title: The role of uncertainty regarding the results of screening immunoassays in blood establishments.
abstract: The risk of uncertain results in infectious agents' tests is recognized in blood establishments, being particularly evident during the blood donor selection. The current risk-based approaches require risk assessment and "risk-based thinking". Accordingly, the blood establishment should consider the effect of uncertainty in all the technical decisions taken in a screening laboratory. Since the post-transfusion safety is one of the blood establishments' goals, the risk of post-transfusion infection should be evaluated and actions taken to decrease the chance of blood donations validation use false negative results. This article reviews and discusses the sources of uncertainty of infectious agents' reported results in blood establishments. It describes a set of sources of uncertainty that should be considered in screening immunoassay's decisions. The infectious agents' uncertainty concern is critical for reporting reliable results.
authors.affiliation: Department of Quality Assurance, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda 6, 1000-208 Lisboa, Portugal. Electronic address: paulo.pereira@ipst.min-saude.pt.
authors.forename: Paulo
authors.initials: P
authors.lastname: Pereira
authors.affiliation: Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison, WI, USA.
authors.forename: James O
authors.initials: JO
authors.lastname: Westgard
authors.affiliation: Católica Lisbon School of Business and Economics, Catholic University of Portugal, Lisbon, Portugal.
authors.forename: Pedro
authors.initials: P
authors.lastname: Encarnação
authors.affiliation: International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategy, London, UK. Electronic address: jseghatchian@btopenworld.com.
authors.forename: Jerard
authors.initials: J
authors.lastname: Seghatchian
authors.affiliation: Directive Board, Portuguese Institute of Blood and Transplantation, Portugal.
authors.forename: Gracinda
authors.initials: G
authors.lastname: de Sousa
mesh_terms: D001771:Blood Banks / Q000592:standards*; D001782:Blood Donors; D001803:Blood Transfusion / Q000379:methods / Q000592:standards*; D046148:Donor Selection / Q000379:methods*; D005188:False Negative Reactions; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D012372:ROC Curve; D015203:Reproducibility of Results; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D035501:Uncertainty
keywords: Blood donor selection; Blood establishments; Infectious agents; Post-transfusion safety; Risk assessment; Screening immunoassay