Papadea C, Papadea N A, Cate J C, Didyk R B
Department of Pathology and Laboratory Medicine, College of Dental Medicine, Medical University of South Carolina, Charleston 29425, USA.
Ann Clin Lab Sci. 1998 Mar-Apr;28(2):88-98.
This study was conducted to evaluate the analytical performance (functional sensitivity, reproducibility, parallelism, and accuracy) of two recent commercial kits marketed as third generation immunometric assays for measuring serum thyroid stimulating hormone (TSH). One assay is automated; the other is manual. Accuracy by method comparisons was evaluated using 86 patient samples assayed by an established third generation immunometric assay as the comparative method. The new assays met the third generation criterion for functional sensitivity (CV < or = 20 percent at TSH < or = 0.02 mIU/L), were reproducible (CVs < 11 percent), and measured serum TSH in parallel with the calibrator curves. Linear regression analysis of the intermethod comparison data showed highly correlated (R > .095) results; however, the regression slopes were non-unity, indicating patient sample results were not transferable between methods. Clinical laboratories choosing a third generation TSH assay should validate the performance characteristics of the selected method to ensure reliable results for patient care.
本研究旨在评估两种最近上市的作为第三代免疫测定法用于测量血清促甲状腺激素（TSH）的商业试剂盒的分析性能（功能灵敏度、重复性、平行性和准确性）。一种测定法是自动化的；另一种是手动的。通过方法比较评估准确性，使用由既定的第三代免疫测定法测定的86份患者样本作为比较方法。新的测定法符合第三代功能灵敏度标准（在TSH≤0.02 mIU/L时CV≤20%），具有可重复性（CV<11%），并且与校准曲线平行测量血清TSH。方法间比较数据的线性回归分析显示结果高度相关（R>.095）；然而，回归斜率不一致，表明患者样本结果在不同方法之间不可转移。选择第三代TSH测定法的临床实验室应验证所选方法的性能特征，以确保为患者护理提供可靠的结果。
