title: [Evaluation of sensitivity of an assay: application to a third-generation thyrotropin (TSH) assay].
abstract: The concentration-specific smallest detectable difference (D) between two concentrations (i.e., the sensitivity) was determined from the results of within-run and run-to-run reproducibility studies of a third-generation thyrotropin assay. Only low concentrations were considered (range 0-0.3 m U/l). Assays were performed in singlet or in duplicate. Findings confirmed the value of the assay: the analytic detection limit approximated 0.005 mU/l and the functional detection limit was around 0.01 mU/l. Expressed as a percentage of the concentration, D% was under 20% for levels of less than 0.02 mU/l in within-run studies or of less than 0.03 mU/l in run-to-run studies. With concentrations in excess of 0.05 mU/l, D% was under 10% in within-run studies and slightly above 10% in run-to-run studies. These new detection thresholds for this assay should be taken into account when interpreting clinical results from a single run (TRH test) or from several runs (hormone replacement therapy or suppression test).
authors.affiliation: Institut de Physique Biologique, Faculté de Médecine, Strasbourg, France.
authors.forename: R
authors.initials: R
authors.lastname: Sapin
authors.forename: F
authors.initials: F
authors.lastname: Gasser
authors.forename: J L
authors.initials: JL
authors.lastname: Schlienger
authors.forename: J
authors.initials: J
authors.lastname: Chambron
mesh_terms: D006801:Humans; D007159:Immunologic Tests; D015203:Reproducibility of Results; D013972:Thyrotropin / Q000032:analysis*
chemical_list: D013972:Thyrotropin
vernacular_title: Evaluation de la sensibilité d'une méthode de dosage: application à un dosage de thyrotropine (TSH) de troisième génération.