SARS CoV2 Workshop

Medicines & Healthcare products Regulatory Agency

SARS CoV2 Workshop held by The National Institute of Biological Standards and Control  (NIBSC).

Registration has now closed. This workshop will provide a forum for molecular diagnostic laboratories, regulators, manufacturers and other stakeholders to discuss the challenges faced during the COVID-19 pandemic. With the rapid development of assays, we look at the challenges faced with detection and quantification of SARS-CoV-2 using new molecular techniques and understand the assurances needed for rolling out these assays to settings beyond the professional diagnostic laboratory. We will discuss how external quality assurance scheme material has kept pace to provide an international snap shot of events and describe the reference materials now available to support better measurement of the analytical performance of these assays.

<h3>Programme and timings </h3><h3>Day 1 - Thursday 10 June 12:00-16:00 (BST)</h3>12:00 Welcome and introduction - Neil Almond, SoGAT Chair Session 1: 12:00-13:45 - Understanding the challenges Chair: Bert Niesters12:05 Evolution of SARS CoV molecular detection Maria Zambon, PHE, UK12:25 The Abbott Global Surveillance Program: SARS-CoV-2 variant vigilance Mary Rodgers Abbott, USA12:45 Validation of SARS-CoV-2 molecular assays - the WHO 'Emergency Use Listing' experience Ute Ströher, WHO, Switzerland13:05 Evaluation of NAT and Ag testing devices Wayne Dimech, NRL, Australia13:25 Evaluation of SARS-CoV-2 IVD in the EUMicha Nübling, PEI, Germany13:45 BreakSession 2: 14:00-16:00 - Developing reference materials Chair: Roberta Madej 14:00 Molecular detection of SARS-CoV-2 EQA- Can Ct values be used as an indicator of the viral load?Sanjiv Rughooputh, NEQAS, UK14:20 Molecular INSTAND EQA schemes for SARS-CoV-2 detection and a study with National Reference Materials for linking Ct values with SARS-CoV-2 RNA loads”. Heinz Zeichhardt/Martin Kammel, INSTAND, Germany14:40 External Quality Assessment (EQA) for SARS-CoV-2 Molecular Detection – Experiences from 2020Oliver Donoso, QCMD, UK14:55 Round table discussion session Chairs: NIBSC Lessons learned – future pandemics, how can we do things betterHow can EQA data be used to improve assays?15:55 Close <h3>Day 2 - Friday 11 June 12:00-16:00 (BST)</h3>12:00 Welcome and introduction - Neil Almond, SoGAT Chair Session 3: 12:00-14:00 - dPCR and NGS methods to detect covid19 Chair: Neil Berry 12:05 The CCQM Nucleic Acid Working Group (NAWG) and its response to SARS-CoV-2Jim Huggett, Chair of the NAWG12:20 Strategy of the whole genome SARS-CoV-2 Certified Reference Material from the National Measurement Institute, AustraliaDaniel Burke, NMIA, Australia12:35 Digital PCR Measurements of SARS-CoV-2: Lessons Learned (So Far…)Peter Vallone, NIST, USA12:50 The impact of targeting different regions of the SARS-CoV-2 genome on the measured quantityDenise O’Sullivan, NML at LGC, UK13:05 Using NGS to identify SARS CoV2 variants Dr Charles Chiu, University of California.13:25 Round table discussion session 3 - Chairs: NIBSC<ul><li>How can we best use NGS data to understand viral evolution?</li><li>How can qPCR and dPCR work together?</li></ul>14:00 BreakSession 4: 14:15-16:00 - Development of reference materials Chair: Micha Nübling 14:15 Overview of challenges faced when developing reference materials for SARS CoV2NIBSC14:30 Development of a WHO SARS CoV2 NAT International StandardGiada Mattiuzzo, NIBSC, UK14:50 SARS CoV2 Antigen detection, not all controls are suitableJacqueline Fryer, NIBSC, UK15:10 Calibration of secondary SARS CoV2 reference materialJohn Sninsky, USA 15:30 Round table discussion session 4 - Chairs: NIBSC<ul><li>What other reference materials are needed?</li><li>Challenges of clinical relevance vs analytic sensitivity</li></ul>16:00 Close Please note programme and timings are subject to change.

<h3>Frequently Asked Questions</h3>When will I receive details of how to join the meeting? Joining instructions with the meeting link will be issued at least 48 hours ahead of the meeting. Get in touch: If you have any further questions and/or comments please do get in touch by sending an email to: sogat@nibsc.orgAccess requirements:If you have any access requirements that we may address to make your participation at our events more enjoyable, please do let us know when registering.

<h3>Data Protection</h3>The Medicines and Healthcare products Regulatory Agency will use the information you have provided via the third-party data processor Eventbrite, to facilitate the event, provide you with an acceptable level of service. Any access requirements will be processed internally and will not be shared in any identifiable way with the venue. We will contact you using the information provided for the purpose of this event. By providing the information you agree to the data being processed and stored as outlined.Privacy NoticesThe National Institute for Biological Standards and Control (NIBSC) has its own privacy notice which outlines how we collect and use personal data in accordance with the Data Protection Act 2018 and the General Data Protection Regulation (GDPR) 2016/679.To find out how we use and manage your personal data please visit the <a href="https://nibsc.org/about_us/privacy_notice.aspx" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">NIBSC Privacy Notice.</a>

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SARS CoV2 Workshop

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