TDx环孢素及代谢物荧光偏振免疫分析的分析评估及其与Cyclo-Trac放射免疫分析试剂盒的比较。

Analytical evaluation of TDx cyclosporine and metabolites fluorescence polarization immunoassay and comparison with the Cyclo-Trac RIA kit.

作者信息

Montojo C, Calvo M V, Domínguez-Gil A

机构信息

Service of Pharmacy, Clinical Hospital, University of Salamanca, Spain.

出版信息

J Clin Pharm Ther. 1990 Feb;15(1):45-51. doi: 10.1111/j.1365-2710.1990.tb00355.x.

DOI:10.1111/j.1365-2710.1990.tb00355.x

PMID:2180968

Abstract

The fluorescence polarization immunoassay (FPIA) developed by Abbott Laboratories (TDx system) for the determination of cyclosporine in plasma was evaluated using whole blood as the analytical sample. The coefficients of variation for the within-run and between-run precision ranged from 3.7 to 5.7% and from 5.5 to 7.3%, respectively, for cyclosporine controls ranging in concentration from 200 to 1500 ng/ml. The detection limit was seen to be 26 ng/ml. We used specimens from renal transplant patients who received cyclosporine to compare the TDx assay with the RIA method (Incstar Cyclo-Trac). There was a good correlation between FPIA and RA results (r = 0.91; TDx = 1.29 RIA + 39.13; n = 88). It was concluded that the FPIA is an acceptable and rapid method for patient cyclosporine analysis in whole blood samples. In therapeutic drug monitoring this method offers advantages over the RIA procedure.

摘要

使用全血作为分析样本，对雅培实验室开发的用于测定血浆中环孢素的荧光偏振免疫分析法（FPIA，TDx系统）进行了评估。对于浓度范围为200至1500 ng/ml的环孢素对照品，批内精密度和批间精密度的变异系数分别为3.7%至5.7%和5.5%至7.3%。检测限为26 ng/ml。我们使用接受环孢素治疗的肾移植患者的样本，将TDx检测法与放射免疫分析法（Incstar Cyclo-Trac）进行比较。FPIA与放射免疫分析结果之间具有良好的相关性（r = 0.91；TDx = 1.29放射免疫分析 + 39.13；n = 88）。得出的结论是，FPIA是一种可接受的、用于全血样本中患者环孢素分析的快速方法。在治疗药物监测中，该方法比放射免疫分析程序具有优势。