Establishment and application of national reference panels for SARS-CoV-2 antigen detection kit  

作　　者：Tingting Ma Donglai Liu Keliang Lyu Tingting Gao Dawei Shi Lanqing Zhao Shu Shen Yabin Tian Sihong Xu Haiwei Zhou 

机构地区：[1]Division II of In Vitro Diagnostics for Infectious Diseases,Institute for In Vitro Diagnostics Control National Institutes for Food and Drug Control,Beijing 100050,China [2]School of Life Sciences and Medicine,Shandong University of Technology,Zibo 255049,China

出　　处：《Biosafety and Health》2023年第6期326-330,共5页生物安全与健康（英文）

基　　金：supported by the National Key Research and Development Program of China (2021YFC2400904);the National Science and Technology Major Project of China (2018ZX10102001).

摘　　要：To develop a national reference panel for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen detection kit and establish a quality standard.The cultures of SARS-CoV-2 and other pathogens were collected to establish a national reference panel for SARS-CoV-2 antigen detection.The stability and homogeneity of the reference panel were evaluated.Based on World Health Organization(WHO)guidance and nucleic acid quantitative results,a quality standard reference panel was established.Currently,three generations of SARS-CoV-2 antigen national reference materials with batch numbers 370095–202001,370095–202202,and 370095–202203 have been successfully established.These national reference panels comprised 8 positive samples,20 negative samples,1 repetitive sample,and 1 lower detection limit sample.The stability and homogeneity of the reference panel meet the requirements.The quality standards are as follows:the positive and negative coincidence rates are 8/8 and 20/20,respectively.The 10 test results of the medium and low-concentration repetitive reference materials should be positive,and the color rendering should be uniform(or the coefficient of variance should not be higher than 20.0%).The lower detection limit should be at least 5×105 U/mL(equivalent to copies/mL),and higher concentrations above the lower detection limit must be positive.A national reference panel for the SARS-CoV-2 antigen detection kit has been established.As the standard of SARS-CoV-2 antigen reagents,the reference panel has played a crucial role in the pre-marketing quality evaluation and post-marketing quality supervision in China.

关 键 词：SARS-CoV-2 Antigen detection kit National reference panel Quality standard 

分 类 号：R511[医药卫生—内科学] R446.6[医药卫生—临床医学]