title: A statistical approach to assess analytical sensitivity of diagnostic assays in the presence of false-positive results.
abstract: Analytical sensitivity is one of the performance characteristics of diagnostic tests. As always, a subtle balance has to be found between sensitivity and specificity, but given the clinical setting and the intended use of the diagnostic system, a less than 100% specificity can be perfectly acceptable. Probit analysis is a wide-spread statistical technique used to assess the concentrations corresponding to pre-set hit rates, but this technique assumes a 100% specificity. The current paper describes a statistical procedure, derived from the standard probit technique, to deal with the incidence of false-positive results in the assessment of the analytical sensitivity.
authors.affiliation: Department of Biomathematics, bioMérieux BV, P.O. Box 84, 5280 AB Boxtel, The Netherlands.
authors.forename: Jos J A M
authors.initials: JJAM
authors.lastname: Weusten
mesh_terms: D003951:Diagnostic Errors / Q000706:statistics & numerical data*; D005189:False Positive Reactions; D006801:Humans; D007202:Indicators and Reagents; D008962:Models, Theoretical; D012680:Sensitivity and Specificity
chemical_list: D007202:Indicators and Reagents