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Jean-Marc SPIESER Head Departement DBO/HC

NIBSC 2 March 2007 The European Directorate for the Quality of Medicines and Health Care issues of concern regarding the detection of B19 in blood:plasma pools. Jean-Marc SPIESER Head Departement DBO/HC

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Jean-Marc SPIESER Head Departement DBO/HC

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  1. NIBSC 2 March 2007The European Directorate for the Quality of Medicines and Health Care issues of concernregarding the detection of B19 in blood:plasma pools Jean-Marc SPIESER Head Departement DBO/HC Biological Standardisation, OMCL Network and Health Care- EDQM - Council of Europe Strasbourg

  2. EDQM/STRASBOURG organised a meeting on 9 November 2006 aimed at discussing the issues related to B19 virus detection in plasma pools EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  3. A6 andV9 are definitely classified as B19 variants • Prevalence of A6 in plasma pools is rare but observed in Europe • V9 so far not been seen in Europe and USA EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  4. current kit (Roche) does not detect A6 and V9 confirmed in PTSs organised by EDQM • there exists one kit (Artus) which correctly amplifies A6 virus DNA and most of the V9 virus DNA subtypes • efforts to optimise the kits are in progress BUT • problems of licensing prevents the use of the appropriate kit for screening of plasma pools EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  5. This issue could be seen as harming public health • Therefore the two firms concerned were encouraged to reach an agreement on the use of the performant kit • Also fostering developement of new kits is an urgent issue EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  6. WHO should establish calibrated international reference preparations and calibration panels for A6 and V9 virus types • EDQM and SOGAT are supportive and cooperative EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  7. Potential problem of refusing plasma pools by the OMCLs on the basis of A6 or V9 virus types (detection versus non detection) • Consequently issue is also being discussed by OMCLs Network who are equally eager to find a solution EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  8. PTS 092 on B19 organised in 2007 will include in addition to the usual anonymised samples 4 specific - not blinded - samples with plasmids of A6 and V9 (not wild) • Exercice aimed at gathering information on state of the art detection EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

  9. OMCLs advisory group has recently endorsed the proposal that B19 guideline shall be updated and included • In Ph.Eur. As it is currently used by both OMCLs and manufacturers (see PMFs) EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007

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