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  • Title: Evaluation of the Abbott IMx ultrasensitive II hTSH immunometric assay in three European centres: a comparison with established commercial immunometric assays for thyrotropin.
    Author: Wood WG, Bruns U, Eber O, Langsteger W, Bounaud JY, Bounaud MP.
    Journal: Eur J Clin Chem Clin Biochem; 1996 Feb; 34(2):151-8. PubMed ID: 8833649.
    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.
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