Nucleic Acid Amplification Tests for HIV, HBV, und HCV in Tissue Donors: Useful or Dispensable?

With the conversion of the EU-Guidelines 2004/23/EC and 2006/17/EC in the tissue law as well as the accompanying regulations (AMWHV, TPG-GewV), the fundamental requirements were defined for the virus safety of tissue donations. While serologic testing (anti-HIV 1/2, anti-HCV, hepatitis B surface antigen, anti-hepatitis B core antigen, Treponema pallidum hemagglutination assay) is compulsory, nucleic acid analysis for HIV, HBV and HCV is not explicitly required. On the basis of virus transmissions, tissue-specific characteristics as well as manufacture and, where applicable, inactivating procedures reported in the literature, an evaluation was made of the significance of HIV/HCV/HBV detection by nucleic acid amplification techniques (NAT) in donors of various tissues and compared with the experiences with blood donations. Musculoskeletal tissues possess a significant risk of transmitting HIV/HCV/HBV as a result of the mostly high blood content in tissues, the comprehensive extraction spectrum, the transmissions described to date, the different manufacturing processes as well as the high donor-recipient ratio. Therefore, with donated musculoskeletal tissues that do not undergo an effective virus-inactivating procedure, HIV-, HCV- und HBV-NAT testing should be performed. Serological testing assures that cardiovascular tissue has a very small residual risk of HIV/HCV/HBV transmission. Due to the impossibility of an effective virus inactivation (preservation of the tissue morphology) and a donor-recipient ratio of up to 1:10, HIV-, HCV- and HBV-NAT should, however, be performed as an additional safety precaution. Corneas possess the smallest HIV/HBV/HCV transmission risk from a physiological, morphological as well as an epidemiological viewpoint; however, HCV- NAT should be performed. In principle, quarantine storage of the tissues from a donor can be omitted in cases of negative HIV/HCV/HBV-NAT results. Due to the multifaceted synergetic effects with transfusion medicine, an obvious choice for tissue banks is the implementation of infectious serology and/or molecular-biological laboratory parameters in cooperation with blood bank services.