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

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Presentation transcript:

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

SoGAT 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 NucliSens Extraction Cobas Amplicor HCV Generic silica extraction ‘Boom’ Technology Cobas Amplicor Nuclisens

SoGAT 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

SoGAT AmpliPrep TNAI Cobas AmpliScreen HIV/HCV/HBV Generic magnetic silica extraction AmpliPrepCobas Amplicor

SoGAT 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 Analytical sensitivity WHO International Standard HBV DNA (97/746) IU/mLMulti- Prep Ampli- Prep Ultrio n=24 n= % % % 98 % 590 %96 %76 % %71 %58 % %50 %27 % %46 %13 % %13 %6 % %13 %8 % %

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

SoGAT log (dilution) Conversion Factor between two data-sets 95% 50% % positive Potency calculated with SPSS

SoGAT Conversion factors IU to Geq AmpliScreen WHO studiesUltrio 1 AmpliPrep 2 MultiPrep 2 AmpliCor 3 HIV ( ) 1.6 ( ) -- HCV (5.8-84) 9.4 (3.3-43) -5.1 ( ) HBV (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 Submitted. 3 Cuypers et al.; Biologicals

SoGAT 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 Conversion factor Dutch guilder to Euro What was the conversion factor between Euro and Guilder in 2001? It makes no difference !

SoGAT Analytical Sensitivity AmpliScreen HIV-1/HCV/HBV AmpliPrep MultiPrep

SoGAT Conversion factors IU to Geq AmpliScreen WHO studiesUltrio 1 AmpliPrep 2 MultiPrep 2 AmpliCor 3 HIV HCV HBV Koppelman et al. Transfusion 2005 in press. 2 Koppelman et al Submitted. 3 Cuypers et al.; Biologicals