{"title":"2020年国家疫苗水平检测方案实施结果与探讨","authors":"Y. Liu, X. Xiang, W. Huang, B. Wang, Z. Hu, X. Yu","doi":"10.11669/cpj.2021.13.013","DOIUrl":null,"url":null,"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.","PeriodicalId":22409,"journal":{"name":"The Chinese Pharmaceutical Journal","volume":"43 1","pages":"1099-1103"},"PeriodicalIF":0.0000,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Results and Discussion on National Vaccine Proficiency Testing Schemes in 2020\",\"authors\":\"Y. Liu, X. Xiang, W. Huang, B. Wang, Z. Hu, X. Yu\",\"doi\":\"10.11669/cpj.2021.13.013\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":22409,\"journal\":{\"name\":\"The Chinese Pharmaceutical Journal\",\"volume\":\"43 1\",\"pages\":\"1099-1103\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Chinese Pharmaceutical Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.11669/cpj.2021.13.013\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Chinese Pharmaceutical Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.11669/cpj.2021.13.013","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Results and Discussion on National Vaccine Proficiency Testing Schemes in 2020
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.
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