Kagawa Yoshiyuki, Iwamoto Takuya, Matsuda Hiroaki, Mukohara Rika, Sawada Jun-ichi, Kojima Michio
Department of Hospital Pharmacy, Mie University School of Medicine, Edobashi 2-174, Tsu-city, Mie 514-8507, Japan.
Biopharm Drug Dispos. 2004 Jan;25(1):21-6. doi: 10.1002/bdd.382.
Digoxin concentrations measured by three automated immunoassay systems, i.e. OPUS, TDx and IMx assays, were compared in order to evaluate precision and accuracy performance, and data compatibility. Coefficients of variation for all methods in within-run and between-run precision were less than 10% at weighed-in concentrations of 0.545, 1.090 and 2.180 ng/ml. The accuracy relative to the three weighed-in concentrations ranged from 97% to 123% for all methods. One hundred and three plasma samples from 60 patients receiving digoxin were used to evaluate the data compatibility. Digoxin concentrations measured by the three immunoassay systems correlated well with one another. These results suggest that there are few problems when switching between digoxin assay methods, and that IMx and OPUS are more useful than TDx because they do not require sample pretreatment. The digoxin concentrations of the plasma samples from one patient receiving both digoxin and potassium canrenoate were investigated as a case report. The digoxin concentrations measured by TDx and IMx became higher than those measured by OPUS after starting the combination treatment. In another patient suffering from bilirubinaemia, the digoxin concentrations measured by TDx or IMx were higher than those measured by OPUS. These results suggest that OPUS has a higher specificity for measuring the plasma digoxin concentrations compared with TDx or IMx.
比较了通过三种自动免疫分析系统（即OPUS、TDx和IMx分析）测量的地高辛浓度，以评估精密度、准确性和数据兼容性。在0.545、1.090和2.180 ng/ml的称重浓度下，所有方法的批内和批间精密度变异系数均小于10%。所有方法相对于三种称重浓度的准确度在97%至123%之间。使用来自60名接受地高辛治疗患者的103份血浆样本评估数据兼容性。通过三种免疫分析系统测量的地高辛浓度之间相关性良好。这些结果表明，在地高辛分析方法之间切换时问题较少，并且IMx和OPUS比TDx更有用，因为它们不需要样本预处理。作为病例报告，研究了一名同时接受地高辛和坎利酸钾治疗患者的血浆样本中的地高辛浓度。联合治疗开始后，TDx和IMx测量的地高辛浓度高于OPUS测量的浓度。在另一名患有胆红素血症的患者中，TDx或IMx测量的地高辛浓度高于OPUS测量的浓度。这些结果表明，与TDx或IMx相比，OPUS在测量血浆地高辛浓度方面具有更高的特异性。
