Viral screening of couples undergoing partner donation in assisted reproduction with regard to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC: what is the evidence for repeated screening?

This paper concerns the requirements of the EU Tissue and Cells Directives with regard to the biological screening of donors of reproductive cells which are to be used for partner donation. We review the evidence regarding the risks of transmission of blood-borne viruses [hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV)] in the assisted reproductive technology (ART) setting. We document the experience in seven Irish ART clinics since the introduction of the legislation. Even among those known to be HBV-, HCV- or HIV-positive, when current best practice ART procedures are employed for gamete and embryo processing, cross-contamination in the ART facility or horizontal or vertical transmission to a partner or neonate has never been documented. When samples are processed and high-security straws are used for cryopreservation, transmission of virus and cross-contamination in storage have not been reported. While initial screening of those about to embark on ART treatment is good practice, we can find no medical or scientific evidence to support re-screening prior to each treatment cycle for individuals undergoing partner donation in ART. It would seem more appropriate to focus on risk reduction using a combination of initial baseline screening (with a reduced frequency of re-testing), appropriate sample processing and best possible containment systems for cryostorage.