Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States

Over the past two decades, based on ongoing concern about blood safety, increasingly sensitive tests have been implemented for the detection of transfusion-transmitted viral antibodies and antigens in donated blood. Nevertheless, transmission of viral agents can still occur during the window period (WP), defined as the time from infection to the time that a blood screening assay becomes positive. Relative to antibody and antigen tests, this WP ranges from a few weeks to a few months for new infections with the major transfusiontransmitted viruses [hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV)] [1,2]. Nucleic acid testing (NAT) is a sensitive method for virus detection in the antibody-negative WP that should further reduce the risk of infection by blood transfusion [2–4]. In the past two years, HCV and HIV NAT systems have been licensed for blood screening in the United States (US) and are performed on minipools consisting of samples from 16 to 24 donations, but, to date, the Food and Drug Administration (FDA) has not issued a formal requirement for testing. Correspondence: Deborah Marshall, Innovus Research Inc., 1016-A Sutton Drive, Suite 200, Burlington, Ont., Canada L7L 6B8. E-mail: