细胞成像分析技术在病毒蚀斑定量检测中的应用与评价OA

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.