尿液定量生化检验项目室内质量控制变异系数调查与分析

目的 评估尿液定量生化项目的室内质量控制(internal quality control,IQC)变异系数(coefficient of variation,CV)质量水平,并为实验室提供改进建议。方法 采用基于Web的室间质量评价(external quality assessment,EQA)软件系统,收集参加全国尿液定量生化室间质评计划实验室2014年4月的IQC数据。依据1/3室间质量评价限(total allowable error,TEa)和1/4TEa对IQC不精密度进行评价,计算各实验室室内质控CV通过率。并按照是否使用配套检测系统分别统计。结果 研究中,上报尿液定量生化项目各项目IQC相关数据的实验室数量从71到111不等。不同项目的当月和累积在控CV各不相同,其中K,Na和Cl的当月在控CV通过率高达100%,质量水平较高。Mg,Cre,Urea和mAlb则相对较低(75.68%～93.51%),需要改进。不同实验室各项目使用仪器、试剂、校准品的配套情况各不相同,配套检测系统累积CV中位数大于不配套检测系统。结论 不同实验室不同项目的CV情况各不相同,实验室应该根据自身的情况选择适当的允许不精密度质量规范,将注意力更多地投入到CV不合格的项目中,不断地提升自己,这样才能提供更加准确的结果和更加优质的服务。

Investigation and Analysis of the Coefficient of Variationof Internal Quality Control of Quantitative Urine Chemistry

Objective To evaluate the coefficient of variation(CV)of internal quality control(IQC)of quantitative urine chemistry and provide suggestions for improvement accordingly.Methods Web-based External Quality Assessment(EQA)system was used to collect IQC data of quantitative urine chemistry from EQA participant laboratories in April 2014.The precision of IQC were evaluated and percentages of laboratories meetingthe quality requirement were calculated according to 1/3 total allowable error(TEa)and 1/4TEa.And further analysis was done based on whether a complete set of measurement system was used.Results The number of participant laboratories in their survey ranged from 71 to 111.Current and accumulate CV varied among different analytes.The passing rates of current CVsfor K,Na and Cl were 100% while the passing rate of Mg,Cre,Urea and mAlb wererelatively low(75.68%～93.51%)which means improvement was needed for these analytes.The situation on whether a complete set of measurement system was usedvaried among laboratories.The cumulative median CV obtained by laboratoriesemploying a complete set of measurement system was lower than those not.Conclusion The imprecision of IQC of quantitative urine chemistry varied among different laboratories and different analytes.Laboratories should set proper quality requirements and make unremitting efforts to improve quality,especially for analytes which couldn't fulfill performance goals.Only inthis way,a more accurate result and high quality service can be obtained.