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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‐ HB c. 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  HB sAg reactive only case and 23 anti‐ HB c 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.

Effectiveness of blood donor screening by HIV, HCV, HBV‐NAT assays, as well as HBsAg and anti‐HBc immunoassays in Germany (2008–2015)