Rondanelli R, Regazzi M B, Gastaldi L, Legnazzi P, Abelli P
Department of Pharmacology, IRCCS, Policlinico S. Matteo, Pavia, Italy.
Ther Drug Monit. 1990 Mar;12(2):182-6. doi: 10.1097/00007691-199003000-00012.
The Abbott TDx fluorescence polarization immunoassay (FPIA) procedure for measuring cyclosporine A (CsA) was evaluated and compared with the Sandoz polyclonal radioimmunoassay (CsA RIA kit) method. This drug assay was evaluated for precision, calibration, stability, and accuracy. Within-run precision studies utilizing 25 replicate analyses of the three control preparations (containing CsA in the 60-800 ng/ml range) resulted in coefficients of variation (CV) ranging from 1.0 to 9.1%. The CVs of between-run precision determined by assaying the same control drug levels for five consecutive working days ranged from 3.9 to 4.6%. Calibration curve stability was assessed by examining the drift in control values over a 2-week period. Maximum plasma ranged from 82.6 to 108.2%. Four hundred plasma samples were obtained from 30 heart-transplant patients during the first 6 months of CsA therapy and each sample was analyzed simultaneously by TDx and RIA. Linear regression analysis of the results obtained for each patient (x = RIA, y = FPIA) revealed the following mean values: r = 0.87, (CV = 13.7%), slope = 1.47 (CV = 39.2%). Moreover, the concentration of CsA was determined in 35 patient samples both by TDx and high-performance liquid chromatography (HPLC). FPIA results up to 12 times higher than HPLC results have been noted.
对雅培TDx荧光偏振免疫分析法（FPIA）测定环孢素A（CsA）的方法进行了评估，并与山德士多克隆放射免疫分析法（CsA RIA试剂盒）进行了比较。对该药物分析方法的精密度、校准、稳定性和准确性进行了评估。利用三种对照制剂（CsA浓度范围为60 - 800 ng/ml）进行25次重复分析的批内精密度研究，变异系数（CV）范围为1.0%至9.1%。通过连续五个工作日测定相同对照药物水平来确定的批间精密度的CV范围为3.9%至4.6%。通过检查两周内对照值的漂移来评估校准曲线的稳定性。最大血浆范围为82.6%至108.2%。在CsA治疗的前6个月期间，从30名心脏移植患者中获取了400份血浆样本，每个样本同时用TDx和RIA进行分析。对每位患者获得的结果（x = RIA，y = FPIA）进行线性回归分析，得出以下平均值：r = 0.87，（CV = 13.7%），斜率 = 1.47（CV = 39.2%）。此外，还通过TDx和高效液相色谱法（HPLC）对35份患者样本中的CsA浓度进行了测定。已注意到FPIA结果比HPLC结果高出12倍。
