Viral screening at the time of each donation in ART patients: is it justified?

The frequency for virology testing for couples undergoing assisted reproductive treatment (ART) in Europe is currently under debate, with little scientific data available to support the time-frame imposed by EU legislation. The aim of this study was to determine the incidence of blood-borne viruses (BBV) in this population and to assess the likelihood of seroconversion after an initial negative screen and the possible cost saving to couples.

We identified all cases where a BBV screen was performed on patients attending our tertiary referral unit for ART. We calculated the incidence of Hepatitis B surface antigen, Hepatitis C antibody and HIV infection in this population and the incidence of seroconversion in follow-up screening (which included Hepatitis B core antibody) following the implementation of the EU legislation. In all cases identified, we sought to assess the risk of seroconversion after an initial negative screen.

Between 1998 and 2009, we identified a total of 79 291 tests performed in over 12 500 patients. The incidence in this population of Hepatitis B surface antigen was 0.28% (37/12,797), Hepatitis B core antibody 3.32% (96/2891), Hepatitis C antibody 0.33% (43/12,762) and HIV 0.007% (1/12,819). We were able to show that for over 6500 individuals who were tested and re-tested for all three viruses, no seroconversions were reported.

Based on the above measured negligible risk of seroconversion after an initial negative screen in co-habitating couples participating in an ART programme, current legislation requiring screening of couples at each procurement of cells in the assisted reproductive setting is not clinically justified.