Schroeder T J, Pesce A J, Hassan F M, Wermeling J R, Warner A, Schlueter K T, First M R
Department of Pathology, University of Cincinnati Medical Center, OH.
Transplant Proc. 1988 Apr;20(2 Suppl 2):345-7.
We have had the opportunity to compare the new FPIA method for the measurement of serum Cs to established assays. The technique used a precipitation step prior to the fluorescence polarization measurement. We compared serum HPLC and RIA to the FPIA procedure. The within run coefficients of variation were 7.2%, 9.5%, and 4%, respectively. Between run CVs were 8.0%, 12.2%, and 3.8%. The correlation coefficient for HPLC and both of the immunoassays was less than 70%, showing the influence of the different specificities of the techniques. Medical centers that have based patient care on the HPLC assay that measures only parent drug will have difficulty using an immunoassay that measures a combination of parent and metabolites. There was a good correlation (R2 = 0.93) between the two immunoassays indicating that those currently using the serum RIA for monitoring could, through careful correlation studies in their patient population, use the FPIA technique. The regression equation was as follows: serum FPIA = 1.27 serum RIA + 1.9. This indicates the higher bias of the FPIA measurements. The advantages of the FPIA assay are that 20 assays could be done in less than one hour. This is in contrast to the longer turnaround time of the standard Sandoz RIA procedure. The technical competence required to perform the assay is less than that needed to perform the current RIA procedure. The assay can be recommended for replacement of the serum RIA; however, a correlation of levels with clinical experience is necessary in view of the difference in values between RIA and FPIA.
我们有机会将用于测量血清 Cs 的新荧光偏振免疫分析（FPIA）方法与既定检测方法进行比较。该技术在荧光偏振测量之前使用了一个沉淀步骤。我们将血清高效液相色谱法（HPLC）和放射免疫分析（RIA）与 FPIA 程序进行了比较。批内变异系数分别为 7.2%、9.5%和 4%。批间变异系数分别为 8.0%、12.2%和 3.8%。HPLC 与两种免疫分析方法的相关系数均小于 70%，这表明不同技术特异性的影响。那些基于仅测量母体药物的 HPLC 检测来进行患者护理的医疗中心，在使用测量母体和代谢物组合的免疫分析方法时会遇到困难。两种免疫分析方法之间存在良好的相关性（R2 = 0.93），这表明目前使用血清 RIA 进行监测的机构，通过在其患者群体中进行仔细的相关性研究，可以使用 FPIA 技术。回归方程如下：血清 FPIA = 1.27×血清 RIA + 1.9。这表明 FPIA 测量存在较高偏差。FPIA 检测的优点是在不到一小时内可以完成 20 次检测。这与标准的山德士 RIA 程序较长的周转时间形成对比。进行该检测所需的技术能力低于当前 RIA 程序所需的技术能力。该检测方法可推荐用于替代血清 RIA；然而，鉴于 RIA 和 FPIA 值的差异，有必要将检测水平与临床经验进行相关性分析。
