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作 者:张影[1] 鲁旭[1] 王斌[1] 曾明[1] ZHANG Ying;LU Xu;WANG Bin;ZENG Ming(National Institutes for Food and Drug Control,Key Laboratory of Research on Quality and Standardization of Bio-tech Products,Beijing 102629,China)
机构地区:[1]中国食品药品检定研究院生物技术产品检定方法及其标准化重点实验室
出 处:《中华临床免疫和变态反应杂志》2019年第5期355-360,共6页Chinese Journal of Allergy & Clinical Immunology
基 金:中国医学科学院中央级公益性科研院所基本科研业务费项目(2018PT34046)~~
摘 要:目的探索建立Der. f 1含量测定抗原、抗体国家标准品的可行性。方法首先对粉尘螨1组主要变应原(Der. f 1)含量测定用的3种不同企业抗原标准品(ST-H011、MS-14、EL-UAS)进行比较分析,筛选适用性好的抗原标准品;进一步对3种抗体系统(5-17/Der1-BD、14-1/12G2、6A8/4C1)进行比较,筛选最佳检测抗体系统;最后再进一步利用两种抗原标准品和3种抗体系统对不同企业粉尘螨变应原制品中的Der. f 1进行含量测定。结果 ST-H011和MS-14用于测定Der. f 1含量具有较好的通用性,EL-UAS用于Der. f 1含量测定结果与前两者差异较大;3种Der. f 1特异性抗体检测系统具有较好的通用性;利用上述两种Der. f 1抗原标准品和3种抗体系统测定各企业粉尘螨变应原制品中的Der. f 1含量时,结果均符合质量标准规定。结论两种Der. f 1抗原标准品及三种抗体系统测定粉尘螨变应原中Der. f 1含量,均具有较好的通用性和适用性,其中14-1/12G2抗体测定结果的一致性最好,可作为Der. f 1含量测定用抗体国家标准品的候选。Objective To explore the feasibility of establishing national standard of antigen and antibodies for determination of Der.f 1 content.Methods Firstly,three kinds of in-house antigen references for determination of Der.f 1(ST-H011,MS-14,and EL-UAS)were compared and analyzed.Furthermore,three antibody systems were used to determine Der.f 1 in ST-H011 and MS-14.Finally,the content of Der.f 1 in D.farinae allergen products of different enterprises was determined by using two kinds of in-house antigen standards and three antibody systems,the results were compared.Results ST-H011 and MS-14 were shown good generality for determination of Der.f 1 content,while the results of Der.f 1 content determined by EL-UAS were significantly different from the other two antigen standards.By using the 14-1/12 G2 antibody systems,the contents of Der.f 1 in ST-H011 and MS-14 antigens were both close to the indicated content.The Der.f 1 contents in D.farinae allergen from three enterprise were consistency by using 14-1/12 G2 antibody with MS-14 and ST-H011 antigens.Conclusions The determination of Der.f 1 content in D.farinae allergen by using two antigen standards and three antibody systems showed good commonality and applicability.The 14-1/12 G2 is the best antibody system and can be a candidate for national standard of antibodies for Der.f 1 content determination.
关 键 词:粉尘螨 粉尘螨1组主要变应原 ELISA夹心法 抗原标准品 抗体标准品
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