山西医科大学学报2026，Vol.57Issue(5)：613-616,4.DOI:10.13753/j.issn.1007-6611.2026.05.014
细胞成像分析技术在病毒蚀斑定量检测中的应用与评价
Application and evaluation of cell imaging analysis technology in quantitative detection of viral plaques
摘要
Abstract
Objective To explore the accuracy,precision,and reliability of cell imaging technology in the quantitative detection of viral plaque.Methods According to the ICH guidelines and Chinese Pharmacopoeia requirements,the accuracy and precision of the plaque assay based on cell imaging technology,and the correlation between results by cell imaging technology and manual visual counting were validated.Results Based on the results determined by cell imaging technology,the relative bias of accuracy at high,medium,and low concentration levels of samples were 0,12%,and-2%,respectively,with a linear regression equation of y=1.001 8x+0.006 8.The geometric coefficient of variation(GCV)for intra-day repeatability was 11%-15%,and the GCV for inter-day intermediate precision was 20%.The results determined by cell imaging technology and manual visual counting were highly correlated(r=0.998 7,P<0.000 1),and the results showed no statistically significant difference between the two methods(t=1.387,P=0.175).Conclusion The plaque assay result based on cell imaging technology demonstrates good accuracy,precision,and high correlation with manual counting,and is suitable for quality evaluation of viral products.关键词
细胞成像技术/病毒滴度/蚀斑法/方法验证/质量控制Key words
cellular imaging technology/virus titer/plaque assay/method validation/control quality分类
医药卫生引用本文复制引用
刘悦越,赵荣荣,刘丽,彭竞卉,权娅茹..细胞成像分析技术在病毒蚀斑定量检测中的应用与评价[J].山西医科大学学报,2026,57(5):613-616,4.基金项目
药品监管科学全国重点实验室课题(2025SKLDRS0357) （2025SKLDRS0357）
