荧光定量PCR测定HBV DNA室间质评结果的回顾分析

Retrospective Analysis on Results in External Quality Assessment of HBV DNA Determination by Fluorescence Quantitation PCR

目的通过对乙型肝炎病毒核酸(HBV DNA)室间质量评价(external quality assessment,EQA)结果进行回顾分析,探讨检测可能存在的误差,为质量改进提供依据。方法选取2016～2018年上半年该实验室参加卫计委临检中心HBV DNA项目EQA的结果,采用能力验证(proficiency testing,PT)得分和Z比分数/标准差指数(standard deviation index,SDI)对数据进行统计,绘制休哈特控制图,结合室间质评质量控制规则分析EQA结果。结果 PT得分为100%,结果合格,当前性能为满意,累积性能为成功。│Z│<2.0结果满意,但休哈特图和用SDI和允许误差(allowed error,EA)表示的质控规则分析结果均提示可能存在系统误差。结论通过Z比分数SDI和选择合适的质控规则对EQA结果进行分析,可以识别HBV DNA定量检测系统存在的潜在系统误差和/或随机误差,以指导实验室进行持续质量改进。

Objective To analyze retrospectively the results of external quality assessment(EQA)of hepatitis B virus(HBV)DNA,and explore the probability of error,and provide the basis for quality improvement.Methods The results of Ministry of Health National Center for Clinical Laboratory external quality assessment for HBV DNA item from 2016to 2018were collected to analyze retrospectively by proficiency testing(PT)score,Zscore or standard deviation index(SDI),Shewhat Chart and quality control rules of EQA.Results The PT score was 100%as pass.The current performance was satisfied and the cumulative performance was success.The Zscore was<2.0as satisfaction.But the Shewhat Chart and combination quality control rules of SDI and EA demonstrated the probability of systematic error.Conclusion Zscore or SDI and quality control rules can be used to analyze EQA data,detect the potential systematic and random error existing on HBV DNA quantitative detection system,and guide the improvement of clinical laboratory quality.