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Article(id=1248601470677963628, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248601466106172220, articleNumber=1001-2494(2024)06-0555-04, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1683129600000, receivedDateStr=2023-05-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1775619388502, onlineDateStr=2026-04-08, pubDate=1711036800000, pubDateStr=2024-03-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1775619388502, onlineIssueDateStr=2026-04-08, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1775619388502, creator=13701087609, updateTime=1775619388502, updator=13701087609, issue=Issue{id=1248601466106172220, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='6', pageStart='469', pageEnd='558', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1775619387412, creator=13701087609, updateTime=1775619937245, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1248603772348420655, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248601466106172220, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1248603772348420656, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1248601466106172220, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=555, endPage=558, ext={EN=ArticleExt(id=1248601470988342139, articleId=1248601470677963628, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines, columnId=1248601467007947584, journalTitle=Chinese Pharmaceutical Journal, columnName=Original article, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To evaluate the capacity of laboratories which participate in the proficiency testing of antigen content inactived COVID-19 vaccines. METHODS Samples of inactived COVID-19 vaccines for proficiency testing were tested for uniformity and stability, and was distributed together with reference and test kits to participating laboratories by cold chain transportation. Three indexes were evaluated: differential test, antigen content detection and laboratory variation. RESULTS The uniformity and stability of the proficiency test samples met the requirements. A total of 14 laboratories participated in this proficiency test and reported the results as required, and the assessment results of three indicators by each laboratory all satisfactory. CONCLUSION China's provincial drug testing institutions and inactivated vaccine manufacturers participating in this proficiency test have good detection capabilities and quality control levels for inactived COVID-19 vaccines.

, correspAuthors=Changgui LI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Kangwei XU, Junzhen GUO, Xiaoming GAO, Xu LU, Yaru QUAN, Xinhua XIANG, Changgui LI), CN=ArticleExt(id=1248601471437132691, articleId=1248601470677963628, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=新型冠状病毒灭活疫苗抗原含量检测能力验证, columnId=1196884516783571586, journalTitle=中国药学杂志, columnName=研究论文, runingTitle=null, highlight=null, articleAbstract=

目的 开展新型冠状病毒灭活疫苗抗原含量检测能力验证,对参加实验室检测能力进行评价。方法 对能力验证用新型冠状病毒灭活疫苗样品进行均匀性和稳定性检验,采用冷链运输方式将新型冠状病毒灭活疫苗样品、参考品及检测试剂盒分发至各参加实验室。考察鉴别试验、抗原含量检测和实验室内变异3项指标。结果 能力验证样品的均匀性和稳定性符合要求,共有14家实验室参加本次能力验证并按要求报告结果,各实验室3项指标考核结果均为满意。结论 参加本次能力验证的我国省级药检机构及灭活疫苗生产企业具有较好的新型冠状病毒灭活疫苗检测能力和质控水平。

, correspAuthors=李长贵, authorNote=null, correspAuthorsNote=
*李长贵,男,研究员 研究方向:病毒性疫苗的质量控制及相关研究 Tel: (010) 53852132
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徐康维,男,博士,副研究员 研究方向:病毒性疫苗的质量控制及相关研究

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徐康维,男,博士,副研究员 研究方向:病毒性疫苗的质量控制及相关研究

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徐康维,男,博士,副研究员 研究方向:病毒性疫苗的质量控制及相关研究

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实验室
代码		 结果(抗原含量与标示量比/%) (样品C/D)
/%
样品A 样品B 样品C 样品D 样品E
301 96 99 99 99 未检出 0.00
216 86 88 92 94 未检出 1.52
369 96 99 95 96 未检出 0.74
754 97 105 106 104 未检出 1.35
759 104 107 112 110 未检出 1.27
138 102 101 101 103 未检出 1.39
561 102 108 107 106 未检出 0.66
629 100 102 100 100 未检出 0.00
258 82 95 94 101 未检出 5.08
112 108 112 107 104 未检出 2.01
084 96 104 103 105 未检出 1.36
484 99 100 100 104 未检出 2.77
502 92 102 98 103 未检出 3.52
587 94 99 94 101 未检出 5.08
), ArticleFig(id=1248653096558154431, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248601470677963628, language=CN, label=表1, caption=

