三种他克莫司测定试剂盒测定移植病人全血中他克莫司浓度的比较

Comparison of three kits in concentration determination of tacrolimus in whole blood of transplant patients

目的:比较国产他克莫司测定试剂盒(微粒子酶联免疫法检测法,MEIA)、进口他克莫司测定试剂盒(微粒子酶联免疫法检测法,MEIA)以及进口他克莫司测定试剂盒(化学发光微粒子免疫法,CMIA)在检测移植病人全血中他克莫司血药浓度时的异同与相关性。方法:用国产和进口他克莫司测定试剂盒(微粒子酶联免疫法检测法,MEIA)分别测定147例移植后服用他克莫司的病人全血样品,用进口他克莫司测定试剂盒(化学发光微粒子免疫法,CMIA)测定其中49例样品,对检测结果进行统计学分析,考察三种试剂盒的等效性与相关性。结果:三种方法中任意两种方法的检测结果用配对t检验进行检测,均无显著差异,用Ex-cell进行相关性分析,其相关系数均大于0.9,相关性好。结论:三种试剂盒均可用于他克莫司的血药浓度检测,且相关性高。

Objective：To compare the ability of detecting blood concentration of tacrolimus in transplant patients with three assay kits ： a domestic tacrolimus assay kit （ mieroparticle enzyme - linked immunosorbent assay, MEIA）, an imported IMx tacrolimus II Reagent pack （microparticle enzyme - linked immunosorbent assay, MEIA） , and another imported tacrolimus Division assay kit （chemilumineseent microparticle immunoassay, CMIA）. Methods： By using the domestic tacrolimus kit （MEIA） and the imported IMx tacrolimus II Reagent （MEIA） after transplanta- tion, the tacrolimus blood concentration was detected in the whole blood samples of 147 patients with organ transplantation. And the comparison of the domestic tacrolimus kit （MEIA） and another imported taerolimus assay kit （CMIA） was conducted in 49 patients. The test results were statistically analyzed to study the equivalence and relevance of three types of kits. Results： The detection results of any two kits had no significant difference by paired t test. With Excell for correlation analysis, the correlation coefficients were greater than 0.9, showing good correlation. Conclusion： All three kits can be used for taerolimus blood concentration detection, showing high correlation in the test results.