目的 分析安徽省各级疾病预防控制机构(简称疾控机构)新型冠状病毒(简称新冠病毒)核酸检测室间质量评价(EQA)结果,为提高实验室检测质量提供数据支持。方法 收集各疾控机构实验室采用实时荧光RT-PCR法检测高、中、低3种浓度新冠病毒核酸EQA样品的定性结果,计算合格率,并对检测人员、设备和试剂及Ct值进行分析。结果 安徽省疾病预防控制中心2021—2023年共组织5次全省新冠病毒核酸检测EQA,前3次EQA合格率均为100.00%,后2次EQA合格率均为99.14%。85.35%的疾控机构实验室EQA由3人共同完成检测。各级疾控机构实验室使用的实时荧光RT-PCR核酸检测试剂盒涉及15种品牌。5次EQA使用量居前5位的试剂检测新冠病毒ORF和N基因Ct值的SD值为0.80～5.60。结论 安徽省疾控机构新冠病毒核酸检测质量良好,质控品可以验证检测系统性能并有效识别实验室风险。

Objective To analyze the examination results of external quality assessment (EQA) of SARS-CoV-2 nucleic acid detection in disease prevention and control institutions at all levels in Anhui Province,so as to provide data support for improving laboratory testing quality. Methods The qualitative results of EQA samples of high,medium,and low concentrations of SARS-CoV-2 nucleic acid testing by laboratories in disease prevention and control institutions using real-time fluorescence RT-PCR method were collected,and the pass rate was calculated.The detection personnel,equipment,reagents and Ct value were analyzed. Results From 2021 to 2023,Anhui Provincial Center for Disease Control and Prevention (CDC) organized five EQA of SARS-CoV-2 nucleic acid in the whole province.The qualification rates of the first three EQAs were all 100.00%,and the qualification rates of the last two EQAs were all 99.14%.85.35% of the EQAs in CDC laboratories were jointly completed by three individuals.The real-time fluorescent RT-PCR nucleic acid detection reagents used in laboratories at all levels involved 15 brands.The SD value of SARS-CoV-2 ORF and N gene Ct value detected by the top five reagents used for five EQAs was 0.80~5.60. Conclusion The quality of SARS-CoV-2 nucleic acid detection in the disease control and prevention institutions of Anhui Province is good.Using quality control products for quality control can verify the performance of the detection system and effectively identify laboratory risks.