摘要
目的 对4种市售国产SARS-CoV-2抗原检测试剂进行分析比较,为SARS-CoV-2抗原检测提供参考。方法 选择4种市售国产SARS-CoV-2抗原检测试剂盒,分别为试剂A、B、C和D,对54份新型冠状病毒肺炎(COVID-19)病例呼吸道样本进行抗原检测,以实时荧光聚合酶链式反应(Real-time PCR,RT-PCR)检测结果为标准。结果 54份COVID-19病例呼吸道样本,48份为阳性样本,1份为ORF1ab单靶标阳性,3份为N单靶标阳性,2份为阴性。4种抗原检测试剂的阳性率分别为试剂A 56.25%、试剂B 58.33%、试剂C 60.42%及试剂D 58.33%,阳性检出率差异无统计学意义(χ^(2)=0.171,P=0.982)。4种抗原检测试剂检测结果一致性从高到低依次为:试剂B和试剂D>试剂A和试剂B=试剂A和试剂D>试剂B和试剂C>试剂A和试剂C。结论 4种抗原检测试剂的一致性较高,对CT值低于25的样本阳性检出率达64.29%~93.33%,而CT值高于30的样本阳性检出率很低,提示试剂厂家需进一步优化性能,提高检测灵敏度。试剂C为荧光免疫层析法,需要配套使用荧光免疫分析仪,不便于普通群众使用。
Objective To provide reference for SARS-COV-2 antigen detection,four kinds of domestic SARS-COV-2 antigen detection reagents were analyzed and compared.Methods Four domestic SARSCoV-2 antigen detection kits were selected,54 respiratory tract samples were tested for antigen using the reagent A,reagent B,reagent C and reagent D.Results of Real-time PCR,RT-PCR were adopted as the standard.Results The 54 respiratory tract samples comprised 48 positive samples,one was positive for ORF1ab-single target samples,three were positive for N-single target samples and two were negative samples.The positive rates for the A,B,C and D reagents were56.25%,58.33%,60.42% and 58.33%,respectively.And there was no statistically significant difference in positive detection rate among four reagents (χ^(2)=0.171,P=0.982).The consistency of test results of the four antigen detection reagents from high to low was reagent B and reagent D>reagent A and reagent B= reagent A and reagent D>reagent B and reagent C>reagent A and reagent C.Conclusions A high consistency was performed in four antigen reagents.The positive rates of CT30 were very low.The reagent performance should be further optimized to improve detection sensitivity.Reagent C is not convenient for ordinary use,for it is detected by fluorescence immunochromatography which requires fluorescence immunoanalyzer.
作者
徐朝花
刘丽
杨慧萍
马小珍
XU Chaohua;LIU Li;YANG Huiping;MA Xiaozhen(Sichuan Center for Disease Control and Prevention,Chengdu 610041,Sichuan Province,China)
出处
《预防医学情报杂志》
CAS
2023年第2期213-218,共6页
Journal of Preventive Medicine Information
基金
四川省医学科技项目(项目编号:22ZDCX002)。
