西格玛性能验证图在色谱法血清药物浓度检测项目中的评价和应用

The evaluation and application of the sigma performance verification chart in the serum drug concentration detection items

目的:应用六西格玛(6σ)的质量管理方法分析色谱法血清药物浓度检测项目的质量控制数据,监测并管理液相室内质量控制数据,改进血清药物浓度检测项目的质量水平。方法:收集2016年1月-2017年12月超高效液相色谱仪室内质量控制数据,依据中华人民共和国国家标准(GB/T20470-2006)-临床实验室室间质量评价要求,参照其他抗癫痫药物的可接受性能准则,计算奥卡西平、左乙拉西坦和拉莫三嗪3个项目的偏差(bias)、变异系数(CV)和西格玛(σ)值,结合标准化6σ性能决定图,评价检验项目分析性能,并计算检验项目的质量目标指数(QGI),查找导致性能不佳的主要原因并提出改进方法。结果:2016年1月-2016年12月使用Waters超高效液相色谱仪测定奥卡西平、左乙拉西坦和拉莫三嗪血药浓度检测项目的σ均值分别为3.19,2.75和2.91。3个检测项目的性能均未达到6σ水平,均需优先改进精密度。2017年度通过对Waters超高效液相色谱仪实施全面保养、校准及重新培训操作人员等措施后发现:奥卡西平中浓度、左乙拉西坦的低浓度、拉莫三嗪的低浓度和中浓度的不精密度均明显提高。结论:6σ质量管理方法可以有效地应用于Waters超高效液相色谱仪血清药物浓度检测项目的质量管理,有助于提高抗癫痫药物血药浓度监测项目的质量水平。

OBJECTIVE To apply 6σquality management method to analyze the ultra high performance liquid chromatograph data for quality control,monitor and manage the liquid indoor quality control data,and improve the quality of clinical laboratory testing items.METHODS Ultra high performance liquid chromatograph indoor quality control data were collected between January 2016 and December 2016.Based on national standard（GB/T20470-2006）of the People’s Republic of China-quality evaluation between clinical laboratory room,with reference to acceptable performance criteria of other antiepileptic drugs,three items of deviation（bias）,coefficient of variation（CV）and sigma（σ）values were calculated for oxcarbazepine,levetiracetam and lamotrigine.Standardized 6 sigma performance decision diagram was combined to evaluate analysis performance of test items,and calculate the inspection items of quality target index（QGI）,find out the main causes of poor performance and propose improvement methods.RESULTS From January 2016 to December 2016,the meanσvalues of concentrations of octazepine,levyracetam,and lamotrigine were measured by the Waters ultra high performance liquid chromatograph,which were3.19,2.75 and 2.91,respectively.The performance of the three test items was not up to the level of 6σ,priority should be given to improving the precision.Through comprehensive maintenance,calibration and retraining for Waters ultra high performance liquid chromatograph in 2017,precisions were improved for octazepine at medium concentration,levyracetam at low concentration,and lamotrigine at low and medium concentrations.CONCLUSION The quality management method of 6σcan be effectively applied to the quality management of Waters ultra high performance liquid chromatograph,which can improve the quality level of antiepileptic drug concentration monitoring items.