1. 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 M. Nübling (PEI, Germany)
K.H. Buchheit (EDQM, CoE)

2. 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

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

4. Materials & Methods Panel (1 provided): NAT Methods: routine in-house
10 test samples: 1.2 ml (frozen)
Negative samples
B19 samples: 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

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

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

7. 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
B 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

8. 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