title: Evaluation of the Abbott IMx ultrasensitive II hTSH immunometric assay in three European centres: a comparison with established commercial immunometric assays for thyrotropin.
abstract: The Abbott Ultrasensitive II hTSH assay was evaluated in three European centres and its performance compared with its predecessor and with commercially available kits. A total of 408 individuals was included in the study (140 euthyroid, 116 hyperthyroid and 86 hypothyroid subjects, as well as 26 patients with non-thyroidal illness and 30 patients with thyroid cancer). The kit was evaluated for (im)precision and analytical and functional sensitivity according to ECCLS-Guidelines. The analytical sensitivity lay between 0.004 and 0.013 mU/1, the mean value being 0.008 mU/1, results being from 12 runs. The functional sensitivity gave a coefficient of variation below 20% at a concentration of 0.05 mU/1 under routine conditions. Inter-assay precision was less than 7% at 0.25 mU/l (range 5.3-6.8%), less than 6% at 6 mU/l (range 4.0-5.2%) and less than 9% at 30 mU/l (range 6.5 - 8.7%). Intra-assay (im)precision was not calculated as the Abbott IMx is designed to run on singlicate determinations.
authors.affiliation: Institut fur Klinische Laboratoriumsdiagnostik, Klinikum der Hansestadt Stralsund, Germany.
authors.forename: W G
authors.initials: WG
authors.lastname: Wood
authors.forename: U
authors.initials: U
authors.lastname: Bruns
authors.forename: O
authors.initials: O
authors.lastname: Eber
authors.forename: W
authors.initials: W
authors.lastname: Langsteger
authors.forename: J Y
authors.initials: JY
authors.lastname: Bounaud
authors.forename: M P
authors.initials: MP
authors.lastname: Bounaud
mesh_terms: D000328:Adult; D005069:Evaluation Studies as Topic; D006801:Humans; D007124:Immunoenzyme Techniques; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013959:Thyroid Diseases / Q000097:blood; D013972:Thyrotropin / Q000097:blood*
chemical_list: D011933:Reagent Kits, Diagnostic; D013972:Thyrotropin