Update on the. Clinical Diagnostics. and. Blood Testing. Meetings of SoGAT. Micha Nübling, PEI.

Transcription

1 Update on the Clinical Diagnostics and Blood Testing Meetings of SoGAT Micha Nübling, PEI

2 SoGAT Since 1995: 22 SoGAT meetings (organized by NIBSC) 1-2 meetings/year (connected with IPFA workshop) Standardization of NAT methods for blood testing WHO ISs (HCV, HIV-1, HBV, B19, HAV, HIV-2) 2010: Decision to disconnect SoGAT and IPFA/PEI 2011, April 14-15, Rome: SoGAT XXII

3 SoGAT Since 2009: 3 SoGAT Clinical Virology meetings (organized by NIBSC) 1 meeting/year (connected with ESCV meetings) Standardization of NAT methods for clinical virology 2011, Jan 13-14, SoGAT CV III (London)

4 SoGAT Clin Virol 2011, Jan 13-14, SoGAT CV III (London) ~110 participants representing: Clinical laboratories (mainly Europe and North America) IVD manufacturers EQA providers / reference and research laboratories Control / regulatory authorities Blood transfusion centres / product manufacturers

5 SoGAT Clin Virol Session 1 Assessing assay variability through EQAS / Proficiency Testing / Data reporting NRL EQAS for NAT Giuseppe Vincini, Australia UK EQAS for EBV DNA Brigitte Senechal, UK Influenza virus detection and typing Catherine Thompson, UK EQAS in Europe William G Mackay, UK

6 SoGAT Clin Virol Session 2 Development, use and calibration of secondary reference reagents Clinical diagnostic working reagents Anna Gottlieb, UK Clinical Virology Network (CVN) Peter Simmonds, UK

7 SoGAT Clin Virol Session 3 Development and use of higher order reference materials for clinical pathogens 1st WHO IS CMV-DNA Jacqueline Fryer, UK Proposed 1st WHO IS EBV-DNA Jacqueline Fryer, UK Development WHO IS HDV-RNA Michael Chudy, Germany Development WHO IS Mycoplasma Micha Nübling, Germany Development WHO ISs HHV-6, Adenov. Jacqueline Fryer, UK Aspergillus Standard Angela Caliendo, USA Universal controls for real-time PCR Rob Schuurman, NL Internal control from a pumpkin gene George Schneider, USA Internal controls in clinical PCRs Ken Mutton, UK

8 SoGAT Clin Virol Session 4 Technical aspects of molecular assays relating to standardisation Quantification of Respiratory Viruses Christine C. Ginocchio, USA Nucleic acid isolation methods Nick Parham, UK Multiplex PCR Rory Gunson, UK

9 SoGAT Clin Virol Session 5 Regulatory issues in-house IVDs in Australia Robyn Wood, Australia IVD regulation in Australia Giuseppe Vincini, Australia FDA regulation of LDTs and POCT F. Martinez-Murillo, USA Revision to the IVD Directive Micha Nübling, Germany

10 SoGAT Clin Virol Need for standardisation for many pathogens Prioritization Selection of strains Commutability Accepted among clinical virologists as open standardisation forum No overlap with SoGAT BV Good attendance

11 SoGAT Blood Virology 2011, April 14-15, SoGAT XXII (Rome) ~80 participants representing: Screening laboratories IVD manufacturers EQA providers / reference and research laboratories Control / regulatory authorities

12 SoGAT Blood Virology Session 1 Review of standards being submitted to ECBS 2011/ new proposals 3 rd WHO IS HIV-1 RNA Clare Morris, NIBSC, UK 4 th WHO IS HCV-RNA Jacqueline Fryer, NIBSC, UK 3 rd WHO IS HBV-DNA Jacqueline Fryer, NIBSC, UK 2 nd WHO IS HAV-RNA Jacqueline Fryer, NIBSC, UK 2 nd WHO I GT Panel HIV Clare Morris, NIBSC, UK 1 st WHO IS HEV-RNA Michael Chudy, PEI, Germany

13 SoGAT Blood Virology Session 2 Development and use of NAT reagents WHO HBV genotype panels Michael Chudy, PEI, Germany WHO B19 genotype panel Mei-ying Yu, CBER, USA HIV-1 genotype panels C. Morris/N. Berry, NIBSC, UK Indira Hewlett, CBER, USA Development of new NAT reagents Clare Morris, NIBSC, UK HBV, HCV genotype and HIV subtype panels in copies/ml H v Drimmelen, NL

14 SoGAT Blood Virology Session 3 Proficiency studies / National studies EQA schemes from UK Anneline Rossouw, UK QCMD proficiency testing in clinical virology Hubert Niesters, NL 1st Taiwan Standard for HIV-1 RNA Yi C. Yang, FDA, Taiwan EQA Programmes in Italy Giulio Pisani, ISS, Italy PTS blood program for HCV-genotypes M-L Hecquet, EDQM, F

15 SoGAT Blood Virology Session 4 Guidance for NAT testing FDA guidance on HBV, HCV, HIV-1, WNV and B19 Indira Hewlett, Mei-ying Yu, CBER, USA EDQM guidelines for B19 and HAV M-L Hecquet, EDQM, F HIV-1 NAT screening experience Lutz Pichl, D HIV-1 non-detection by monotarget NATs Micha Nuebling, PEI, D

16 SoGAT Blood Virology Session 5 Emerging/re-emerging challenges XMRV Neil Berry, NIBSC, UK Indira Hewlett, FDA, USA WNV and blood safety: Europe and Italy Giuliano Grazzini, NBC, Italy

17 SoGAT Blood Virology Session 6 Standardisation of quantitative NAT tests NAT principles Albrecht Gröner, Germany Replacement Standards John Saldanha, USA Calibration with ISs John Saldanha, USA Commutability Nico Lelie, France Unitage of replacement ISs Alan Heath, NIBSC, UK

18 SoGAT Blood Virology Work is still continuing for resolved topics Replacement standards, Continuity of International Unit Stability of reference preparation Replacement or expansion of genotype panels? Design of EQAs Bias by genotype selection? Evolving issues XMRV WNV in Europe Design of NAT assay, HIV-1 mono- / dual-target NATs SoGAT BV will be continued as stand-alone meeting