各参加实验室新型冠状病毒灭活疫苗抗原含量报告结果

, figureFileSmall=null, figureFileBig=null, tableContent=
实验室
代码		 结果(抗原含量与标示量比/%) (样品C/D)
/%
样品A 样品B 样品C 样品D 样品E
301 96 99 99 99 未检出 0.00
216 86 88 92 94 未检出 1.52
369 96 99 95 96 未检出 0.74
754 97 105 106 104 未检出 1.35
759 104 107 112 110 未检出 1.27
138 102 101 101 103 未检出 1.39
561 102 108 107 106 未检出 0.66
629 100 102 100 100 未检出 0.00
258 82 95 94 101 未检出 5.08
112 108 112 107 104 未检出 2.01
084 96 104 103 105 未检出 1.36
484 99 100 100 104 未检出 2.77
502 92 102 98 103 未检出 3.52
587 94 99 94 101 未检出 5.08
), ArticleFig(id=1248653096642040515, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248601470677963628, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
样品 样本量 均值 中位值(指定值) 差值D限度 标准差 CV/% 最小值 最大值
A 14 97 97 19 6.88 7.11 82 108
B 14 102 102 20 5.87 5.78 88 112
C/D 28 101 101 20 5.03 4.97 92 112
), ArticleFig(id=1248653096751092424, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1248601470677963628, language=CN, label=表2, caption=

各参加实验室新型冠状病毒灭活疫苗抗原含量检测结果汇总计量

, figureFileSmall=null, figureFileBig=null, tableContent=
样品 样本量 均值 中位值(指定值) 差值D限度 标准差 CV/% 最小值 最大值
A 14 97 97 19 6.88 7.11 82 108
B 14 102 102 20 5.87 5.78 88 112
C/D 28 101 101 20 5.03 4.97 92 112
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新型冠状病毒灭活疫苗抗原含量检测能力验证
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徐康维 1 , 郭君贞 2 , 高晓明 1 , 鲁旭 1 , 权娅茹 1 , 项新华 1 , 李长贵 1, *
中国药学杂志 | 研究论文 2024,59(6): 555-558
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中国药学杂志 | 研究论文 2024, 59(6): 555-558
新型冠状病毒灭活疫苗抗原含量检测能力验证
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徐康维1, 郭君贞2, 高晓明1, 鲁旭1, 权娅茹1, 项新华1, 李长贵1, *
作者信息
  • 1 中国食品药品检定研究院, 北京 102629
  • 2 山东省食品药品检验研究院, 济南 250101

    • 徐康维,男,博士,副研究员 研究方向:病毒性疫苗的质量控制及相关研究

通讯作者:

*李长贵,男,研究员 研究方向:病毒性疫苗的质量控制及相关研究 Tel: (010) 53852132
Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines
Kangwei XU1, Junzhen GUO2, Xiaoming GAO1, Xu LU1, Yaru QUAN1, Xinhua XIANG1, Changgui LI1, *
Affiliations
  • 1 National Institutes for Food and Drug Control, Beijing 102629, China
  • 2 Shandong Institute for Food and Drug Control, Jinan 250101, China
出版时间: 2024-03-22
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摘要
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目的 开展新型冠状病毒灭活疫苗抗原含量检测能力验证,对参加实验室检测能力进行评价。方法 对能力验证用新型冠状病毒灭活疫苗样品进行均匀性和稳定性检验,采用冷链运输方式将新型冠状病毒灭活疫苗样品、参考品及检测试剂盒分发至各参加实验室。考察鉴别试验、抗原含量检测和实验室内变异3项指标。结果 能力验证样品的均匀性和稳定性符合要求,共有14家实验室参加本次能力验证并按要求报告结果,各实验室3项指标考核结果均为满意。结论 参加本次能力验证的我国省级药检机构及灭活疫苗生产企业具有较好的新型冠状病毒灭活疫苗检测能力和质控水平。

