Serology - anti-HCV. anti-HIV, HBsAg NAT - HCV RNA - since 2000

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Serology - anti-HCV. anti-HIV, HBsAg NAT - HCV RNA - since 2000 The current status of HCV, HIV, HBV NAT screening Ewa Brojer Institute of Hematology and Blood Transfusion, Warsaw, Poland Serology - anti-HCV. anti-HIV, HBsAg NAT - HCV RNA - since 2000 HIV RNA HBV DNA no anti-HBc 38.5 mln - population 1mln donations/year since 2005

HCV NAT results (March 2000 - Dec 2004)

High frequency of HCV ”window period” donors in Poland (2000-2004)

Study of HCV „window period” donors anti-HCV seroconversion in all donors introduction of epidemiological questionaire to identify the source and date of infection „look back” studies of all repeat donors

HCV RNA detection in “ look back” samples of HCV RNA positive/anti-HCV negative repeat blood donors

Since 2005 - HBV, HCV and HIV NAT BALTIC SEA LITHUANIA RUSSIA BELARUS UKRAINE SLOVAKIA CZECH REP. Słupsk Olsztyn Zielona Góra Wałbrzych Wrocław Łódź Kraków Radom Kielce Katowice Opole Szczecin Lublin Gdańsk Bydgoszcz Białystok Poznań Kalisz Racibórz Rzeszów Warszawa GERMANY Cobas Ampliscreen (Roche): 24 donation plasma pools TMA HCV/HIV/HBV (Chiron): single donations Reference Lab IHBT, Warsaw: certification for all NAT Laboratories

Why HBV DNA testing in pools „not larger than 24 donations”? Effectivity of plasma pool Cobas Ampliscreen testing revealed in preliminary study: 2 HBV DNA positives/60 000 dodations tested in 24 donation pools No preliminary studies with TMA single donation testing Higher sensitivity of Cobas Ampliscreen than Chiron TMA Lower price in tenders

HBV DNA detection in HBsAg negative blood donors *Discrepancies between ULTRIO and HBV Discrimination

Serological and molecular characteristics Serological and molecular characteristics* of HBV DNA (+)/HBsAg(-) donors *with participation of dr Zaaijer, dr Koppelman and dr Laperche ** HBsAg pos in PRISM test Detected by: mini-pool testing, single dontion testing

Examples of HBV Ultrio discrepant samples *Nuclisens Extractor (Organon Tecnika)

Examples of HBV DNA detection in Ultrio discrepant samples *Nuclisens Extractor (Organon Technika)

HBV Discrimination (+) Algorithm for HBV DNA detection in HBsAg negative donors ULTRIO (+) HBV Discrimination (+) ULTRIO ( +) Discrimination (-) Donor is HBV DNA positive Repeat ULTRIO (-) Donor is HBV DNA negative (+) Cobas Ampliscreen DNA from 2 ml of plasma by Nuclisens Extractor; (+) (-)