1. SoGAT 24-05-2005 24 May 2005 Are conversion factors to international units assay related? Marco Koppelman, Henk Reesink, Nico Lelie, Theo Cuypers

2. SoGAT 24-05-2005 NAT test system for comparison NucliSens Extraction Cobas Amplicor HCV Procleix Ultrio (Chiron/Gen-Probe) HIV-1, HCV, and HBV Multiprep Cobas AmpliScreen HBV AmpliPrep TNAI Cobas AmpliScreen HIV vrs 1.5 AmpliPrep TNAI Cobas AmpliScreen HCV vrs2.0 AmpliPrep TNAI Cobas AmpliScreen HBV

3. SoGAT 24-05-2005 NucliSens Extraction Cobas Amplicor HCV Generic silica extraction ‘Boom’ Technology Cobas Amplicor Nuclisens

4. SoGAT 24-05-2005 Procleix Ultrio HIV-1, HCV, and HBV Results Luminometer Detection Water bath TMA Water baths Pipetting TECAN 2 Sample Processing TCS Specific Capture of Target

5. SoGAT 24-05-2005 AmpliPrep TNAI Cobas AmpliScreen HIV/HCV/HBV Generic magnetic silica extraction AmpliPrepCobas Amplicor

6. SoGAT 24-05-2005 Reference materials Serial dilutions of the WHO International standards for: HBV genotype A * (NIBSC 97/746) HIV-1 genotype B * (NIBSC 97/656) HCV genotype 1 * (NIBSC 96/790) *IU: Calibrated in WHO Collaborative Studies. PeliCheck reference panels for HBV genotype A # (S2184) HIV-1 genotype B # (S2092) HCV genotype 1 # (S2088) # Geq: Calibrated with Bayer bDNA

7. SoGAT 24-05-2005 Analytical sensitivity WHO International Standard HBV DNA (97/746) IU/mLMulti- Prep Ampli- Prep Ultrio n=24 n=63 40100% 20100 % 10100 % 98 % 590 %96 %76 % 2.586 %71 %58 % 1.2571 %50 %27 % 0.6333 %46 %13 % 0.3136 %13 %6 % 0.169 %13 %8 % 0.080 %

8. SoGAT 24-05-2005 Analytical Sensitivity Procleix Ultrio test * * Multicenter study; Assal (BC-Tours), Chudy (PEI), Garcia de Villaescusa (BC-Madrid), Koppelman (Sanquin). Transfusion in press.

9. SoGAT 24-05-2005 02468 log (dilution) Conversion Factor between two data-sets 95% 50% % positive Potency calculated with SPSS

10. SoGAT 24-05-2005 Conversion factors IU to Geq AmpliScreen WHO studiesUltrio 1 AmpliPrep 2 MultiPrep 2 AmpliCor 3 HIV-111.7 (1.2-4.3) 1.6 (0.9-2.7) -- HCV3.817.0 (5.8-84) 9.4 (3.3-43) -5.1 (3.1-9.1) HBV7.420.7 (9.1-60) 12.5 (5.4-40) 11.0 (4.9-33) - 1 Koppelman et al. Transfusion 2005 in press. 2 Koppelman et al. 2005 Submitted. 3 Cuypers et al.; Biologicals. 1999 27 303-14.

11. SoGAT 24-05-2005 Conversion factors between IU and copies/ml are assay specific Conversion factors of the WHO collaborative studies; the mean of different nucleic acid extraction techniques and amplification/detection systems (considerable interlaboratory variation) Molecular composition of the reference material Physical composition reference materials. Liquid versus lyophilized reference materials Commutability of reference materials; knowledge of molecular characteristics of preparations is necessary Preliminary conclusion: conversion factors from IU to VQC-geq assay specific

12. SoGAT 24-05-2005 Conversion factor Dutch guilder to Euro What was the conversion factor between Euro and Guilder in 2001? It makes no difference !

13. SoGAT 24-05-2005 Analytical Sensitivity AmpliScreen HIV-1/HCV/HBV AmpliPrep MultiPrep

14. SoGAT 24-05-2005 Conversion factors IU to Geq AmpliScreen WHO studiesUltrio 1 AmpliPrep 2 MultiPrep 2 AmpliCor 3 HIV-111.71.6-- HCV3.817.09.4-5.1 HBV7.420.712.511.0- 1 Koppelman et al. Transfusion 2005 in press. 2 Koppelman et al. 2005 Submitted. 3 Cuypers et al.; Biologicals. 1999 27 303-14.