罗映杰 刘艳婷 肖光军

摘   要：目的  探討我科室超敏CRP检测系统室间质评偏倚较大的原因及对策。方法  将卫生部临检中心室间质评成绩回报主页中超敏CRP的临检中心数据按方法、试剂、校准物及EQA分组统计后，分别观察5个EQA样品在各组中的中位数，并与我科室检测系统所属组的中位数进行比较，并以重新分组后的中位数为靶值，分别计算我科室EQA网络回报结果和冻存样品复测结果与此靶值的bias%和正确度。结果  EQA网络回报结果与冻存样品复测的结果一致，以试剂和校准物生产厂家进行分组时，两次检测结果与中位数的bias%均<1/3TEa，正确度验证通过;而以方法和EQA分组方法分组时bias%则明显增高，虽然均1/2TEa，正确度验证未通过。结论  超敏CRP室间质评时以仪器进行分组计算靶值的方式可能不适当，建议按试剂厂家进行分组或以参考方法对EQA样品赋值后进行偏倚的评估，以正确指导临床实验室进行质量改进;同时，试剂厂家应加强校准品的溯源性及互通性，且校准品的浓度应包含不同医学决定水平处的浓度。

关键词：超敏CRP;室间质评;偏倚

中图分类号：R446.1                                   文献标识码：A                               DOI：10.3969/j.issn.1006-1959.2018.05.028

文章编号：1006-1959（2018）05-0087-04

Analysis of the Reasons and Countermeasures for the Bias of Ventricular Quality Evaluation in Hypersensitive CRP

LUO Ying-jie，LIU Yan-ting，XIAO Guang-jun

（Department of Laboratory，Suining Central Hospital，Suining 629000，Sichuan，China）

Abstract：Objective  To explore the causes and countermeasures of the bias of the room quality evaluation in the hypersensitive CRP detection system in our department.Methods  The Ministry of health clinical center of clinical laboratory data results in return home HS CRP inspection center EQA according to statistical method，reagents，calibrators and EQA packet，5 EQA samples were observed in each group of the median，and compared with the median of our department detection system belongs to the group，and median again after grouping as the target value were calculated in our department EQA network return results and frozen sample survey results and the target value and accuracy of bias%.Results  EQA network returns with the results of frozen sample survey，grouped by the reagent and calibrator manufacturer，the two test results with a median of bias%<1/3TEa，the accuracy is verified by the method;and EQA packet bias% grouping method was significantly increased，although the<TEa，there still are 3 or more samples of bias%>1/2TEa， accuracy verification failed.Conclusion  It may not be appropriate to use instruments to calculate the target values in the room quality assessment of hypersensitive CRP.It is suggested that the bias of EQA samples should be evaluated by the group of reagent manufacturers or by reference method.At the same time，the traceability and interoperability of calibration products should be strengthened by reagent manufacturers，and the concentration of calibration products should include the concentration of different medical decision levels.

Key words：Hypersensitive CRP;Ventricular quality evaluation;Bias

在实验室质量管理中，室间质量评价（EQA）越来越受到医院和临床实验室用户的重视，它是多家实验室分析同一标本并由外部独立机构收集和反馈实验室上报结果评价实验室操作的过程，可为客户、认可机构和法规部门提供实验室检测能力的客观证据，同时也是一种质量控制工具，可帮助实验室采取相应的措施提高检验质量[1]。我科室于2017年卫生部临检中心组织的第一次心肌标志物EQA活动中首次回报了超敏C-反应蛋白（CRP）的检测结果，5个EQA样品的检测结果均在所属组（Hitachi组）的允许范围内，但与靶值的相对偏倚（bias%）均较大。……