Between 1999 and 2006, the Paul-Ehrlich-Institut (PEI) introduced three additional screening tests complementing standard test procedures (HCV and HIV-1 genome, anti-HBc antibodies) as obligatory. A current evaluation provides proof of their benefit for the safety of blood components and blood products.
Blood safety is based on three pillars: donor selection, testing (screening tests), and pathogen inactivation. The latter method is used in the manufacture of blood products such as immunoglobulins. In Germany, the PEI Federal Institute for Vaccines and Biomedicines is responsible for the safety of blood components and blood products. Based on the haemovigilance data, additional screening tests were ordered by the PEI to reduce the risk of infection: the nucleic acid amplification test (NAT) for the detection of the hepatitis C virus genome (HCV) in 1999, the NAT for the detection of the HIV-1 virus genome in 2004, and the serological testing for antibodies against the hepatitis B-core antigen (anti-HBc) in 2006. In addition, around 98 percent of all blood donation centres introduced a NAT screening test for HBV on a voluntary basis between 2008 and 2010.
To assess the benefit of introducing individual search tests, scientific staff members of Division "Safety of medicines and medical devices" of the PEI performed a survey at all blood donation centres (Blutspendeeinrichtungen - BE). After the PEI received feedback from participating BE, the results of the screening tests were evaluated for the period between 2008 and 2015. These results were published in an article for Vox Sanguinis (online edition of 22 April 2019).
Based on data from around 46 million blood donations, it could be demonstrated that the newly introduced NAT search tests led to an additional amount of 0.43 HIV-1, 1.32 HCV-NAT, and 0.64 HBV detections per 1 million tested blood donations. The anti-HBc screening test detected an additional 0.55 cases or occult HBV infections per million tested blood donations, and in addition, altogether 23 cases in the study period of eight years. Occult infections are infections without detectable hepatitis B surface antigen (HbsAg), very low concentration of virus genome, and therefore often negative HBV-NAT results. In the observation period, no HCV, one HIV-1, and four HBV transmissions caused by transfusions were recorded. All transmissions could be put down to blood donations in the early stages after an infection, the so-called diagnostic window.
The data show that the screening tests for HIV, HCV, and HBV currently used in Germany provide a high standard of virus safety.
Updated: 28.05.2019
