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作 者:江征[1] 朱文慧 宋彦丽[1] 刘婷[1] 张雪子 英志芳[1] 王剑锋[1] 李长贵[1] JIANG Zheng;ZHUWen-hui;SONG Yan-li;LIU Ting;ZHANG Xue-zi;YING Zhi-fang;WANG Jian-feng;LI Chang-gui(National Institutes for Food and Drag Control,Beijing 102629,China)
出 处:《中国生物制品学杂志》2021年第6期712-716,共5页Chinese Journal of Biologicals
基 金:国家科技重大专项(2018ZX09737-003)。
摘 要:目的对第1代Sabin株脊髓灰质炎灭活疫苗(inactivated poliomyelitis vaccine prepared with Sabin strain,sIPV)D抗原含量国际标准品进行国际协作标定。方法13家协作单位分别采用NIBSC提供的统一检测方法及各单位自建方法,对以野毒株生产的脊髓灰质炎灭活疫苗(conventional inactivated poliolyelitis vaccine,cIPV)D抗原含量国际标准品12/104及其替代参考物质08/143、来自不同制造商的两种sIPV候选标准品17/130、17/160及其他3个sIPV样品进行D抗原含量检测,并分析试验有效性和实验室内、实验室间结果的一致性。结果无论采用何种方法,以sIPV候选标准品为参考标准时,有效试验的比例均较以12/104为参考标准时更高,且实验室内的变异度总体较低,D抗原含量几何平均值(geometric mean,GM)在实验室间有较好的一致性。结论两种sIPV候选标准品均适合作为国际标准,但17/160在试验有效性及实验室内、实验室间的一致性略好,选定为第1代sIPV D抗原含量检测的国际标准品。Objective To collabratively calibrate the first international standard(IS)for D antigen(D-Ag)content of inactivated polio vaccine prepared with Sabin strain(sIPV).Methods Thirteen participants were requested to determine the D-Ag contents of two sIPV candidate IS samples 17/130 and 17/160 from different manufacturers along side with other three sIPV study samples,as well as the current 3rd IS 12/104 for conventional IPV(cIPV)and the cIPV International Reference 08/143 by the routine in-house immunochemical methods and a common method(NIBSC reagents).The assay validity as well as the inter-laboratory and intra-laboratory variability were statistically evaluated and compared.Results Whichever of the two candidate sIPV standards was used to determine the D antigen content of sIPV products,the proportion of valid assays was higher than that when 12/104 was used,while the intra-laboratory variation was generally lower,and the geometric mean of D-Ag content was well consistent between laboratories.Conclusion Both sIPV candidates are suitable to serve as IS.Candidate 17/160 is chosen as the 1st IS because of overall results of assay validity as well as the interlaboratory and intra-laboratory variability.
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