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Research Microbiologist-Team Lead
Centers for Disease Control and Prevention Atlanta, GA

Sr. Director of R&D, Thermo Fisher Scientific

Establishing and evaluating proper controls are critical to the success and accuracy of any diagnostic assay. Successful controls increase confidence in a diagnosis by verifying that every step in the diagnostic process is working properly and providing reliable information. The testing volume and supply shortages incurred due to the COVID-19 pandemic have stressed all aspects of respiratory disease diagnosis, heightening the importance of internal and external controls.

Dr. John R. Barnes from the Centers for Disease Control and Prevention will give a  presentation focusing on developing and validating internal and external controls for nucleic-acid based tests for infectious respiratory disease, using the new CDC Influenza SARS-CoV2 Multiplex Assay as an example. The possible effects of shortages and processing changes on diagnosis and the importance of evaluating controls during the COVID-19 pandemic are also discussed.

Tony Prestigiacomo, Sr. Director of R&D at Thermo Fisher Scientific, will then talk about the importance of quality control in serological testing for infectious disease.

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1:00 pm2020
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Demystifying COVID-19 Antibody Testing


Professor and Medical Director of Clinical Chemistry,
University of Chicago

Infectious Disease Fellow,
University of California, San Diego

Antibody testing is expected to play an important role in the management of the COVID-19 pandemic. With the cluttered landscape of both lab-based and lateral flow serology testing options, it has become challenging to know which way to lean, and where the cross section of accuracy and access lie. 

In this webinar, Dr. Jerry Yeo, Professor and Medical Director of Clinical Chemistry at University of Chicago, and Dr. Stephen Rawlings, Infectious Disease Fellow at University of California, San Diego, will summarize their thoughts on the value, utility and limitations of antibody tests for SARS-CoV-2.  

They will review how rapid lateral flow serology tests work and considerations when choosing a test. They will also share data from their independent studies focused on assessing the performance of lateral flow tests, including a comparison to a standard laboratory serology instrument.

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Postdoctoral Research Fellow,
University of Notre Dame

Environmental Scientist,
Hampton Roads Sanitation District

As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity. Traditionally such efforts have relied solely on clinical testing of individual patients. But recent reports demonstrate that a proportion of the individuals infected with SARS-CoV-2, the virus responsible for COVID-19, shed viral RNA into feces providing the opportunity to surveil wastewater to monitor the presence and trends of SARS-CoV-2 infection within a community. This practice, known as wastewater-based epidemiology (WBE), has been previously used to monitor public health status for a number of viruses including poliovirus, norovirus, hepatitis A, hepatitis E, and aichi virus.  Importantly, initial studies indicate that SARS-CoV-2 RNA shedding in feces is agnostic to symptom severity, which indicates WBE could provide less biased public health monitoring than clinical testing alone. 

In this webinar, Aaron Bivins of the University of Notre Dame will describe methods for direct-adsorption extraction and Droplet Digital PCR (ddPCR) for the sensitive and reproducible quantification of SARS-CoV-2 RNA in primary influent samples from two municipalities.  

Raul Gonzalez of Hampton Roads Sanitation District will provide insights on a 20-week study demonstrating that wastewater SARS-CoV-2 concentrations have steadily risen ahead of clinically confirmed cases and propose several ways that data can be presented to be of greatest use to public health officials. 

Together they will highlight the utility of wastewater-based epidemiology to detect and track SARS-CoV-2 infection within a community using Droplet Digital PCR. 

Vice President, Scientific Affairs, SpeeDx

Senior Field Application Scientist, UgenTec

Business Development Manager, Latin America, Thermo Fisher Scientific

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Data analysis software has become an integral component of in vitro diagnostic assays in general, and molecular diagnostic tests in particular. The ability to provide a software solution for end users that accurately reports results, identifies technical issues, and can be integrated with a laboratory’s information systems can be as important in the final decision about whether to adopt a given platform as analytical and clinical performance data.

Another important consideration for molecular diagnostic development is the decision whether to develop a novel instrument or to leverage a third-party open platform. Considerations not only include size or price, but also the global installed base, available service plans, options for instrument placement and reagent rental. These choices impact capital efficiency, time to commercialization, and accelerated adoption of the assay in the market. 

SpeeDx is a developer of innovative multiplexed molecular diagnostic assays that employ a novel PCR technology (PlexZyme). Although the assay chemistry is flexible and instrument agnostic, the company needed a customizable software application that could take unique data feeds from different instruments and turn them into accurate reportable results with minimal involvement from end users.

This presentation will discuss the partnership between SpeeDx and Ugentec to produce an integrated data analysis solution for SpeeDx customers running the assay on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument , covering the key elements of the Ugentec software. 

After the main presentation, UgenTec will briefly discuss its FastFinder software platform that allows labs and assay providers to build sample-to-result workflows and Thermo Fisher Scientific will briefly introduce its instrumentation, reagent, and services portfolio for assay development. The presentations will be followed by an interactive Q&A session with attendees.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections. The agency's policies for granting EUAs for both molecular and antibody tests evolved over time as more was learned about SARS-CoV-2 and its spread, and diagnostics firms and labs needed to adapt to these changes.

Dr. Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the FDA's Center for Devices and Radiological Health, will kick off this virtual roundtable with an overview of the EUA program, how it evolved, and how lessons learned during the current pandemic may shape future policies and actions by the FDA. She will then take part in a panel discussion that will include a variety of stakeholders from the diagnostics and clinical lab industries. Panelists will include Dr. Robert Boorstein, Medical Director of Lenco Diagnostic Laboratories; Danelle Miller, VP, Global Regulatory Policy and Intelligence for Roche Diagnostics; Dr. Jeffrey Klausner, Professor of Medicine and Public Health at UCLA David Geffen School of Medicine and Fielding School of Public Health; and Gail Javitt, Director at Hyman, Phelps & McNamara.

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