23rd SCIENTIFIC WORKING GROUP ON THE STANDARDISATION OF GENOME AMPLIFICATION TECHNIQUES FOR THE SAFETY TESTING OF BLOOD, TISSUES AND ORGANS FOR BLOOD BORNE PATHOGENS SoGAT Blood Virology Meeting Vilnius, Lithuania - 16-17 April 2012 AGENDA Each speaker will be allocated 10-15 minutes for each presentation including 2-3 minutes for questions. Speakers are requested to keep the presentation concise and not to include too much background information. Approximately 30 minutes is set aside at the end of each session to allow for further discussion of issues which are relevant to that session. DAY 1 MONDAY 16 APRIL 2012 07:45-08:30 Registration 08:30-08:40 Welcome Address Introduction: Stephen Inglis, Director, NIBSC, UK Welcome Address: Saulius Caplinskas, Director, Centre for Communicable Diseases, Lithuania 08:40-09:00 SESSION 1 Overview of blood virology testing in the Baltic States Saulius Caplinskas, Centre for Communicable Diseases, Lithuania 09:00-11:00 SESSION 2 - International Standard Development Chair: Clare Morris Overview on the development of WHO International Standards Philip Minor, NIBSC, UK Development of the 2nd HIV Genotype Panel Clare Morris, NIBSC, UK Development of a Dengue Virus Reference Panel Maria Rios, CBER, USA Update on the 1st Chikungunya Virus RNA Reference Panel Maria Rios, CBER, USA Update on West Nile Reference Reagents Maria Rios, CBER, USA Progress update on the development of a Hepatitis D virus International Standard Micha Nuebling, PEI, Germany Round Table Discussion 11:00-11:30 Tea/Coffee Break Page 1 of 3 11:30-12:30 SESSION 3 - Problems Occurring with Genotype Detection, (part I) Chair: Neil Berry Overview of deep sequencing technology to identify viral variants, experiences of sequencing genotypes Neil Berry, NIBSC, UK Novel generic method for developing Quantitative NAT Assays Speaker TBA, Roche, USA Update on the HIV Variants Panel Indira Hewlett, CBER, USA 12:30-14:00 Lunch (possible SOGAT Committee Meeting) 14:00-15:00 SESSION 3 - Problems Occurring with Genotype Detection, (part II) Chair: Neil Berry HCV Genotype experience from a panel manufacturer Pat Garrett, SeraCare, USA Correlation between HBV infectivity and detection of HBV genome variants Jean-Pierre Allain, University of Cambridge, UK Development of an HEV genotype panel Micha Neubling, PEI, Germany Pilot study results of Global NIH HIV Variants Study Mark Manak, MHRP, USA General Questions from Session 3 15:00-15:30 Tea/Coffee Break 15:30-17:30 SESSION 4 - External Quality Assurance Scheme Panels Chair: Karen Cristiano EQA Programme for WNV: The Italian experience Karen Cristiano, ISS, Italy ISS EQA panel for Tri NAT (HCV, HIV and HBV) Karen Cristiano, ISS, Italy Genotype issues with EQA Panels Vivienne James, HPA, UK EDQM HIV, HCV and B19 NAT PTS studies in 2011 Marie-Laure Hecquet, EDQM, France NRL EQAS for Donor Screening Giuseppe Vincini, National Reference Laboratory, Australia HCV genotyping, experiences from INSTAND EQA Heinz Zeichhardt, National Reference Centre for HCV, Germany Round Table Discussion of Sessions 3 and 4 17:30 END OF DAY 1 Page 2 of 3 DAY 2 TUESDAY 17 APRIL 2012 08:30-10:30 SESSION 5 - Overview of Issues Surrounding Established Standards Chair: Philip Minor Overview of the use of Biological Standards John Saldanha, Roche, USA Development of a nucleic acid standard based on SI units Marcia Holden, NIST, USA Commutability - Report back from WHO meeting to be held February 2012 Philip Minor, NIBSC, UK Stability of 4th HCV IS - Is a 5th required? Philip Minor, NIBSC, UK Stoppered vial integrity Clare Morris, NIBSC, UK 10:30-11:00 Tea/Coffee Break 11:00-12:45 SESSION 6 - Regulatory Issues Chair: Micha Nuebling NAT implementation guidelines: Time for an update? Albrect Groner, CSL Bering, Germany Update of NAT screening policy in the US Indira Hewlett, CBER, USA Update on NAT screening policy in Europe Micha Neubling, PEI, Germany Update on Japanese guidelines for NAT Yoshiaki Okada, National Institute of Infectious Diseases, Japan Round Table Discussion 12:45-13:15 SESSION 7 - Summing Up Key elements discussed and forward action plan John Saldanha, Roche, USA Audience Comments 13:15 END OF WORKSHOP Page 3 of 3