2014年2月全国全血治疗药物监测的室内质量控制结果分析

Analysis of the imprecision of internal quality control of therapeutic drug monitoring in whole blood in China,February,2014

目的 调查全血治疗药物监测（环孢霉素A、他克莫司、西罗莫司）室内质量控制的精密度现状。方法 用基于英特网方式的室间质量评价软件系统收集参加2014年2月全国全血治疗药物监测室间质量评价的179家实验室的室内质量控制数据,用Excel 2007和SPSS 13.0对数据进行分析,并计算允许总误差（TEa）、1/3TEa和1/4Tea这3个项目的室内质量控制变异系数的通过率。结果 最终分别有116家、108家和21家实验室回报了环孢霉素A、他克莫司、西罗莫司批号1的室内质量控制数据,59家、56家和4家回报了环孢霉素A、他克莫司、西罗莫司批号2的室内质量控制数据。约半数实验室（40.7%~57.1%）用伯乐检测系统。西罗莫司室内质量控制变异系数除累积1/4TEa的通过率在项目间差异有统计学意义外（P〈0.05）,其余情况不同项目间的通过率差异无统计学意义（P〉0.05）。环孢霉素A各检测系统室内质量控制变异系数的通过率差异无统计学意义（P〉0.05）。他克莫司除累积室内质量控制不精密度在1/4TEa评价标准时的通过率不同检测系统间差异无统计学意义外（P〉0.05）,其他3种情况差异均有统计学意义（P〈0.01）。结论 西罗莫司是室内质量控制变异系数通过率最高的检验项目,环孢霉素A不存在不同检测系统间室内质控变异系数通过率的差异,而他克莫司存在。通过对当月和累积的室内质量控制数据的变异系数的监测,并将室内质量控制数据计算的变异系数与相关要求进行比较,可以评价该检测系统的不精密度水平是否满足规定的质量要求。

Objective To investigate the coefficient of variations （CV） of internal quality control （IQC） of therapeutic drug monitoring in whole blood （cyclosporine A, tacrolimus, sirolimus）, and compare with the quality specification derived from allowable total error （TEa）. Methods Data had been collected by web- based submission system, the labo- ratories which enrolled in 2014 therapeutic drug monitoring in whole blood external quality assessment （EQA） program had attended. The da- ta was included： the CV of February of 2014 and long- term cumulative data, method and instrument, etc. Microsoft Excel 2007 and SPSS 13.0 had been used to analyze the data. The evaluation standard of EQA was considered as TEa （25%）, 1/3TEa （8.33%） and 1/4TEa were deter- mined to be the evaluation standard of CV of IQC. Results The 116,108 and 21 laboratories reported effective results of lot 1 of IQC material of cyclosporine A, tacrolimus and sirolimus, respectively while 59, 56 and 4 of lot 2. About half laboratories used Bio - Rad measurement system （40. 7 % -57.1% ）. There was no significant difference （P 〉 0.05 ） of the acceptable rate of CV between test items except accumulative CV evaluated by 1/4TEa （P 〈0.05 ）. There was no significant difference of the acceptable rate of CV between different measurement systems for cyclosporine A （ P 〉 0. 05 ）. There was significant difference between different measurement systems for （P 〈 0.01 ） tacrolimus except accumulative CV evaluated by 1/4TEa （P 〉 0. 05）. Conclusion The acceptable rates of sirolimus were higher than cyclosporine A and tacrolimus. There was no signifi- cant difference of the acceptable rate of CV between different measurement systems for cyclosporine A but not for tacrolimus. It is an effective method for clinical laboratories to improve test quality by monitoring the current and cumu- lative CV of IQC and comparing them against proper evaluation criteria to evaluate if the analysis system can meet specific quality requirements or technical specification.