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目的 :比较微粒子酶免疫法 (MEIA)和酶联免疫法 (ELISA)检测全血他克莫司浓度的特点 ,总结其在临床他克莫司全血浓度检测中的应用。方法 :分别以MEIA和ELISA平行测定高、中、低标准浓度的他克莫司血样 ,比较两种方法的准确度、精密度、相关性及各自特点。以他克莫司谷浓度测定结果结合器官移植受者的临床情况 ,比较MEIA法和ELISA法在心脏、肝脏、小肠和肾脏移植患者全血他克莫司谷浓度治疗窗的范围。结果 :MEIA和ELISA方法学的回收率分别为 (96 .4±1 .4) %和 (1 0 4.7± 1 .8) %,RSD分别为 (7.7± 2 .0 ) %和 (8.2± 1 .7) %,r =0 .96。与MEIA法相比 ,ELISA法灵敏度更高、测试成本更低 ,但分析速度较慢。MEIA和ELISA可采用相同的谷浓度治疗窗范围。结论 :两种方法均准确可靠 ,适用于临床他克莫司的治疗药物监测。
Objective: To compare the characteristics of whole blood tacrolimus by MEIA and ELISA, and to summarize its application in the detection of tacrolimus whole blood concentration in clinical practice. Methods: Tacrolimus blood samples with high, medium and low concentrations were measured in parallel with MEIA and ELISA respectively. The accuracy, precision, correlation and their characteristics of the two methods were compared. The range of tacrolimus concentration-therapeutic window in whole blood of patients with heart, liver, small intestine and kidney transplantation was compared with the results of Tacrolimus concentration combined with the clinical data of organ transplant recipients. Results: The recoveries of MEIA and ELISA methods were (96.4 ± 1.4)% and (10 4.7 ± 1.8)%, respectively, with RSDs of 7.7 ± 2.0 and 8.2 ± 1 .7)%, r = 0 .96. Compared with the MEIA method, ELISA method is more sensitive, the test cost is lower, but the analysis speed is slower. MEIA and ELISA can use the same trough concentration to treat the window. Conclusions: Both methods are accurate and reliable and are suitable for the monitoring of therapeutic drugs in clinical tacrolimus.