Napoli K L, Kahan B D
Department of Surgery, University of Texas Medical School, Houston 77030.
Transplant Proc. 1990 Jun;22(3):1175-80.
Among the new techniques available for CyA monitoring, the FPIA offers the advantages of rapidity and simplicity. The present communication assesses the technical performance of this test in comparison with a 3H tracer-based PC-RIA for serum CyA levels using 971 samples obtained during the first 6 posttransplant months from 14 kidney transplant recipients. The FPIA evaluation included verification of CyA concentrations in manufacturer-supplied calibrators and controls by reference methods, determination of intraassay/interassay precision and accuracy, feasibility of specimen dilution and assessed assay sensitivity, and range of linearity. Comparison of FPIA with PC-RIA indicated that trough samples, when assessed by FPIA, averaged 1.3-fold greater than the PC-RIA, whereas non-trough FPIA measurements indicated similarity between the two methods. Although the two assays showed similar trends in most renal transplant recipients, two subjects demonstrated discrepancies, presumably reflecting the differing specificities of the polyclonal antibodies used in each assay. Thus, the FPIA appears to be a useful addition to CyA monitoring technology.
在现有的用于环孢素A（CyA）监测的新技术中，荧光偏振免疫分析（FPIA）具有快速和简便的优点。本报告使用从14名肾移植受者移植后前6个月期间获得的971份样本，评估了该检测方法相对于基于3H示踪剂的放射免疫分析（PC-RIA）检测血清CyA水平的技术性能。FPIA评估包括通过参考方法验证制造商提供的校准品和对照品中的CyA浓度、测定批内/批间精密度和准确性、样本稀释的可行性以及评估检测灵敏度和线性范围。FPIA与PC-RIA的比较表明，用FPIA评估时，谷值样本平均比PC-RIA高1.3倍，而非谷值FPIA测量结果表明两种方法相似。尽管在大多数肾移植受者中两种检测方法显示出相似的趋势，但有两名受试者出现差异，这可能反映了每种检测方法中使用的多克隆抗体的不同特异性。因此，FPIA似乎是CyA监测技术的一项有用补充。
