新生儿血红蛋白病血斑筛查实验室室间质量调查结果分析

摘要

Objective To evaluate the results of 2017 external quality assessment for newborn hemoglobinopathyand improve the quality of disease screening .Methods Each of 26 participating laboratories testing newborn hemoglobinopathy across the country received 5 batches of quality control blood spots ( Lot 201711-201715 ) in octorber 2017.Laboratories voluntarily participated in the survey and reported the results, methods, equipments and reagents information .Clinet EQA, and Microsoft Excel 2010 were used to perform statistical analysis on the laboratory test results .The rates of accuracy ( number of correct results/total number of submitted results ) were used for evaluating the performance of laboratories . Results 24 laboratories submitted the testing results with a return rate of 80.8%(21/26).The rates of accuracy for each lot were 100%(21/21), 90.5%(19/21), 90.5%(19/21), 57.1%(12/21) and 100%(21/21 ) respectively.Conclusions The results of this external quality assessment for newborn hemoglobinopathy is generally satisfactory , except for HbBarts′and HbA2.The screening laboratories should improve their quality control system , take timely measures to correct mistakes during the analytic period and improve the accuracy of screening tests for newborn hemoglobinopathy.%目的 分析评价2017年新生儿血红蛋白病血斑筛查室间质量调查结果,以改进和提高血红蛋白病筛查质量.方法 2017年10月向全国26家开展新生儿新生儿血红蛋白病血斑筛查实验室发放5个批号质控血片(批号201711-201715).实验室自愿参加此次调查活动,并按照规定格式上报结果、测定方法、仪器和试剂等相关信息.组织者采用Clinet EQA程序和Microsoft Excel 2010等软件对各实验室检测结果进行统计分析,对质控样本的结果采用正确率(回报结果正确实验室数/参加该项目检测实验室总数)进行描述性评价.结果 有21家实验室回报了结果,回报率为80.8%(21/26). 5个批号中,临床判断结果的正确率为100%(21/21)、90.5%(19/21)、90.5%(19/21)、57.1%(12/21)和100%(21/21).结论 本次新生儿血红蛋白病血斑检测室间质量调查结果总体上是满意的,仅HbBart′s和HbA2部分批号存在与预期不符合的结果.筛查实验室应加强实验室质量控制意识,及时采取措施纠正检测过程中出现的偏差和错误,提高我国新生儿血红蛋白病血斑筛查结果的准确度.