Abstract：OBJECTIVE To acquire the knowledge of quality control performance through carrying out proficiency Testing Schemes (PTS) nationwide. METHODS National Institutes for Food and Drug Control(NIFDC) schemed three PTS to evaluate the testing competence of participants from the aspects of safety and stability of vaccine products and pseudotyped virus-based neutralization assay, pseudotyped virus based neutralization assay(PBNA), which takes as a hand of COVID-19 vaccine development. RESULTS Eighty-nine participants took part in the three PTS and the satisfaction rate stated as 96.9%, 96.4% and 76.0%. CONCLUSION The testing ability and quality control performance of Official Medical Control Laboratories (OMCL), manufacturers and research institutes are acceptable. The testing results of sterile testing and aluminum assay of aluminum adjuvanted vaccine can be assured well, while the ability of PBNA needs to be improved by some manufacturers.
刘雅丹, 项新华, 黄维金, 王斌, 胡忠玉, 于欣. 2020年国家级疫苗检测能力验证的结果与分析[J]. 中国药学杂志, 2021, 56(13): 1099-1103.
LIU Ya-dan, XIANG Xin-hua, HUANG Wei-jin, WANG Bin, HU Zhong-yu, YU Xin. Results and Discussion on National Vaccine Proficiency Testing Schemes in 2020. Chinese Pharmaceutical Journal, 2021, 56(13): 1099-1103.
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