title: Modeling complete removal of risk assessment questions in the USA predicts the risk of HIV exposure in blood recipients could increase despite the use of nucleic acid testing.
abstract: OBJECTIVE
  The safety of the blood supply in a number of countries is achieved by interventions that include behaviour-based time-limited or indefinite deferrals and screening of donated units for transfusion-transmitted infections. The relatively high sensitivity of nucleic acid testing (NAT) used in blood donor screening has raised the question of whether such time-based deferrals can be eliminated in favour of individual risk assessment.
  
  
  METHODS
  Data on the annual number of incident human immunodeficiency virus (HIV) infections associated with various behaviours and on the performance characteristics of NAT applied to donor screening were used to model the number of potentially infected units that might escape detection in the worst-case scenario in which individual risk assessment was implemented, but was not effective as a screening tool, and donors did not otherwise self-select for lower risk.
  
  
  RESULTS
  In the absence of effective individual risk-based screening or donor self-selection, the model predicts that in the United States, an additional 39 (95% CI 35-43) HIV-infected units would escape detection by nucleic acid testing, potentially capable of exposing approximately 68 (95% CI 61-75) individuals to the risk of HIV infection through the administration of prepared blood components.
  
  
  CONCLUSIONS
  Despite some inherent uncertainty, the worst-case scenario of completely ineffective individual risk assessment, absence of donor self-selection and increased reliance on NAT for blood screening is estimated to be associated with an approximately fourfold increase in the risk of HIV exposure through transfusion in the United States.
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: H
authors.initials: H
authors.lastname: Yang
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: S A
authors.initials: SA
authors.lastname: Anderson
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: R
authors.initials: R
authors.lastname: Forshee
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: A
authors.initials: A
authors.lastname: Williams
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Epstein
authors.affiliation: Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: P W
authors.initials: PW
authors.lastname: Marks
mesh_terms: D001782:Blood Donors; D058731:Blood Safety; D001803:Blood Transfusion; D006678:HIV / Q000235:genetics* / Q000302:isolation & purification; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D006801:Humans; D008962:Models, Theoretical; D021141:Nucleic Acid Amplification Techniques; D012367:RNA, Viral / Q000032:analysis*; D018570:Risk Assessment; D014481:United States
chemical_list: D012367:RNA, Viral
keywords: NAT; blood donation testing; blood safety; donors; residual risk estimation; transfusion medicine