酶联免疫法与微粒子酶免疫法检测全血他克莫司浓度的比较

Comparison of MEIA assay and ELISA assay for the quantificati on of tacrolimus levels in whole blood

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 MEIA assay and ELISA for the quantification of tacrolimus levels in w hole blood,and sum up its clinical application in organ transplantation.METHODS Recoveries of two methods were calculated by determining different level of tacr olimus standard in whole blood samples.The MEIA and ELISA was used to detect ta crolimus valley point concentrations in heart,liver,small intestine and kidney transplantation recipients at different postoperative periods.Based on the re sults combined with clinical findings,the dosage of tacrolimus was adjusted.RESULTS The recovery of the MEIA and ELISA were ( 96.4 ± 1.4)% and ( 104.7 ± 1 .8)% respectively.The RSD of the MEIA and ELISA were ( 7.7 ± 2.0)% and (8.2 ± 1.7)% respectively.CONCLUSIONS Both methods are suitable for TDM in hospital.