| 刘正玲,李娅娴,赵勇,杜宋婷,王汉慧,蒋曦,贺凌煜,袁明翠,常亚军.以EV71抗原检测方法验证浅析生物制品生物效价检测方法学验证[J].中国药品标准,2023,24(2): |
| 以EV71抗原检测方法验证浅析生物制品生物效价检测方法学验证 |
| A brief analysis for biovalence detection method of biological products by EV71 antigen detection method |
| 投稿时间：2022-07-11 修订日期：2023-03-31 |
| DOI： |
| 中文关键词: 中国药典2020年版 生物制品 生物活性/效价 方法学验证 EV71抗原检测 |
| 英文关键词: Chinese pharmacopoeia 2020 biological products biological activity/potency methodological validation EV71 antigen detection |
| 基金项目: |
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| 中文摘要: |
| 摘要 目的：本文以对生物制品生物效价检测进行规范的《中国药典》2020年版新增9401指导原则为标准进行EV71抗原检测方法的验证，进一步浅析生物制品生物活性/效价检测的方法学验证。方法： 依据《中国药典》2020年版9401指导原则，结合EV71抗原检测方法特点及验证目的对其进行专属性、相对准确度、精密度、线性和范围5个方面进行方法学验证。结果： EV71抗原检测方法专属性强，6个效价水平几何变异系数为4.7%~13.0%，均小于15%，相对偏倚为-6.05%~9.03%，均在±15%范围内，定量范围为225%~31%，线性回归相关系数为0.9995，5方面验证均符合要求，且适用于该检测方法的使用。结论：本原则可具体指导生物学检测方法验证，在对不同检测方法进行验证时，根据检测目的、方法的原理、方法的技术特点、被检物的成分等设计具体方案。 |
| 英文摘要: |
| Abstract Objective： In this paper, the EV71 antigen detection method verified according to the new 9401 guidelines in the 2020 edition of the Chinese Pharmacopoeia which is used for standardizing the biological activity testing of biological products, and further analyzes the methodological verification of the biological activity / titer detection of biological products. Methods： According to the guideline of Chinese Pharmacopoeia 2020 edition 9401, and combined with the characteristics and verification purpose of EV71 antigen detection method, the methodology verification was conducted in five aspects: exclusivity, relative accuracy, precision, linearity and scope. Results： EV71 antigen detection method has strong specificity, the geometric variation coefficient of the six potency levels is 4.7%-13.0%, all of which are less than 15%, the relative bias is -6.05%-9.03%, all within the range of ± 15%, the quantitative range is 225%-31%, and the linear regression correlation coefficient is 0.9995, and the 5 aspects of verification are all in line with the requirements and are suitable for the use of this detection method. Conclusion： This guideline can specifically guide the verification of biological testing methods. In the verification of different testing methods, specific schemes can be designed according to the testing purpose of the method, the principle of the method, the technical characteristics of the method, and the composition of the tested object. |
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