Abstract
In this study we compared and validated commercial immunoradiometric assays (IRMA) to determine thyroglobulin (Tg) levels in serum. From a set of 440 samples, 68 were selected to calculate the validation parameters and the clinical performance of the assays. The commercial kits evaluated were the Tg‐CTK (DiaSorin), IRMAZenco Tg (ZenTech), and SELco‐Tg (Medipan). We found that 21% of the collected samples were in the critical range of concentration. Detection limits were calculated as being below 3 µg/L. Intra‐ and inter‐reproducibility were lower than 3.1% and 9.2%, respectively. Dilution and recovery studies provided quantitative determinations. Correlation regression coefficients from the results of the methods were obtained. The determined concentrations were compared with the clinical evidence of disease. Variation in the 125‐iodine‐labeled antibody concentration and control charts showed the robustness of the methods. Analysis time and the simplicity of the methods were also evaluated. Reliable Tg determination is important for monitoring patients with differentiated thyroid cancer (DTC), controlling other thyroid diseases, and assessing the quality of imaging techniques. A strategy for verification and comparison based on analytical parameters and clinical performance is proposed. J. Clin. Lab. Anal. 21:147–153, 2007. © 2007 Wiley‐Liss, Inc.
Keywords: immunoradiometric assay, IRMA, thyroglobulin, analytical validation
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