全国甲型流感病毒核酸检测室间质量评价  

Nationwide external quality assessment for nucleic acid detection of influenza A virus

作　　者：赵梓弘 马樱硕 韩彦熙 李金明[2] 张瑞 ZHAO Zihong;MA Yingshuo;HAN Yanxi;LI Jinming;ZHANG Rui(Peking Uniersity Fifih School of Clinical Medicine,Beijing 100730;National Center for Clinical Laboratories,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Hospital/National Center of Gerontology,Beijing 100730,China)

机构地区：[1]北京大学第五临床医学院,北京100730 [2]北京医院国家老年医学中心,国家卫生健康委临床检验中心,中国医学科学院老年医学研究院,北京100730

出　　处：《临床检验杂志》2025年第2期115-119,共5页Chinese Journal of Clinical Laboratory Science

基　　金：国家重点研发计划(2022YFC2603800)。

摘　　要：目的了解我国临床实验室对甲型流感病毒核酸检测能力的总体情况,发现潜在问题以进一步提高检测质量。方法国家卫生健康委临床检验中心2024年共发放5份样本至1367家参评实验室。通过计算各参评实验室和使用不同试剂的实验室检测结果的符合率,评估其检测能力。结果样本总符合率为99.87%(6826/6835),阳性样本符合率为99.89%(5462/5468),阴性样本符合率为99.78%(1364/1367)。不同浓度的H3N2病毒样本、同等浓度水平(1.0×10^(4)拷贝/mL)的H1N1(2009)和H3N2病毒样本以及同等浓度水平(1.0×10^(5)拷贝/mL)的季节性H1N1和H3N2病毒样本,实验室检测的阳性符合率差异均未见统计学意义(P均>0.05)。结论我国临床实验室对甲型流感病毒H1N1(2009)和H3N2两种常见亚型检出能力较为理想,少数实验室存在假阴性和假阳性结果问题。Objective To understand and evaluate the overall status of nucleic acid detection efficacy for influenza A virus in the nationwide clinical laboratories of China,and discover and identify the potential issues to further improve the detection quality.Methods During 2024,the National Center for Clinical Laboratories distributed five samples to nationwide 1367 participating laboratories.The detection efficacy of each participating laboratory was evaluated by calculating the overall percent agreement(OPA)of the test results using different detection reagents.Results The results of OPA,positive percent agreement(PPA)and negative percent agreement(NPA)of the five samples were 99.87%(6826/6835),99.89%(5462/5468),and 99.78%(1364/1367),respectively.No statistical difference of PPAs was observed between the H3N2 samples with different concentrations,between H1N1(2009)and H3N2 samples with equivalent concentration(1.0×10^(4)copies/mL),and between seasonal H1N1 and H3N2 samples with equivalent concentration(1.0×10^(5)copies/mL)(P>0.05).Conclusion The results indicated the clinical laboratories in China exhibited robust fficacy in the molecular detection for two prevalent influenza A virus subtypes,i.e.,H1N1(2009)and H3N2.However,false-negative and false-positive results were encountered in a few laboratories.

关 键 词：甲型流感病毒 核酸检测 室间质量评价 公共卫生 

分 类 号：R446.5[医药卫生—诊断学]