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.

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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 Biological Standardisation, OMCL Network and Health Care- EDQM - Council of Europe Strasbourg

EDQM-HC review of activities in Blood area by J-M SPIESER IPPC Wien 6 march 2007 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 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 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 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 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 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 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 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)