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Abstract |
Performance of the Vitros ECI Analyzer-Comparison with other Immunoassay Systems for Determination of Thyroid Parameters |
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The Vitros ECI analyzer (manufactured by Ortho Clinical Diagnostics) was used to measure the thyroid parameters fT4, fT3 and TSH. Comparative analyses were performed on three other systems: Elecsys 2010- (Roche Diagnostics, formerly Boehringer Mannheim), Cobas Core- (Roche) and Access-system (Beckman). The assay achieves a range up to 100 mIU/l for TSH, 90 pmol/l for fT4 and 35 pmol/l for fT3. Dilution and linearity are good. Imprecision (% CV) within-run and between-day is <2.1 and, 10.5% for TSH, <2.0 and 7.3% for fT4 and <4.3 and 9.2% for fT3. The results for imprecision and inaccuracy fulfill the requirements of the German Medical Council (Bundesärztekammer) for quality assurance in medical laboratories. The assay shows good correlation with other commercially available assays: For TSH assays r = 0.990 - 0.998 with slopes of 0.835 - 1.071 and intercepts from - 0.003 up to 0.037 mIU/I, for fT4 assays r = 0.878 - 0.965 with slopes of 0.684 - 0.915 and intercepts between 0.806 and 4.08 pmol/l and for fT3 assays r = 0.922 - 0.954 with slopes of 0.813 - 0.820 and intercepts between -1.568 and 0.938 pmol/I. The Yitros ECI analyzer is easy to use, quick, precise and accurate for in vitro diagnosis of thyroid function. |
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