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22nd SoGAT Meeting

SoGAT XXII Presentations

 

Welcome address:

 Dr. Carlo Pini, Director of the National Centre for Immunobiologicals Research and Evaluation (CRIVIB) of the ISS. 

 

Session 1

Speaker

Title of presentation

Clare Morris, NIBSC, UK

Development of 3rd HIV-1 International Standard

 

Jacqueline Fryer, NIBSC, UK

Replacement of the 3rd International Standard for Hepatitis C Virus

 

Jacqueline Fryer, NIBSC, UK

Replacement of the 2nd International Standard for Hepatitis B Virus, and Proposals to Replace the 1st International Standard for Hepatitis A Virus

 

Clare Morris, NIBSC, UK

Replacement of the 1st HIV WHO International Genotype panel

 

Michael Chudy, PEI, Germany

 

Development of an HEV International Standard

 

 

Session 2

Michael Chudy, PEI, Germany

Progress with an HBV DNA subtype panel

 

Mei-ying Yu, CBER, FDA, USA

WHO B19 genotype panel

 

Neil Berry, NIBSC, UK

Indira Hewlett, CBER, FDA, USA

Progress with HIV-1 genotype panels

 

Clare Morris, NIBSC

Development of new NAT reagents

 

Harry van Drimmelen, Biologicals Quality Control, The Netherlands

Quantification of HBV, HCV genotype and HIV subtype panels in nucleic acid copies/ml for evaluating changes in primer and probe design of triplex NAT assays

 

 

Session 3

Anneline Rossouw, Health Protection Agency, UK

An update on EQA schemes from UK NEQAS for Microbiology.

 

Professor Hubert Niesters, University Medical Center, Groningen, The Netherlands

The use of QCMD proficiency testing panels in clinical virology.

 

Yi Chen Yang, Food and Drug Administration, Taiwan

Collaborative study to establish the 1st National Standard for HIV-1 RNA NAT assays.

 

Giulio Pisani, ISS, Italy

EQA Programmes for blood-Bourne viruses: The Italian experience.

 

Marie Laure Hecquet, EDQM

Proficiency testing to evaluate blood transfusion laboratories performance for the detection of different genotypes of HCV.

 

 

 

Session 4

Indira Hewlett,

Mei-ying Yu, CBER, FDA, USA

Update on FDA guidance on HBV, HCV, HIV-1, WNV and B19.

 

Marie-Laure Hecquet, EDQM

EDQM Guidelines on the Validation of NAT Testing for HCV & B19 in Plasma Pools

 

Lutz Pichl, DRK-Blutspendedienst West gGmbH, Germany.

Two blood donors missed by HIV-1 NAT screening tests

 

Micha Nuebling, PEI, Germany

Cases of HIV-1 RNA non-detection and their potential impact on NAT design.  

 

 

Session 5

Neil Berry, NIBSC, UK

Overview of XMRV

 

Indira Hewlett, FDA, USA

Update on XMRV situation in America

 

Giuliano Grazzini, National Blood Centre, Italy.

West Nile Virus and blood safety: European overview with a special focus on the Italian situation.

 

 

Session 6

Albrecht Gröner, CSL Behring, Germany

NAT Assays When to Test Plasma for Fractionation

NAT Assays -some issues

John Saldanha, Roche, USA

Overview - issues with replacement International Standards

 

 

John Saldanha, Roche, USA

Calibration using International Standards and regulatory requirements concerning precision and accuracy of tests. 

 

Nico Lelie, Lelie Research, France

Commutability of inactivated or lyophilised virus in external quality control samples for viral nucleic acid testing.

 

Alan Heath, NIBSC, UK

Assigning units to replacement International Standards.

 

 

 

Session 7

Jacqueline Fryer, NIBSC, UK

Update on Clinical Diagnostics SOGAT