Performance Characteristics of Six Third-Generation Assays for Thyroid-Stimulating Hormone

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Abstract
Background: Thyroid-stimulating hormone (TSH) is used to detect primary hypo- and hyperthyroidism. Current guidelines for TSH assays recommend a functional sensitivity of ≤0.02 mIU/L. The protocol for determining the functional sensitivity of TSH assays specifies analyses of serum samples with two reagent lots over a 6- to 8-week period. Methods: We determined the functional sensitivities of the Access 2, ADVIA Centaur, ARCHITECT i2000, E170, IMMULITE 2000, and Vitros ECi automated methods, using seven serum pools and two reagent lots for each method. Results: The observed functional sensitivities were as follows: Access 2, Conclusions: TSH methods do not provide comparable results for serum pools with TSH concentrations <0.2 mIU/L or for patient results across the analytic measurement range. Further investigation into the cause of these differences and additional harmonization efforts are required.