采用单克隆抗体和¹²⁵I示踪剂的特异性放射免疫分析法测定环孢素A。

Measurement of cyclosporine A by a specific radioimmunoassay with a monoclonal antibody and 125I tracer.

作者信息

Lee S C, Brudzinski A M, Yasmineh J L, Johanson N J, Ferber I A, Maas L K, Wong P Y, Keown P A, Orf J W

机构信息

INCSTAR Corporation, Stillwater, MN 55082.

出版信息

Clin Biochem. 1991 Feb;24(1):43-8. doi: 10.1016/0009-9120(91)90168-e.

DOI:10.1016/0009-9120(91)90168-e

PMID:2060131

Abstract

We developed a sensitive radioimmunoassay (CYCLO-Trac SP) that specifically measures cyclosporine A in serum, plasma and whole blood of transplant patients. The specific monoclonal antibody was from Sandoz and the tracer was an 125I derivative of cyclosporine C. The assay is performed at room temperature for 1 h followed by a 20 min centrifugation. The sensitivities of the assays are 2.6 ng/mL and 8.7 ng/mL for the serum/plasma assay and the whole blood assay, respectively. Within-run and between-run CVs for both types of assays using cyclosporine concentrations of 80 and 58 ng/mL (serum) and 186 and 199 ng/mL (whole blood) were less than 5% and 9%, respectively. Averaged recovery of serum/plasma and whole blood assays at various levels ranged from 93% to 115%. Interferences by bilirubin, triglyceride, cholesterol, hemoglobin, OKT-3, azathioprine, methylprednisolone and 20 other drugs were insignificant. Multicenter proficiency studies showed an excellent correlation between the CYCLO-Trac SP and the specific 3H-Sandimmune assay from Sandoz: whole blood assay (r = 0.998) and serum assay (r = 0.997).

摘要

我们开发了一种灵敏的放射免疫分析方法（CYCLO-Trac SP），可特异性检测移植患者血清、血浆和全血中的环孢素A。特异性单克隆抗体来自山德士公司，示踪剂是环孢素C的125I衍生物。该分析在室温下进行1小时，随后进行20分钟的离心。血清/血浆分析和全血分析的检测灵敏度分别为2.6 ng/mL和8.7 ng/mL。使用浓度为80和58 ng/mL（血清）以及186和199 ng/mL（全血）的环孢素进行的两种类型分析的批内和批间变异系数分别小于5%和9%。不同水平的血清/血浆和全血分析的平均回收率在93%至115%之间。胆红素、甘油三酯、胆固醇、血红蛋白、OKT-3、硫唑嘌呤、甲基强的松龙和其他20种药物的干扰不显著。多中心能力验证研究表明，CYCLO-Trac SP与山德士公司特定的3H-山地明分析之间具有极好的相关性：全血分析（r = 0.998）和血清分析（r = 0.997）。