我国血站血液检测实验室检测能力基本情况分析

Analysis on testing ability of blood testing laboratories in domestic blood establishments across China

目的 分析掌握我国血站血液检测实验室(简称实验室)检测的基本现实情况,充分了解血站实验室资源配置、工作量和标本不合格情况。方法 在2020年4、7、10月及2021年1月各月的1日~15日,通过国家卫健委临床检验中心官网站指定的填报平台(https://srv.clinet.cn/qblood/report/add1.aspx),收集其中由全国各血站血液检测实验室登录后在室间质量评价系统中填写上报的2020年各季度相关质量指标[资源调查型指标、献血者检测(人)份数和献血者检测不合格数(率)]数据,由系统自动整合导出后做统计分析。结果 1)2020年324家实验室累计献血者血清学检测量1 352万9 778(人)份、核酸检测量1 389万2 927(人)份,4个季度均正确上报数据的实验室有253家、其当年检测的献血者数合计1 201万5 407(人)份。2)不同实验室间设备数量差异较大,部分实验室存在单台设备负荷过大的情况。3)酶免检测试剂的国产化比例100%(322/322),核酸检测试剂中进口试剂占比73.33%(220/300)。4)HBsAg项目的不合格率与不同地理区域的分布密切相关,其中HBsAg总不合格率四川省0.86%(5 895/689 445)、广东省0.57%(5 147/895 929)、广西壮族自治区0.53%(3 021/573 216)明显高于其他省市自治区。结论 目前我国血站数量多,规模及检测设备数量差异较大;不同地区实验室检测献血者得出的传染性指标阳性率差异明显,欲及时有效提高实验室的检测能力和质量,各地实验室需要实时开展室内纵向比较与不同实验室之间的横向比较。

Objective To analyze testing ability of blood testing laboratories in domestic blood establishments,and to comprehensively understand the resource allocation,workload and unqualified blood samples.Methods All blood testing laboratories reported the quarterly quality indicator data via their EQA system on the website of National Center for Clinical Laboratories(https://srv.clinet.cn/qblood/report/add1.aspx).We collected related quality indicators throughout 2020,including resource indicators,number of sample detection,and number(rate) of unqualified samples.All the data were integrated by EQA system.Results 1) Throughout 2020,324 blood testing laboratories reported that 13 529 778 donations were tested by immunoassays and 13 892 927 donations were tested by nucleic acid testing(NAT).Among them,253 laboratories reported the data correctly throughout four quarters,and they tested 12 015 407 donations.2) The number of equipment varied greatly among different laboratories,and a certain equipment was often overloaded in some laboratories.3) The proportion of domestic ELISA reagents was 100%(322/322),while the proportion of imported NAT reagents was 75.33%(220/300).4) The positive rate of HBsAg was closely related to geographical locations,as Sichuan(0.86%,5 895/689 445),Guangdong(0.57%,5 147/895 929),and Guangxi(0.53%,3 021/573 216) provinces demonstrated higher positive rates than that of other provincial regions.Conclusions There are many blood stations across China,with great differences in scale and equipment.There are obvious differences in the positive rates of infectious indicators in different regions.Therefore,the laboratory should make horizontal comparison with the laboratories in the same region,to improve the detection quality of the laboratory in time and effectively.