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目的制备用于检测重组酵母表达的adr亚型HBsAg含量的实验参考品。方法重组酵母表达的adr亚型HBsAg溶液经纯化后,经3家实验室联合标定蛋白含量,准确稀释并加入保护剂,使抗原最终含量为10μg/ml,分装安瓿后,冷冻干燥熔封,制备成adr亚型实验参考品。再由不同实验室用不同试剂和不同方法,以联合标定的蛋白含量为定量标准,分别验证冻干参考品中adr亚型HBsAg含量及37℃放置不同时间的稳定性。并以adw亚型HBsAg标准作为定量标准,检测adr亚型参考品中HBsAg含量。结果所制备的adr亚型冻干参考品分装准确均匀;以联合标定蛋白含量为标准,不同实验室分别以珠式EIA法和RIA法所测的adr亚型冻干参考品HBsAg含量与目标含量相近,各支参考品间差异小;adr亚型冻干实验参考品37℃放置2～10周后质量稳定。以adw亚型HBsAg参考品为定量标准,所测定adr亚型冻干参考品HBsAg含量,比实际含量约高出0.6倍。结论冻干adr亚型HBsAg实验参考品可用于重组酵母表达adr亚型HBsAg的定量检测。不同亚型HBsAg检测需用各自亚型的参考品作为定量标准。
Objective To prepare an experimental reference for detecting the HBsAg content of adr subtype in recombinant yeast. Methods Recombinant yeast-derived adr subtype HBsAg solution was purified by three laboratories combined calibration protein content, accurate dilution and added protective agent, so that the final antigen content of 10μg / ml, ampoule ampoules, freeze-dried and sealed, Prepared adr subtype experimental reference materials. Then different laboratories with different reagents and different methods to jointly calibrate the protein content as a quantitative standard, respectively, to verify the freeze-dried reference substance adr subtype HBsAg content and 37 ℃ placed at different times of stability. Adverse rates of HBsAg in adr subtype were also determined using adw subtype of HBsAg as a quantitative standard. Results The prepared adr subtype freeze-dried reference material was accurately and evenly distributed. The content of HBsAg in adr subtype freeze-dried reference substance and the target Similar content of each reference small difference between; adr subtype freeze-dried experimental reference material placed at 37 ℃ 2 to 10 weeks after the quality is stable. To adw subtype of HBsAg reference standard for quantitative determination of adr subtype freeze-dried reference HBsAg content, about 0.6 times higher than the actual content. Conclusions The reference sample of lyophilized adr subtype of HBsAg can be used for the quantitative detection of HBsAg in adr subtype of recombinant yeast. Different subtypes of HBsAg testing need to use their own sub-type of reference as a quantitative standard.