新型冠状病毒胶体金检测卡产品的性能评估  

Performance evaluation of SARS-CoV-2 colloidal gold test card products

作　　者：朱辉煌 曹中森 曹家敏 胡征 周志军[3] ZHU Hui-huang;CAO Zhong-sen;CAO Jia-min;HU Zhengg;ZHOU Zhi-jun(College of Biological Engineering and Food,Hubei University of Technology,Wuhan 430068,China;Key Laboratory of Fermentation Engineering,Ministry of Education,Wuhan 430068,China;Department of Scientific Research and Development,Sinopharm Wuhan Blood Products Co.,Ltd.,Wuhan 430207,China)

机构地区：[1]湖北工业大学生物工程与食品学院,湖北武汉430068 [2]发酵工程教育部重点实验室,湖北武汉430068 [3]国药集团武汉血液制品有限公司科研开发部,湖北武汉430207

出　　处：《生物技术》2023年第4期476-481,共6页Biotechnology

基　　金：湖北省自然科学青年基金项目(2017CFB226)。

摘　　要：[目的]参考新型冠状病毒抗原/抗体检测试剂注册技术审评要点,对新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)胶体金免疫层析检测卡的产品性能进行评估。[方法]通过双抗体制备的胶体金免疫层析检测卡,针对其检测限、特异性、稳定性等方面进行测试。[结果]检测卡产品对新型冠状病毒N蛋白的灵敏度(最低检测限)为50 ng/mL;检测10种呼吸道重要病原菌、12种病毒无阳性反应;检测结果不受内源性、外源性干扰物质的影响;试纸在室温保存1 a仍然具有良好的稳定性;且同一批次内、3个批次间稳定性良好。[结论]制备的胶体金免疫层析检测卡产品,检测22种非新型冠状病毒结果为阴性,具有较高特异性;检测结果不受25种干扰物质影响;产品批内、批间质量稳定,可在15 min内获取检测结果。产品性能指标符合评审要求,可进行临床试验验证对真病毒的特异性与灵敏性。[Objective]According to the key points of technical review for registration of severe acute respiratory syndrome coronavirus 2 antigen/antibody detection reagent,to evaluate the performance of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)colloidal gold immunochromatographic test products.[Method]The products prepared based on double antibody sandwich method were tested in terms of sensitivity,specificity and stability and other aspects.[Result]The sensitivity of the detection products to the N protein of SARS-CoV-2 was 50 ng/mL;It had no cross reaction with 10 important respiratory pathogens and 12 viruses;The detection results were not easily affected by endogenous and exogenous interfering substances;The test paper still had good stability after being stored at room temperature for one year;And the stability of the same batch and three batches was good.[Conclusion]The prepared colloidal gold immunochromatographic detection card product detected 22 non novel coronavirus with negative results and high specificity;The test results are not affected by 25 interfering substances;The quality of products within and between batches is stable,and the test results could be obtained within 15 minutes.The product performance indicators met the review requirements,and clinical tests can be conducted to verify the specificity and sensitivity to real viruses.

关 键 词：新型冠状病毒 胶体金免疫层析检测卡 灵敏度 特异性 干扰试验 稳定性 

分 类 号：R446.61[医药卫生—诊断学]