摘要
目的:评估三种品牌新型冠状病毒抗原洗脱液对雅培(上海)诊断产品销售有限公司生产的Clearview甲型/乙型流感病毒抗原检测盒的性能影响,探讨研究使用一个样本同时进行新型冠状病毒抗原和甲型/乙型流感病毒抗原两种检测的可行性.方法:选取江苏大学附属医院就诊的102例患者,每人采取两根鼻拭子.按照各自的产品说明书对同一患者采集的双份鼻拭子分别用所选的三种品牌中的一种新型冠状病毒抗原洗脱液和甲型/乙型流感病毒抗原洗脱液进行抗原洗脱、同时检测甲型/乙型流感病毒抗原检测,对检测的结果进行符合率分析.结果:广州万孚生物技术股份有限公司的新型冠状病毒抗原洗脱液的检测Clearview甲型/乙型流感病毒抗原的结果,甲型流感病毒抗原阳性符合率为100%;乙型流感病毒抗原阳性符合率、阴性符合率、总符合率均为100%.杭州艾康生物技术有限公司的新型冠状病毒抗原洗脱液的检测Clearview甲型/乙型流感病毒抗原的结果,甲型流感病毒抗原阳性符合率、乙型流感病毒抗原阳性符合率均为100%;阴性符合率为90%;总符合率为97%.浙江东方基因生物制品有限公司的新型冠状病毒抗原洗脱液的检测Clearview甲型/乙型流感病毒的结果,甲型流感病毒抗原阳性符合率、乙型流感病毒抗原阳性符合率、阴性符合率、总符合率均为100%.结论:所试验的三种品牌的新型冠状病毒抗原洗脱液适用于雅培(上海)诊断产品销售有限公司生产的Clearview甲型/乙型流感病毒抗原检测.
Abstract
Objective:To evaluate the performance of three brands of novel coronavirus(SARS-CoV-2)antigen eluents(product of Guangzhou Wanfu Biotechnology Co.,Ltd,Hangzhou Aikang Biotechnology Co.,Ltd and Zhejiang Dongfang Gene Biological Products Co.,Ltd)on the performance of influenza A(B)virus antigen test kits.Methods:A total of 102 patients were selected as research group.Two nasal swabs were taken for each patient.Two nasal swabs collected from the same patient were deal with one of the three selected brands of novel coronavirus antigen eluent and influenza A/B virus antigen eluent respectively.According to the respective product instructions,the influenza A/B virus antigen were detected.The coincidence rate of detection results was analyzed.Results:The detection of Clearview A/B infection in Guangzhou Wanfu Biotechnology Co.,Ltd's Novel Coronavirus eluent were that:positive coincidence rate of A infection was 100%,positive coincidence rate of B infection was 100%,negative coincidence rate was 100%,total coincidence rate was 100%.The detection of Clearview A/B infection in Hangzhou Aikang Biotechnology Co.,Ltd's Novel Coronavirus eluent were:positive coincidence rate of A infection was 100%,positive coincidence rate of B infection was 100%,negative coincidence rate was 90%,and total coincidence rate was 97%.The detection of Clearview A/B infection in Zhejiang Dongfang Gene Biological Products Co.,Ltd's Novel Coronavirus eluent were that:the positive coincidence rate of A infection,positive coincidence rate of B infection,negative coincidence rate and total coincidence rate were all 100%.Conclusion:The three tested brands of novel coronavirus antigen eluents are suitable for influenza A/B virus antigen detection produced by Abbott(Shanghai)Diagnostic Products Sales Co.,LTD.
基金项目
江苏省自然科学基金青年基金(BK20170563)
NETL
NSTL
万方数据