EVALUATION OF THE ABBOTT IMX ULTRASENSITIVE II-HTSH IMMUNOMETRIC ASSAY IN 3 EUROPEAN CENTERS - A COMPARISON WITH ESTABLISHED COMMERCIAL IMMUNOMETRIC ASSAYS FOR THYROTROPIN

The Abbott Ultrasensitive II hTSH assay was evaluated in three Europea n centres and its performance compared with its predecessor and with c ommercially available kits. A total of 408 individuals was included in the study (140 euthyroid, 116 hyperthyroid and 86 hypothyroid subject s, as well as 26 patients with non-thyroidal illness and 30 patients w ith thyroid cancer). The kit was evaluated for (im)precision and analy tical and functional sensitivity according to ECCLS-Guidelines. The an alytical sensitivity lay between 0.004 and 0.013 mU/l, the mean value being 0.008 mU/l, results being from 12 runs. The functional sensitivi ty gave a coefficient of variation below 20% at a concentration of 0.0 5 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)preci sion was not calculated as the Abbott IMx is designed to run on singli cate determinations.