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Are conversion factors to international units assay related?

Are conversion factors to international units assay related?. Marco Koppelman, Henk Reesink, Nico Lelie, Theo Cuypers. NAT test system for comparison. NucliSens Extraction Cobas Amplicor HCV Procleix Ultrio (Chiron/Gen-Probe) HIV-1, HCV, and HBV Multiprep Cobas AmpliScreen HBV

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Are conversion factors to international units assay related?

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

  2. 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 SoGAT 24-05-2005

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

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

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

  6. 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 SoGAT 24-05-2005

  7. Analytical sensitivityWHO International Standard HBV DNA (97/746) SoGAT 24-05-2005

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

  9. Conversion Factor between two data-sets Potency calculated with SPSS % positive 95% 50% 0 2 4 6 8 log (dilution) SoGAT 24-05-2005

  10. Conversion factors IU to Geq 1Koppelman et al. Transfusion 2005 in press. 2Koppelman et al. 2005 Submitted. 3Cuypers et al.; Biologicals. 1999 27 303-14. SoGAT 24-05-2005

  11. 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 SoGAT 24-05-2005

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

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

  14. Conversion factors IU to Geq 1Koppelman et al. Transfusion 2005 in press. 2Koppelman et al. 2005 Submitted. 3Cuypers et al.; Biologicals. 1999 27 303-14. SoGAT 24-05-2005

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