SoGAT Meeting, Berne, 14 June 2006 M. Nübling (PEI, Germany)

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SoGAT Meeting, Berne, 14 June 2006 M. Nübling (PEI, Germany) Results from recent EDQM/OMCL PTS Studies on B19 Virus DNA NAT Testing of Plasma Pools SoGAT Meeting, Berne, 14 June 2006 M. Nübling (PEI, Germany) K.H. Buchheit (EDQM, CoE)

Background Ph. Eur. Requirements NAT testing of plasma pools for manufacture of anti-D Ig: since 1/1/04 human plasma (pooled and virus inactivated): since 1/7/04 B19 virus DNA maximum: 104 IU/ml 104 IU/ml positive control included PTS studies once per year (start 2004) K.H. Buchheit, SoGAT 14/6/06

Organisation Organised by EDQM on behalf of OMCL network Scientific Advisor: M. Nübling (PEI) Open to OMCLs & manufacturers OMCLs 10 - 13 Manufacturers: 6 - 12 List of participants not disclosed K.H. Buchheit, SoGAT 14/6/06

Materials & Methods Panel (1 provided): NAT Methods: routine in-house 10 test samples: 1.2 ml (frozen) Negative samples B19 samples: 107 - 102 IU/ml A6 samples: ≈106, 102 IU/ml not known to participants obtained from J. Blümel (PEI) NAT Methods: routine in-house Roche and Artus kits used K.H. Buchheit, SoGAT 14/6/06

Results PTS052 (2004) K.H. Buchheit, SoGAT 14/6/06

Results PTS064 (2005) K.H. Buchheit, SoGAT 14/6/06

Results PTS052 & PTS064 Negative samples below 104 IU/ml by all labs 103 IU/ml samples correctly classified “pass” by all 1-2 lab(s) underestimated 105 IU/ml samples B19 104 IU/ml samples tested “pass” in > 50% of tests (mind uncertainty about ‘true’ concentration) 9 labs unable to detect A6 variant virus at 106 IU/ml Roche kit fails to amplify efficiently A6-variant Artus kit does not have this problem K.H. Buchheit, SoGAT 14/6/06

Conclusions Majority of participating laboratories were not able to detect a sample containing 106 IU/ml of virus variant A6 For virus type B19 performance is in general satisfactory (similar to HCV-NAT PTS) K.H. Buchheit, SoGAT 14/6/06