目的验证重组乙型肝炎（乙肝）疫苗（酿酒酵母）中宿主细胞蛋白残留量ELISA定量检测方法。
方法使用 S. cerevisiae HCP ELISA Kit检测试剂盒，对重组乙肝疫苗（酿酒酵母）中的宿主细胞蛋白残留量进行检测，并验证该方法的线性、准确度、重复性、定量限、专属性及中间精密度。
结果ELISA检测标准品的曲线线性良好（决定系数≥0.97），最低点吸光度（ A 405/492）值＜0.300，最高点 A 405/492值＞1.000；同一检测人员对低、中、高3个浓度的加标样品进行3次重复检测，检测回收率在80%~120%；对中浓度样品重复检测6次，样品回收率在80%~120%，相对标准偏差＜10%，表明方法具有良好的准确度和重复性。样品背景溶液和样品稀释液的 A 405/492值均小于曲线最低点，表明该方法的专属性强；定量限为2 ng/mL；不同实验组在不同时间对中浓度样品重复检测6次，相对标准偏差＜10%，中间精密度良好。
结论ELISA检测重组乙肝疫苗（酿酒酵母）宿主细胞蛋白残留量具有良好的线性、准确度、重复性、定量限、专属性及中间精密度，可用于乙肝疫苗生产的过程控制。
ObjectiveTo validate a quantitative ELISA method for the detection of residual host cell protein (HCP) in recombinant hepatitis B vaccine ( Saccharomyces cerevisiae).
MethodsThe S. cerevisiae HCP ELISA Kit was used to detect HCP residues in recombinant hepatitis B vaccine ( Saccharomyces cerevisiae), and the linearity, accuracy, repeatability, limit of quantification, specificity and intermediate precision of the method were verified.
ResultsThe ELISA standard curve had good linearity (coefficient of determination ≥ 0.97), with the lowest absorbance ( A 405/492) value <0.300, and the highest A 405/492 value >1.000. With same experimenter, samples added with low, medium and high concentration standards were detected 3 times, and the recovery rates were 80%-120%. Medium concentration standard-added sample was detected 6 times, and the relative standard deviation (RSD) was <10%, indicating good accuracy and repeatability of the method. The A 405/492 values of the sample background solution and the sample diluent were both smaller than the lowest point of the curve, indicating that the method was highly specific. The medium concentration standard-added sample was detected by different experimenter groups at different time for 6 times, and the RSD was <10%, indicating good intermediate precision of the method.
ConclusionThe ELISA method for the detection of HCP residues in recombinant hepatitis B vaccine ( Saccharomyces cerevisiae) has good linearity, accuracy, repeatability, limit of quantification, specificity and intermediate precision, thus can be used for the process control of hepatitis B vaccine production.
刘玉美,齐亭娟,张晓蕙,等. 重组乙型肝炎疫苗（酿酒酵母）中宿主细胞蛋白残留量检测方法的验证[J]. 国际生物制品学杂志,2025,48(01)：46-49.
DOI:10.3760/cma.j.cn311962-20240918-00062版权归中华医学会所有。
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刘玉美：实验设计、研究实施、数据分析；齐亭娟：数据采集、支持性贡献；张晓蕙、陈若兰、陈国明、柳易程：数据采集、统计分析；丁玲、栗妍：统计分析、论文修改、研究指导；黄祎：实验设计、数据采集、数据分析、论文撰写
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