室内质量控制在EMIT法监测他克莫司血药浓度中的应用

目的:通过室内质量控制提高血药浓度监测的质量。方法:采用酶放大免疫分析技术(EMIT)法测定他克莫司血药浓度低、中、高质控品各85个点,应用Excel自动作图功能绘制质控图,对监测过程进行回顾性质量分析;分别在21、22、23、24、25℃,测定低、中、高质控品各5份,考察温度对血药浓度测定结果的影响。结果:低、中、高质控品实测值各有9、1、5个点超出质控的允许误差范围;3水平质控的RSD分别为22.6%、14.5%和12.8%;环境温度对EMIT法的监测结果有显著影响。结论:室内质量控制对于应用EMIT法监测他克莫司的血药浓度很重要,可及时预防并纠正各类误差,提高监测结果的精确性,从而对监测结果作出更精确的判断。

Application of Indoor Quality Control in Blood Concentration Monitoring of Tacrolimus by EMIT Method

OBJECTIVE：To improve the quality of blood concentration monitoring by Indoor quality control （IQC）.METHODS： Blood concentrations of tacrolimus （85 points each for low,middle and high quality control） were determined by EMIT method and the quality control graphs were drawn by Excel.The monitoring course underwent retrospective quality control.5 samples of low,middle and high quality control were determined at 21 ℃,22 ℃,23 ℃,24 ℃,25 ℃（n=5）.Effect of temperature on concentration was observed.RESULTS：The results were over the allowable error range of the low,middle and high quality control samples were 9,1,5 respectively.The RSDs of three level quality control were 22.6%,14.5% ,12.8%,respectively.The results of EMIT method were influenced by temperature especially.CONCLUSION：IQC is very important for blood concentration monitoring of tacrolimus by EMIT method.It can prevent and rectify various kinds of error and enchance the accuracy of result,which can make more accuracy estimate.