包被抗原种类对抗新型冠状病毒抗体胶体金测试卡检测质量的影响  

Effect of coated antigen types on quality of anti-2019 novel coronavirus antibody colloidal gold test cassettes

作　　者：胡勇 周志军 岳胜兰 冯璐 林连珍 梅宇 谢勇 周东波 何彦林 李陶敬 李策生 Hu Yong;Zhou Zhijun;Yue Shenglan;Feng Lu;Lin Lianzhen;Mei Yu;Xie Yong;Zhou Dongbo;He Yanlin;Li Taojing;Li Cesheng(Research&Development Department,Sinopharm Wuhan Plasma-derived Biotherapies Co.,Ltd.,Wuhan 430207,China;Research&Development Center,Beijing Tiantan Biological Products Co.,Ltd.,Beijing 100024,China)

机构地区：[1]国药集团武汉血液制品有限公司科研开发部,430207 [2]北京天坛生物制品股份有限公司研发中心,100024

出　　处：《国际生物制品学杂志》2021年第3期129-132,共4页International Journal of Biologicals

基　　金：国家科技部重点专项(2020YFC0841800)。

摘　　要：目的考察包被不同种类的胶体金标记(金标)抗原对抗新型冠状病毒(2019 novel coronavirus,2019-nCoV)抗体快速检测测试卡检测质量的影响。方法采用抗2019-nCoV抗体样本盘检测厂家L包被有不同金标抗原的胶体金测试卡,比较产品的灵敏度、特异度、准确度和正确指数,暂时以准确度>95%、正确指数>0.85为合格标准。结果厂家L的6个批次分别包被有重组2019-nCoV的刺突(spike,S)+核衣壳(nucleocapsid,N)蛋白(L002)、受体结合域(receptor-binding domain,RBD)+N蛋白(L003)、N蛋白(L004)、RBD蛋白(L006)、S蛋白(L007)、N+S蛋白(L008)的测试卡,检测IgG的准确度/正确指数分别为98.38%/0.966、97.30%/0.946、97.84%/0.954、90.82%/0.873、97.86%/0.958、95.72%/0.919;检测IgM的准确度/正确指数分别为90.51%/0.736、95.57%/0.890、73.10%/0.298、68.37%/0.331、83.96%/0.533、87.17%/0.658。结论所有金标抗原包被的测试卡检测IgG均合格,只有RBD与N蛋白组合的包被金标抗原测试卡检测IgM合格,通过优化包被的金标抗原种类可提高测试卡检测IgM的质量。Objective To investigate the effect of different types of coated gold-labeled antigens on the quality of anti-2019 novel coronavirus(2019-nCoV)antibody rapid detection test cassettes.Methods An anti-2019-nCoV antibody sample panel was used to test colloidal gold test cassettes coated with different gold-labeled antigens from manufacturer L.The sensitivity,specificity,accuracy and correctness index of the product were compared.For the time being,the eligibility standard was set at accuracy>95%and correctness index>0.85.Results For the 6 batches of test cassettes from manufacturer L coated with recombinant 2019-nCoV spike(S)+nucleocapsid(N)proteins(L002),receptor-binding domain(RBD)+N proteins(L003),N protein(L004),RBD protein(L006),S protein(L007),N+S proteins(L008),the accuracies/correctness indexes of detecting IgG were 98.38%/0.966,97.30%/0.946,97.84%/0.954,90.82%/0.873,97.86%/0.958,95.72%/0.919,respectively,and those of detecting IgM were 90.51%/0.736,95.57%/0.890,73.10%/0.298,68.37%/0.331,83.96%/0.533,87.17%/0.658,respectively.Conclusions Test cassettes coated with all kinds of gold-labeled antigens are qualified for IgG detection,but only the combination of RBD and N proteins coated test cassette is qualified for IgM detection.The quality of IgM detection can be improved by optimizing the types of gold-labeled antigens coated.

关 键 词：胶体金测试卡 新型冠状病毒 免疫球蛋白M 免疫球蛋白G 准确度 正确指数 

分 类 号：R446[医药卫生—诊断学]