Residual Risk of Hepatitis-B-Infected Blood Donations: Estimation Methods and Perspectives

Despite a considerable reduction of the risk of HBV-infected blood donation entering blood supply (residual risk) due to improved screening by HBV NAT in the developed countries, the bulk of the people with HBV living in the developing countries still needs to be screened by serologic tests such as HBsAg and anti-HBc. Many of these countries lack resources for implementing NAT and are likely to remain so in the next decade or longer, thus depending on the HBV residual risk monitoring based on serologic testing and corresponding estimation methods. This paper reviews main HBV residual risk findings worldwide and the methods based on serology used for their calculation with repeat donors, as well as their extension to the first-time donors. Two artificial datasets with high (4.36%) and low (0.48%) HBV prevalence were generated to test the performance of five methods: the original incidence/window-period model based solely on HBsAg, its modification by Soldan in 2003, the Muller-Breitkreutz model, the HBsAg yield model, and its extension to include anti-HBc seroconversions within a year. The last model was closest to the true values of residual risk and had smallest variation of the estimates in both high and low prevalence data. It may be used for residual risk evaluation in relatively small samples, such as regional blood banks data.