新型冠状病毒灭活疫苗  /  酶联免疫吸附试验  /  能力验证

OBJECTIVE To evaluate the capacity of laboratories which participate in the proficiency testing of antigen content inactived COVID-19 vaccines. METHODS Samples of inactived COVID-19 vaccines for proficiency testing were tested for uniformity and stability, and was distributed together with reference and test kits to participating laboratories by cold chain transportation. Three indexes were evaluated: differential test, antigen content detection and laboratory variation. RESULTS The uniformity and stability of the proficiency test samples met the requirements. A total of 14 laboratories participated in this proficiency test and reported the results as required, and the assessment results of three indicators by each laboratory all satisfactory. CONCLUSION China's provincial drug testing institutions and inactivated vaccine manufacturers participating in this proficiency test have good detection capabilities and quality control levels for inactived COVID-19 vaccines.

inactived COVID-19 vaccine  /  ELISA  /  proficiency testing
徐康维, 郭君贞, 高晓明, 鲁旭, 权娅茹, 项新华, 李长贵. 新型冠状病毒灭活疫苗抗原含量检测能力验证. 中国药学杂志, 2024 , 59 (6) : 555 -558 .
Kangwei XU, Junzhen GUO, Xiaoming GAO, Xu LU, Yaru QUAN, Xinhua XIANG, Changgui LI. Laboratory Proficiency Testing for Antigen Content of Inactived COVID-19 Vaccines[J]. Chinese Pharmaceutical Journal, 2024 , 59 (6) : 555 -558 .
正文
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接种疫苗是传染病防控最为经济有效的手段,我国具备全部疫苗品种的完善供应体系,目前有46家疫苗生产企业,能够生产超过60种疫苗用以预防34种疾病,年产能超过10亿剂[1-2]。我国实行生物制品批签发制度对获得上市许可的疫苗通过资料审核、样品检验等方式进行监管,中国食品药品检定研究院(以下简称中检院)承担了疫苗的批签发检验工作。由于疫苗行业的快速发展,为缩短批签发时间,保证疫苗的供应,我国加快省级药检机构的建设,以增加批签发授权机构,建立以中检院作为核心,省级批签发机构作为支持的批签发网络实验室[3]。在新型冠状病毒疫情的应对中,新型冠状病毒灭活疫苗在我国接种人数最多,且通过了世界卫生组织(WHO)的认证并列入紧急使用清单,在全球多个国家和地区广泛应用。2021年中检院对我国多家省级药检机构进行了新型冠状病毒疫苗检验相关培训,并进行了能力考核。北京市药品检验研究院、上海市食品药品检验研究院、湖北药品监督检验研究院等多家省级药检机构通过了国家药品监督管理局考核并获得批签发授权[2]。为了增加各批签发授权机构的技术交流,提高检测质量水平,中检院开展新型冠状病毒灭活疫苗抗原含量检测能力验证计划(NIFDC-PT-396)。本能力验证计划是国家药品监督管理局负责的项目,依据能力验证体系文件的要求及人用药品技术要求国际协调理事会(The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,ICH)《M10:生物分析方法验证及样品分析》指导原则进行运作实施[4-8]。
