血站实验室ELISA检测质量监测指标的应用与分析

Application and analysis of enzyme immunoassay quality monitoring indicators in blood station laboratories

目的以抗-HIV ELISA检测为例,应用实验室质量监测指标对实验室检测质量进行评估,持续提高实验室检测能力。方法对本中心血液检测实验室2020年7月1日-2022年12月31日的检测数据应用实验室质量监测指标(初试反应数、初试反应率、复试反应数和复检符合率)进行分析,统计上述时间段内2种抗-HIV ELISA试剂(新创和万泰)室内质控数据,绘制成折线图或散点箱型图,监控长期变化趋势并查找原因。和同期国家卫健委临检中心,全国血站血液检测实验室质量监测指标评价报告的数据进行实验室间能力比对和评价。结果2020年7月1日-2022年12月31日,新创和万泰抗-HIV ELISA试剂的初试反应率分别为0.052%和0.080%(P<0.05),复检符合率分别为43.97%和73.39%(P<0.05)。新创试剂复检符合率的线性均值趋势与全国同组复检符合率均值接近,万泰试剂复检符合率高于全国同组试剂复检符合率均值。2种试剂的试剂使用率均低于全国同组试剂使用平均值。新创试剂不同批次间室内质控均值离散程度大于万泰试剂,但2者不同批次试剂间室内质控CV离散程度相似。结论通过实验室质量监测指标对本实验室长期检测数据的纵向分析,和对全国同试剂实验室进行横向比较。能及时发现实验室存在的问题,采取纠正措施,从而对实验室质量管理体系进行持续改进,进一步提升实验室的检测能力。

Objective To evaluate the quality of laboratory testing using anti-HIV ELISA quality monitoring indicators and continuously improve laboratory testing capabilities.Methods The data of our blood testing laboratory from July 1,2020 to December 31,2022 using laboratory quality monitoring indicators were analyzed,including the reaction sample size and reaction rate of initial test and the reaction sample size and compliance rate of retest.The indoor quality control data of two anti HIV ELISA reagents(Xinchuang and Wantai)during the above time period were collected.A line chart or scatter box chart was drawn to monitor the long-term trends and identify the reasons.Inter-laboratory capability comparison and evaluation with the data from the quality monitoring index evaluation report of the National Health Commission′s Clinical Inspection Center and the National Blood Station Blood Testing Laboratory during the same period was conducted.Results From July 1,2020 to December 31,2022,the initial reaction rates of Xinchuang and Wantai anti HIV ELISA reagents were 0.052%and 0.080%,respectively(P<0.05),and the retest compliance rates were 43.97%and 73.39%,respectively(P<0.001).The linear mean trend of the retest compliance rate of innovative reagents is close to the national average retest compliance rate of the same group,while the retest compliance rate of Wantai reagents is higher than the national average retest compliance rate of the same group reagents.The usage rates of the two reagents are lower than the national average for the same group of reagents.The average dispersion of indoor quality control values between different batches of innovative reagents is greater than that of Wantai reagents,but the dispersion of indoor quality control CV between different batches of reagents is similar.Conclusion Longitudinal analysis of long-term testing data in our laboratory through laboratory quality monitoring indicators and horizontal comparison of laboratories with the same reagents nationwide are able to promptly identify problems in the laboratory,therefore help correct the problems and continuously improve the laboratory′s quality management system,further enhancing the laboratory′s testing capabilities.