SARS-CoV-2抗原快速检测卡对不同病毒株的灵敏度评价  

Evaluation of sensitivity of SARS-CoV-2 antigen-detecting rapid diagnostic cards to different strains

作　　者：施金荣 周志军 冯璐 岳胜兰 程小玲 张雪婷 胡勇 段凯 李策生 SHI Jinrong;ZHOU Zhijun;FENG Lu;YUE Shenglan;CHENG Xiaoling;ZHANG Xueting;HU Yong;DUAN Kai;LI Cesheng(Wuhan Institute of Biological Products Co.,Ltd.,Wuhan 430207,Hubei Province,China;不详)

机构地区：[1]武汉生物制品研究所有限责任公司,湖北武汉430207 [2]国药集团武汉血液制品有限公司,湖北武汉430207

出　　处：《中国生物制品学杂志》2023年第6期680-686,共7页Chinese Journal of Biologicals

基　　金：国家科技部重点专项(2020YFC0841800)。

摘　　要：目的比较国内外严重急性呼吸综合征冠状病毒2(severe acute respiratory symptom coronavirus 2,SARS-CoV-2)抗原快速检测卡检测不同病毒株的灵敏度(稀释度)。方法以武汉生物制品研究所有限责任公司(以下简称武汉所)提供的4种SARS-CoV-2病毒株[原始株、贝塔(Beta)变异株、德尔塔(Delta)变异株和奥米克戎(Omicron)变异株]疫苗原液作为灵敏度评估用样品盘,用国内外17个厂家的21批次SARS-CoV-2抗原快速检测卡及上海捷诺生物科技有限公司生产的SARS-CoV-2核酸检测卡分别检测4种疫苗原液的系列稀释样本,根据稀释度评价抗原快速检测卡和核酸检测试剂的灵敏度。并将抗原快速检测卡与核酸检测卡检测结果进行比较,判断稀释度最大即灵敏度最高1组抗原快速检测卡对应的核酸检测Ct值。结果检测原始株、Beta株、Delta株和Omicron株疫苗原液,抗原检测卡的灵敏度分别为1∶10~1∶8×10^(4)、1∶10^(3)~1∶2×10^(5)、1∶10^(2)~1∶4×10^(4)和1∶10~1∶4×10^(5);核酸检测试剂的灵敏度分别为10^(-6)、10^(-5)、10^(-4)和10^(-7)。高灵敏度的抗原快速检测卡能达到核酸检测的N基因的Ct值分别为原始株(10^(-4))>31、Beta株(10^(-5))>36、Delta株(10^(-4))>34、Omicron株(10^(-5))>33,达到国内与欧盟对SARS-CoV-2抗原快速检测试剂的要求。结论所有抗原快速检测卡均能检出4种病毒株,但不同试剂检测不同病毒株的灵敏度存在一定差异,其中对Omicron株的灵敏度相对差异最大。Objective To compare the sensitivity(dilution)of antigen-detecting rapid diagnostic cards for severe acute respiratory symptom coronavirus 2(SARS-CoV-2)at home and abroad to different strains.Methods Vaccine bulks of four SARS-CoV-2 strains(original strain,Beta,Delta and Omicron)produced by Wuhan Institute of Biological Products Co.,Ltd.were used as the sample panel for sensitivity assessment,of which a series of diluted samples were detected by using 21 batches of SARS-CoV-2 antigen-detecting rapid diagnostic cards from 17 domestic and foreign manufacturers and SARS-CoV-2 nucleic acid detection reagent from Shanghai GeneoDx Biotech Co.,Ltd,respectively.The sensitivity of antigendetecting rapid diagnostic cards and nucleic acid detection reagent was evaluated according to the dilutions.The results of SARS-CoV-2 antigen-detecting rapid diagnostic reagents and nucleic acid detection reagent were compared to determine the nucleic acid detection Ct value corresponding to the group of antigen-detecting rapid diagnostic reagent with the highest dilution,namely the highest sensitivity.Results The sensitivity of antigen detection cards for the vaccine bulks of original strain,Beta,Delta and 0micron was 1:10~1:8×10^(4),1:10^(3)~1:2×10^(5),1:10^(2)~1:4×10^(4),and1:10~1:4×10^(5),respectively;The sensitivity of nucleic acid detection cards was 10^(-6),10^(-5),10^(-4)and 10^(-7),respectively.The Ct values of N gene which were reached by high sensitivity antigen-detecting rapid diagnostic cards were as follows:original strain(10^(-4))of more than 31,Beta variant(10^(-5))of more than 36,Delta variant(10^(-4))of more than 34,Omicron variant(10^(-5))of more than 33,meeting the requirements of domestic and European Union for SARS-CoV-2 antigen-detecting rapid diagnostic cards.Conclusion All the antigen-detecting rapid diagnostic cards detected the four virus strains,while the sensitivity of different reagents to different variants varies to some extent,among which the sensitivity to Omicron variant varies the most.

关 键 词：抗原快速检测卡 严重急性呼吸综合征冠状病毒2 病毒株 灵敏度 

分 类 号：R18[医药卫生—流行病学] R446[医药卫生—公共卫生与预防医学]