1 材料与方法
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1.1 能力验证样品与试剂
能力验证使用的样品、参考品及检验试剂盒(北京科兴中维生物技术有限公司惠赠)。样品一套5支,包含以下样品各1支:编号末尾为A的为高剂量样品;编号末尾为B、C、D的为中剂量样品,其中C、D同为X批次样品,考察实验室内变异;编号末尾为E的为阴性样品(铝佐剂)。各参加实验室分发样品5套,参考品5支和检验试剂盒5个,由中检院委托上海生生物流有限公司冷链运输至各参加实验室。
1.2 检验方法
采用分发的新冠疫苗抗原含量参考品及检测试剂盒,并按照试剂盒说明书采用酶联免疫吸附试验(ELISA)方法对样品进行检测,报告抗原含量与标示量比值。每实验室报告3次样品检测结果和平均结果。参加实验室在收到样品后10个工作日内完成实验,并在能力验证网络平台上提交结果报告。
1.3 均匀性检验
分别从A、B、C、E 4批次样品中随机取样10支,每支样品进行2次抗原含量检测,对同一批次样品的测定结果进行单因子方差分析(F检验),显著性水平取0.05。如样品之间无显著性差异,则表明样品均匀。
1.4 稳定性检验
将A、B、C/D 3批次阳性样品委托上海生生物流有限公司,从北京以2~8 ℃冷链运输至济南或沈阳后,返回中检院,将实验室正常保存样品和冷链运输返回后样品均按照新型冠状病毒灭活疫苗抗原含量检测方法进行测定,正常保存的样品和运输至济南或沈阳后返回的样品各检测3支,每支样品测定2次。对结果进行t检验,显著性水平取0.05。如正常保存和运输后样品之间抗原含量无显著性差异,则表明样品稳定。
1.5 统计分析方法及评价原则
按照《能力验证的选择核查与利用指南》(CNAS-GL40),《能力验证结果的统计处理和能力评价指南》(CNAS-GL02)和ICH《M10:生物分析方法验证及样品分析》指导原则等文件的要求对参加实验室结果进行评价,评价项目包括以下3项:
1.5.1 鉴别试验
A、B、C/D样品为阳性样品,应可检出新型冠状病毒抗原,E样品为阴性样品,应未检出新型冠状病毒抗原。满足上述条件,结果为“满意”,任一样品不满足上述条件,结果为“不满意”。
1.5.2 抗原含量检测
A、B、C/D样品选用参加者确定的中位值作为指定值(X),参照ICH 《M10:生物分析方法验证与样品分析》指导原则中关于配体结合分析试验要求,以指定值的20%(20%X)作为差值D的限度(D=x-X,其中x为参加者结果; X为指定值)。|D|≤20%X结果为“满意”,|D|>20%X结果为“不满意”。所有样品结果均为“满意”判定为“满意”。
1.5.3 实验室内变异
C、D两样品为同一批次样品,计算同一参加单位两样品检测结果的变异系数CV(%)。CV(%)≤15结果为“满意”,15<CV(%)≤20结果为“可疑”,CV(%)>20结果“不满意”。
1.6 统计学分析软件
使用SPSS 20和Excel 2016软件对结果进行统计分析。
2 结果
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2.1 均匀性检验结果
每批次样品随机抽取10支,每支进行两次抗原含量检测。采用单因子方差分析(F检验)对样品抗原含量的20个结果进行均匀性评价,A批次F(2.80)<F临界值(3.02),B批次F(1.90)<F临界值(3.02),C/D批次F(0.10)<F临界值(3.02),三个批次P值均大于0.05,无显著性差异。而E批次样品结果均为“未检出”。上述结果表明样品均匀性满足能力验证的要求。
2.2 稳定性检验结果
对正常保存样品和冷链运输后样品抗原含量进行比较。对于A样品,以2~8 ℃冷链运输至济南或沈阳后返回中检院样品抗原含量平均为正常保存样品的95.60%和102.87%,P值分别为0.270和0.362。对于B样品,以2~8 ℃冷链运输至济南或沈阳后返回中检院样品抗原含量平均为正常保存样品的100.40%和97.62%,P值分别为0.854和0.194。对于C/D样品,以2~8 ℃冷链运输至济南或沈阳后返回中检院样品抗原含量平均为正常保存样品的103.72%和102.81%,P值分别为0.353和0.521。样品在运输前后抗原含量均无显著性差异,表明样品稳定性可以满足能力验证的要求。
2.3 能力验证结果
