量子点荧光免疫技术定量检测新型冠状病毒(SARS-CoV-2)S1抗原试剂盒的研制及性能评价  

Preparation and Performance Evaluation on Novel Corona Virus(SARS-CoV-2) S1 Antigen Quantum Dots Fluorescence Immunoassay Reagent

作　　者：李捷 刘浩 韩建勋 侯卫静 孙兆增 富玉 杨柏崇 施祖灏 LI Jie;LIU Hao;HAN Jian-xun;HOU Wei-jing;SUN Zhao-zeng;FU Yu;YANG Bai-chong;SHI Zu-hao(Pony Testing International Group Co.Ltd,Beijing 100095,China;Pony Testing International Group Beijing Academy of Inspection and Certification Co.Ltd,Beijing 100095,China;Pony Testing International Group Jiangsu Co.Ltd,Jiangsu Suzhou 215002,China)

机构地区：[1]谱尼测试集团股份有限公司,北京100095 [2]谱尼测试集团北京检验认证科学研究院有限公司,北京100095 [3]谱尼测试集团江苏有限公司,江苏苏州215002

出　　处：《现代检验医学杂志》2022年第2期148-152,共5页Journal of Modern Laboratory Medicine

基　　金：2020年苏州市新型冠状病毒感染应急防治专项,项目批号:XG56;“科技助力经济2020”重点专项,项目批号:SQ2020YFF0414333。

摘　　要：目的 建立一种基于量子点荧光免疫技术定量检测新型冠状病毒抗原的方法,并进行方法的性能验证。方法 利用新型冠状病毒的S1抗原对新型冠状病毒抗原量子点荧光免疫检测试剂盒的线性范围、精密度、准确度、最低检出限及对抗原的包容性等性能进行初步评价,判断试剂盒是否能够满足要求。结果 对实验数据进行统计分析,方法线性范围为24~25 000 pg/ml(相关系数r> 0.99);最低检出限为16.96 pg/ml;高、低浓度样本的批内精密度最大为9.65%,批间精密度为9.24%;根据相对偏差数值验证方法的准确度,结果均小于5%;通过测试不同来源的抗原,发现方法具有较高的包容性。结论 建立的快速检测新型冠状病毒抗原的方法灵敏度高、精密度好、线性范围广,在临床上具有应用前景。Objective To detect novel corona virus(SARS-CoV-2) antigen, a method based on quantum dots fluorescence immunoassay was developed. Methods For determining the performance of the method, it was evaluated the characteristics of the linear range, precision, accuracy, minimum detection limit and tolerance to antigens by using S1 antigen. Results The linear range of the method was 24~25 000 pg/ml(the correlation coeffcient r > 0.99). The minimum detection limit was 16.96 pg/ml. For high and low concentration samples, the precision of maximum intra-assay was 9.65%, and the inter-assay precision was 9.24%. The accuracy was verified by relative deviation, and the results were less than 5%. Furthermore, the product had high tolerance to antigens from different sources. Conclusion A method was provided in this study to detect the SARS-CoV-2 antigen, which have a high sensitivity, good precision and wide linear range. It is suitable for clinical application.

关 键 词：新型冠状病毒 量子点荧光免疫层析 性能验证 

分 类 号：R373.19[医药卫生—病原生物学] R392-33[医药卫生—基础医学]