title: Scheme for the selection of measurement uncertainty models in blood establishments' screening immunoassays.
abstract: Blood establishments routinely perform screening immunoassays to assess safety of the blood components. As with any other screening test, results have an inherent uncertainty. In blood establishments the major concern is the chance of false negatives, due to its possible impact on patients' health. This article briefly reviews GUM and diagnostic accuracy models for screening immunoassays, recommending a scheme to support the screening laboratories' staffs on the selection of a model considering the intended use of the screening results (i.e., post-transfusion safety). The discussion is grounded on a "risk-based thinking", risk being considered from the blood donor selection to the screening immunoassays. A combination of GUM and diagnostic accuracy models to evaluate measurement uncertainty in blood establishments is recommended.
authors.affiliation: Department of Quality Assurance, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda 6, 1000-208 Lisbon, 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, Lisbon, Portugal.
authors.forename: Gracinda
authors.initials: G
authors.lastname: de Sousa
mesh_terms: D001771:Blood Banks / Q000592:standards; D001782:Blood Donors; D046148:Donor Selection / Q000379:methods / Q000592:standards; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D008962:Models, Theoretical; D000094902:Blood Banking / Q000379:methods
keywords: Diagnostic accuracy; GUM; Measurement uncertainty; Post-transfusion safety; Risk assessment; Screening tests