本次能力验证共有14家实验室参加,包括12家省级药检机构和2家新冠灭活疫苗生产企业。全部参加验证的实验室均进行了结果反馈。
2.3.1 鉴别试验结果
如表1所示,所有实验室A、B、C/D样品均检测出新型冠状病毒抗原, E样品均未检出新型冠状病毒抗原。评价结果均为满意。
2.3.2 抗原含量结果
对各实验室报告结果进行汇总分析,样品A、B单独分析,样品C/D实际为同一批样品,检测结果进行合并分析,汇总计量结果见表2。样品A检测结果频数分布见图1A,呈单峰,近正态分布。各实验室检测结果均值与中位值均为97,以中位值97作为指定值,差值D限度为19。样品B检测结果频数分布见图1B,呈单峰,近正态分布。各实验室检测结果均值与中位值均为102,以中位值102作为指定值,差值D限度为20。样品C/D检测结果频数分布见图1C/D,呈单峰,近正态分布。各实验室检测结果均值与中位值均为101,以中位值101作为指定值,差值D限度为20。各实验室评价结果均为满意。
2.3.3 实验室内变异
结果见表1,各实验室检测C/D两样品平均结果间CV最大为5.08%,最小为0,均小于15%,评价结果均为满意。
3 讨论
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ELISA是经典的免疫学检测方法,检测灵敏度高,特异性好,具有较高的检测通量且无需复杂昂贵的仪器设备,在疫苗的抗原含量检测中广泛应用[9-11]。我国多家企业生产的新冠灭活疫苗,也采用ELISA方法进行抗原含量的检测[12-13]。本次能力验证对参加实验室的ELISA方法检测能力进行了考核。由于疫苗产品多样且检测方法具有很高的特异性,各种检测方法间的可比性难以评价。为此本次能力验证统一采用的北京科兴中维生物技术有限公司建立的抗原含量检测ELISA方法。中检院为各参加实验室提供了参考品、检验试剂盒及作业指导书(方法操作指南),来保证检测方法的一致性。
各个实验室均发放A、B、C/D、E 5个批次样品,用以考察鉴别试验、抗原含量和实验室内变异3项指标,参加本次能力验证的12家省级药检机构和2家新冠灭活疫苗生产企业实验室3项考核均为满意,表明我国批签发网络实验室质量体系的建设工作卓有成效。
同时,此次能力验证也是对该抗原含量检测方法的一次实验室间验证。向每个参加实验室发放的C、D两编号样品实际为同一批号样品,考察实验室内精密度,各实验室CV最大为5.08%,最小为0。3批样品各实验室间检测结果CV分别为7.11%、5.78%、4.97%。实验室内和实验室间变异均小于ICH M10的上限20%,表明本方法具有良好的精密度。
基金
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  • 国家科技重大专项资助(2018ZX09738-005)
  • 国家科技重大专项资助(2018ZX09737-003)
  • 北京市自然科学基金项目资助(L192009)
文献
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参考文献 引证文献
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2024年第59卷第6期
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  • 接收时间：2023-05-04
  • 首发时间：2026-04-08
  • 出版时间：2024-03-22
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  • 收稿日期：2023-05-04
基金
国家科技重大专项资助(2018ZX09738-005)
国家科技重大专项资助(2018ZX09737-003)
北京市自然科学基金项目资助(L192009)
作者信息
    1 中国食品药品检定研究院, 北京 102629
    2 山东省食品药品检验研究院, 济南 250101

通讯作者:

*李长贵,男,研究员 研究方向:病毒性疫苗的质量控制及相关研究 Tel: (010) 53852132
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2种不同金属材料的力学参数
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Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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