title: Diagnosis: toxic!--trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations.
abstract: The assessment of relevance of toxicological testing was compared with approaches of diagnostic medicine, a discipline that faces a comparable situation. Considering the work of a toxicologist as setting a diagnosis for compounds, assessment tools for diagnostic tests were transferred to toxicological tests. In clinical diagnostics, test uncertainty is well accepted and incorporated in this assessment. Furthermore, prevalence information is considered to evaluate the gain in information resulting from the application of a test. Several common toxicological scenarios, in which test uncertainty and prevalence are combined, are discussed including the interdependence of test accuracy, prevalence and predictive values or the sequential application of a screening and a confirmatory test. In addition, real prevalences derived from prevalences determined by an imperfect test are presented. We conclude that information on prevalences of toxic health effects is required to allow a complete assessment of the relevance of toxicological test. In this process, lessons can be learned from evidence-based approaches in clinical diagnostics.
authors.affiliation: European Commission, JRC-Joint Research Centre, Institute for Health & Consumer Protection, ECVAM-European Centre for the Validation of Alternative Methods, 21020 Ispra (VA), Italy.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Hoffmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
mesh_terms: D003933:Diagnosis; D019317:Evidence-Based Medicine; D011786:Quality Control; D012015:Reference Standards; D018675:Toxicity Tests / Q000592:standards*