swab may be stably stored and transported to the lab for testing in a dry tube, without cold chain, has lowered the barrier to specimen collection and is enabling for self-collection in the home or workplace. We believe that a pre-positioned home collection kit, comprised of a polyester nasal swab, a simple tube and collection instructions, could dramatically broaden the access to SARS-CoV-2 testing in both the developed world as well as in low and middle income countries.
2:45
Closing Panel Discussion: Considerations for All Tests and How to Properly Handle the Pandemic with the Current Testing Capacity
Moderator: Karl V. Voelkerding, MD, Professor, Pathology, University of Utah; Medical Director for Genomics and Bioinformatics, ARUP Laboratories
Panelists: Karen A. Heichman, PhD, Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation
Yuan-Po Tu, DVM, MD, Urgent Care Physician, Medical Director, Flu Services, Anticoagulation, Epic Provider Efficiency, The Everett Clinic-Part of Optum
Ralph Rogers, MD, Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University
Brian Krueger, Associate Vice President, Technical Director, R&D at LabCorp
Timothy J. O’Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs
3:15
End of Main Event and Transition to Breakout Discussion
3:30 - 4:30
Breakout Discussion
Join our 1-hour breakout discussions for face time with our speakers and your peers. These are informal, moderated discussions featuring brainstorming and interactive problem solving—allowing participants from diverse backgrounds to exchange ideas and experiences, and develop future collaborations around a focused topic. In order to ensure effective discussion, breakout discussions will have a maximum of 10-15 attendees per room and are on a first-come, first-served basis.
* Separate registration required and space is limited. To register, click here.
Breakout Room 1: Translational Diagnostic Pipelines: Pre-clinical and Clinical Best Practices
Moderator: John Sninsky, Consultant, Translational Sciences
Balancing diagnostic, therapeutic and vaccine development
Best practices and key regulatory guidance for translational diagnostics
Comparative diagnostic performance metrics
Breakout Room 2: Biomarkers to Predict Severe COVID-19
Moderator: Sam Ali, PhD, Strategic Partnerships and Ventures at Denka Corporation
Why do some patients exhibit severe disease manifestation?
Discovering predictive severity biomarkers
Strategies for applying mass screening for predicting severe COVID-19 patient
Breakout Room 3: What We Know About Serology Testing
Moderator: Patricia Slev, D(ABCC), Section Chief Immunology Division, Medical Director Core Immunology; Medical Director Microbial Immunology, Medical Director Serologic Hepatitis and Retrovirus Laboratory; Associate Professor, Pathology, University of Utah
Best practices for serology testing
Serology testing applications
The science behind antibody testing
Breakout Room 4: Ongoing Challenges with COVID-19 Diagnostics
Moderator: Kirsten St. George, PhD, Director, Virology Laboratory; Chief, Viral Diseases, Wadsworth Center; Clinical Professor, School of Public Health, Biomedical Sciences, SUNY
What is the situation with antigen testing?
Do we still need more molecular assays or platforms?
Is there any role for culture and does it really need BSL-3?
The elephant in the room – the authorization of tests
Breakout Room 5: Rapid Testing
Moderator: Timothy J. O’Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland
School of Medicine; Former Chief Research and Development Officer, Veterans Affairs
How do we most effectively use rapid diagnostic tests, such as ID NOW and Xpert/Xpress, in the emergency room setting?
Is there a role for rapid diagnostic testing in surveillance of Covid19-facing healthcare personnel?
What, if any, is the best way to use lateral flow serologic testing in dealing with the Covid-19 pandemic.
Breakout Room 6: Clinical Considerations When Testing for SARS-CoV-2
Moderator: Yuan-Po Tu, DVM, MD, Urgent Care Physician, Medical Director, Flu Services, Anticoagulation, Epic Provider Efficiency, The Everett Clinic-Part of Optum
Timing and selection of SARS-CoV-2 tests
Optimizing specimen collection for diagnostic testing
Alternative options when facing swab and transport media shortages
4:30
End of Diagnostic Landscape for COVID-19
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