Vox Sang 2019 Apr 22. Epub 2019 Apr 22.
Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Langen, Germany.
Background And Objectives: In Germany, in addition to standard blood donor screening, further mandatory tests were introduced for HCV-RNA, HIV-1-RNA and for anti-HBc. Screening for HBV-DNA is optional. This study investigates the benefits of these additional tests for the detection of HIV, HCV, and HBV infections among German blood donors.
Materials And Methods: From 2008 to 2015 we collected data on blood donations exclusively testing NAT positive (NAT yield) or reactive in only one of the screening assays. Assuming a Poisson distribution, we calculated NAT yield/reactive only rates on a per donation basis (number of yield/reactive only cases divided by the number of donations tested in the period under review) with 95% confidence intervals.
Results: Responding establishments covered 95% of the donations. We identified 20 HIV-1-NAT, 61 HCV-NAT and 29 HBV-NAT yield cases among approximately 46 million blood donations tested corresponding to 0·43 HIV-1 NAT, 1·32 HCV-NAT, and 0·64 HBV-NAT yield cases per million blood donations tested. For one HBsAg reactive only case and 23 anti-HBc reactive only cases in repeat donors, infection was confirmed by ID-NAT which translates into 0·02 and 0·55 cases per million donations tested. During the 8-year-observation period, one HIV-1, no HCV and four HBV transmissions associated with donations in the viremic pre-seroconversion window period were reported.
Conclusion: Annually, NAT screening alone detected 2·5 HIV-1, 7·6 HCV, and 3·6 HBV infectious donations; anti-HBc screening alone identified 2·9 infectious donations of repeat donors with occult HBV infection. Overall, the survey results support that the currently practiced donor HIV/HCV/HBV screening strategy in Germany does ensure a high standard of blood safety.