1. 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

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. 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

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/ 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
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. 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;
(+)
(-)