K.H. Buchheit, A. Daas, C.M. Nübling, J.M. Spieser 3 July 2003

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Presentation transcript:

K.H. Buchheit, A. Daas, C.M. Nübling, J.M. Spieser 3 July 2003 SoGAT XVI Collaborative Study for Establishment of a Ph. Eur. BRP for B19 Virus DNA Testing of Plasma Pools by NAT K.H. Buchheit, A. Daas, C.M. Nübling, J.M. Spieser 3 July 2003

Candidate BRP B19 positive plasma (ca 109 IU/ml), from window phase Liquid bulk material (106 IU/ml) Diluent: Human plasma negative for HCV, HBV, HIV1 (NAT & serology) Lyophilisation: ca 5400 vials, 0.5 ml residual water: 0.98 ± 0.65% K.H. Buchheit SoGAT 3/7/03

Collaborative study 16 labs (OMCLs, manuf., NAT test labs, kit manuf.) Calibration vs 1st IS (500 000 IU/vial) B19 negative plasma as dilution matrix Qualitative assay (13 labs) 4 independent tests dilution series proposed ≥ 3 half-log dil. around dilutional end point Quantitative assay (5 labs) Measure in parallel, diff. conc., linear range K.H. Buchheit SoGAT 3/7/03

Results (1) (Values as log10 IU/ml) Qualitative assay (n = 12) 5.64 ± 0.17 (C.L.: 67 - 150%) Quantitative assay (n = 5) 5.83 ± 0.05 (C.L.: 88 - 113%) Combined 5.80 ± 0.05 (C.L.: 86 - 117%) 630 957 IU/ml K.H. Buchheit SoGAT 3/7/03

Grey cells: qualitative assays Black cells: quantitative assays Results (2) Grey cells: qualitative assays Black cells: quantitative assays K.H. Buchheit SoGAT 3/7/03

cBRP suitable for intended purpose Assigned potency: 105.8 IU/ml Dilution for threshold control: 1/101.8 = 1/63 No. positive results/ no. assays for each dilution K.H. Buchheit SoGAT 3/7/03

Next Steps OMCL guideline for B19 NAT validation (M. Nübling) Validation panel PTS studies for OMCLs & manufactures (if requested) K.H. Buchheit SoGAT 3/7/03