Large–Scale HCV RNA Screening in First–Time Blood Donors: The First Step Towards Genomic Screening of Blood Donations

Abstract

Background and Objectives: Individual genomic screening for viruses in blood donations is becoming increasingly pressing as an alternative to pool testing to improve the safety of the blood supply. Materials and Methods: To determine the feasibility and, possibly, efficacy of genomic screening for hepatitis C virus (HCV) in the blood service setting, a representative population of first–time blood donors was screened individually with a semi–automated genomic amplification assay for HCV RNA. First–time blood donors in two blood centres in the United Kingdom were screened in parallel for anti–HCV and HCV RNA by RT–PCR. Results: 8,417 serum samples were screened. A 99.95% specificity was observed and one anti–HCV–positive, HCV–RNA–positive donation was found. No seronegative HCV–RNA–positive donations were detected. Conclusions: These results are consistent with the low prevalence of HCV infection in blood donors from the London area and demonstrate the high level of performance of the individual genomic screening method used in this study. When fully automated, such a method would be a highly suitable candidate for routine, automated genomic screening of HCV and, subsequently, of other pathogenic blood–borne viruses.