Ma Tingting, Liu Donglai, Lyu Keliang, Gao Tingting, Shi Dawei, Zhao Lanqing, Shen Shu, Tian Yabin, Xu Sihong, Zhou Haiwei
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.
School of Life Sciences and Medicine, Shandong University of Technology, Zibo 255049, China.
Biosaf Health. 2023 Oct 21;5(6):326-330. doi: 10.1016/j.bsheal.2023.10.002. eCollection 2023 Dec.
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 × 10 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.
建立严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗原检测试剂盒国家参考品并制定质量标准。收集SARS-CoV-2及其他病原体培养物，建立SARS-CoV-2抗原检测国家参考品。对参考品的稳定性和均匀性进行评估。依据世界卫生组织（WHO）指导原则及核酸定量结果，建立质量标准参考品。目前，已成功建立了3批编号为370095-202001、370095-202202和370095-202203的SARS-CoV-2抗原国家参考品。这些国家参考品包括8份阳性样本、20份阴性样本、1份重复性样本和1份最低检测限样本。参考品的稳定性和均匀性符合要求。质量标准如下：阳性和阴性符合率分别为8/8和20/20。中低浓度重复性参考品的10次检测结果应为阳性，显色应均匀（或变异系数不高于20.0%）。最低检测限应至少为5×10 U/mL（相当于拷贝数/mL），最低检测限以上的较高浓度必须为阳性。已建立SARS-CoV-2抗原检测试剂盒国家参考品。作为SARS-CoV-2抗原试剂的标准，该参考品在中国上市前质量评价和上市后质量监管中发挥了关键作用。
