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38.5 mln - population 1mln donations/year

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.

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38.5 mln - population 1mln donations/year

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  1. The current status of HCV, HIV, HBV NAT screeningEwa BrojerInstitute 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

  2. HCV NAT results (March 2000 - Dec 2004)

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

  4. 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

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

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

  7. 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

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

  9. 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

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

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

  12. 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; (-) (+)

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