Safety of blood products - update 2024

Currently, donor screening consists of a combination of serological detection methods to detect antigens and antibodies from viral and bacterial infections (HBsAg, anti-HBc, anti-HCV, anti-HIV, p24Ag, anti-syphilis) and molecular detection methods (nucleic amplification technology (NAT) for HCV, HIV-1, HEV, WNV). Based on a mathematical model, the current residual infection risks for HBV, HCV and HIV are 1:300000, 1:11 million and 1:4.3 million, respectively. This means that the residual infection risks for blood products are significantly lower than residual risks of other widely used drugs such as the use of erythropoietin (1:x1000 for hyperkalemia, hypersensitivity, seizures and congestion of the respiratory tract) or iron preparations (1:10000 for anaphylactic reactions, syncope and bronchospasm). Despite the shortening of the shelf life of platelet concentrates from 5 days to 4 days, the residual infection risk for a fatal, serious bacterial transmission is stated to be 1:400000 (approx. one fatal transmission per year in Germany). Pathogen reduction methods (Intercept, Mirasol or Theraflex) can reduce the risk of bacterial infections on a product-specific basis. The NAT technology offers great potential to implement new, previously irrelevant or unknown pathogens in donor screening at short notice. By means of intensive research in recent decades and the further development of serological and molecular detection methods, the safety of blood products in Germany has been raised to the highest international level and contributes to the fact that autologous blood donations are currently no longer relevant in everyday clinical practice.