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Ewa Brojer , Grzegorz Liszewski , Aneta Kopacz ,

The effect of NAT sensitivity on the yield of HBV DNA, HCV RNA and HIV RNA detection in seronegative donations. Ewa Brojer , Grzegorz Liszewski , Aneta Kopacz , Piotr Grabarczyk , Magdalena Łetowska and Polish Blood Transfusion Ser v ice Viral Study Group

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Ewa Brojer , Grzegorz Liszewski , Aneta Kopacz ,

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  1. The effect of NAT sensitivity on the yield of HBV DNA, HCV RNA and HIV RNA detection in seronegative donations EwaBrojer, GrzegorzLiszewski, AnetaKopacz, PiotrGrabarczyk, Magdalena Łetowska and Polish Blood Transfusion Service Viral Study Group Institute of Haematology and Transfusion Medicine, Warsaw, Poland

  2. METHODS TMA (ID) HCV/HIV-1 HCV/HBV/HIV-1 Tigris PCR Cobas (pools) Ampliscreen HCV (48) HBV/HCV/HIV (24) s201 (6) 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 NAT screening systems - Poland1 milliondonation/year

  3. The aim of the study • to compare the analytical and clinical sensitivityof three NAT screening systems: • Cobas Ampliscreen - in pools of 24 • Cobas S201 - in pools of 6 • Procleix Ultrio (Tigris) - IDT for detection of window period of HIV, HCVand HBV infection and occult HBV infection

  4. Material and methods • 1 595 534 donations - screened by Cobas Ampliscreen in pools of 24 • 632 670 donations - by Cobas 201 in pools of 6 • 1439 221 single donations- screened by Procleix TMA • 238 971 – screened by Procleix HCV/HIV-1 TMA • 1 151 652 - screened by Procleix Ultrio TMA • The sensitivity of methods was tested using WHO HCV 96/790, 96/798; WHO HIV-1 97/650; WHO HBV 97/746 standards.

  5. Analitical sensitivity of NAT assays

  6. . The yield of HCV RNA, HBV DNA and HIVRNA in seronegative blood donors

  7. Conclusions: • The yield of HCV RNA is not influenced by the sensitivity of the NAT • The yield of HBV window period and occult is highly influenced by the sensitivity of the test • The screening using Cobas s201 in pools of 6 and Procleix Ultrio TMA in single donations give similar yield of both window period and occult HBV infection, • The frequency of HIVwindow period donations is to low for conclusion

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