Holt D W, Johnston A, Marsden J T, Vernillet L, Keown P A, Rosano T G, Shaw L M, Rosenthaler J
Poisons Unit, Guy's Hospital, London, U.K.
Clin Chem. 1988 Jun;34(6):1091-6.
The performance of a radioimmunoassay kit containing monoclonal specific and nonspecific antibodies to cyclosporine (Sandimmun-Kit; Sandoz Ltd., Basle, Switzerland) was compared with that of the original Sandoz polyclonal radioimmunoassay kit (Ciclosporin RIA-Kit). A total of 1320 blood and plasma samples from patients receiving cyclosporine after kidney, heart, liver, and bone-marrow transplantation were analyzed at six centers. For blood samples the median result on using the specific assay was about 50% of the polyclonal assay result after kidney and bone-marrow transplantation, about 33% after heart and liver transplantation; comparable figures for plasma samples were 70 and 40%. The monoclonal nonspecific-antibody assay produced results 10% to 140% higher than polyclonal-assay results, depending on sample matrix and transplant indication; the largest difference was seen in samples from heart- and liver-transplant recipients. Evidently the specific-antibody assay provides a convenient alternative to high-performance liquid chromatography for specific measurement of the drug, but the role of the new nonspecific antibody, possessing an even broader spectrum of cross-reactivity with cyclosporine metabolites than the original polyclonal antiserum, has yet to be defined.
将含有环孢素单克隆特异性和非特异性抗体的放射免疫分析试剂盒（Sandimmun试剂盒；瑞士巴塞尔山德士有限公司）的性能与山德士原有的多克隆放射免疫分析试剂盒（环孢素RIA试剂盒）进行了比较。六个中心对1320份来自接受肾脏、心脏、肝脏和骨髓移植后使用环孢素的患者的血液和血浆样本进行了分析。对于血液样本，在肾脏和骨髓移植后，使用特异性检测的中位数结果约为多克隆检测结果的50%，在心脏和肝脏移植后约为33%；血浆样本的相应数字分别为70%和40%。单克隆非特异性抗体检测产生的结果比多克隆检测结果高10%至140%，这取决于样本基质和移植指征；在心脏和肝脏移植受者的样本中差异最大。显然，特异性抗体检测为该药物的特异性测量提供了一种比高效液相色谱法更便捷的替代方法，但新的非特异性抗体与环孢素代谢物的交叉反应谱比原来的多克隆抗血清更宽，其作用尚待确定。
