我国临床实验室血清蛋白质电泳室内质量控制现状分析

Analysis on results of internal quality control for serum protein electrophoresis from 2015 to 2017 in China

目的了解2015—2017年血清蛋白质电泳室内质量控制情况。方法收集2015—2017年参加卫生部临床检验中心室间质评参评单位回报的室内质量控制信息,将变异系数(CV)与1/3TEa、1/4TEa以及基于生物学变异导出的允许不精密度(CV)性能规范进行比较,得到满足各标准实验室的比例,从而分析我国血清蛋白质电泳的室内质量控制情况。结果 80%以上的实验室不精密度都能达到1/3TEa的标准,达到1/4TEa标准的实验室比例略有降低(61.07%~83.87%);而各个项目符合生物学变异导出的允许不精密度性能规范的实验室不精密度水平差异较大。按照不同的标准统计各仪器组2017年CV的通过率,满足生物学变异导出的允许不精密度性能规范的实验室比例参差不齐。而除清蛋白的比例相对较低外(~70%),Sebia Capillarys 2组满足最低性能规范项目的比例均在80%以上;除γ球蛋白(67.31%)外,达到最佳性能规范的实验室仅占回报实验室数的不足1/3。结论各项目的室内质量控制不精密度水平满足生物学变异导出的允许不精密度性能规范还存在很大差距,各实验室应建立严格的室内质量控制程序,提高血清蛋白质电泳的精密度水平。

Objective To analyze the results of internal quality control （IQC） for serum protein electrophoresis from 2015 to 2017 in China. Methods The results of IQC reported by the laboratories which participated in external quality assessment （EQA） of National Center for Clinical Laboratories （NCCL） from 2015 to 2017 were collected, then the coefficients of variation were compared with 1/3TEa, 1/4TEa and the performance specifications based on biological variation including the optimal, appropriate and minimal allow- able imprecision. The proportions of laboratories meeting the performance specification were obtained to analyze the IQC situation of ser- um protein eleetrophoresis in China. Results More than 80% of the participant laboratories could achieve 1/3TEa standards, and 61.07% to 83.87% of the participant laboratories could achieve 1/4TEa standards. There were large differences of the levels of allowa- ble imprecision among various test items based on biological variation under the performance specifications. The acceptable rates of co- efficients of variation by the optimal, appropriate and minimal allowable imprecision based on biological variation during 2017 were var- ied between different measurement systems. More than 80% of the participant laboratories could achieve the acceptable rates by the minimal allowable imprecision based on biological variation in the group of Sebia Capillarys 2 except for albumin （ ~ 70% ）. However, only less than one third of the participant laboratories met the minimal allowable imprecision based on biological variation, except from the test for γ-globulin （67.31%）. Conclusion There is a big gap for the imprecision levels of various items in IQC, which were showed by the performance specifications based on biological variation including optimal, appropriate and minimal allowable impre- cision. Strict IQC procedures should be established in all the participant laboratories for comparison of inter-laboratory, and the preci- sion of the test for serum protein electrophoresis should be improved.