浙江地区新建新型冠状病毒核酸检测实验室质量现状分析  

Status of quality management of new laboratories for nucleic acid determination of SARS-CoV-2 in Zhejiang

作　　者：陈倩 单志明[1] 宋超[1] 康凤凤[1] 金静 郦卫星[1] CHEN Qian;SHAN Zhiming;SONG Chao;KANG Fengfeng;JIN Jing;LI Weixing(Zhejiang Center for Clinical Laboratory,Zhejiang Provincial People's Hospital,the People's Hospital Affiliated to Hangzhou Medical College,Hangzhou 310014,Zhejiang,China)

机构地区：[1]浙江省临床检验中心浙江省人民医院杭州医学院附属人民医院,浙江杭州310014

出　　处：《检验医学》2022年第7期669-673,共5页Laboratory Medicine

基　　金：浙江省科技计划项目(2019C35033);浙江省医药卫生科技计划项目(2022KY020)。

摘　　要：目的了解浙江省2020年1月后新建新型冠状病毒核酸检测实验室(简称新建实验室)质量现状,为进一步提升新型冠状病毒检测能力提供参考。方法采用现场督察与质控物考核方式对随机抽取的179家[107家新建实验室和72家2020年1月前建立的新型冠状病毒核酸检测实验室(简称原有实验室)]开展新型冠状病毒核酸检测的实验室的质量管理情况进行评价,分析不符合条款和质控物考核结果。结果新建实验室不符合条款数均值超过原有实验室;新建实验室和原有实验室在室内质控与性能验证2个条款内发生的问题所占比例均较高;新建实验室检测系统配套率为25.23%,原有实验室为75.00%;常规检测与快速检测的假阴性结果均来自新建实验室。结论室内质控和性能验证存在不足是所有实验室的共性问题,建议加强对弱阳性结果室内质控循环阈值(Ct)的有效监控,并执行正确的性能验证方案。新建实验室与原有实验室检测质量尚存在一定差距,应加强对快速检测的质量管理,强化人员技能培训。Objective To investigate the status of quality management of new severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)nucleic acid determination laboratories constructed after January 2020 in Zhejiang.Methods A total of 179 SARS-CoV-2 nucleic acid determination laboratories,including 107 new laboratories and 72 laboratories constructed before January 2020(original laboratories),were enrolled randomly to on-site inspection and sample assessment.The statistical analysis of non-conforming terms and assessment results was performed.Results The non-conforming terms of new laboratories were more than original laboratories,and the problems from new laboratories and original laboratories were mainly internal quality control and performance verification.The determination system matching rate of new laboratories was 25.23%,and that of original laboratories was 75.00%.The false negative results of routine testing and rapid testing were all from new laboratories.Conclusions Internal quality control and performance verification are common problems to all the laboratories.It should strengthen the monitoring of weak positive internal quality control cycle threshold(Ct)values and implement proper performance verification protocols.There is a quality gap between new laboratories and original laboratories.It should strengthen the quality management of rapid testing and strengthen personnel skill training.

关 键 词：新型冠状病毒 核酸检测 医学实验室 现场督查 质量管理 

分 类 号：R373.1[医药卫生—病原生物学]