计算机科学
变异系数
色谱法
方差分析
计算生物学
化学
数据挖掘
统计
数学
生物
作者
Zhihua Jiang,John Kamerud,Zhiping You,Soma Basak,Elena Seletskaia,Gregory S. Steeno,Boris Gorovits
出处
期刊:Bioanalysis
[Newlands Press Ltd]
日期:2021-07-01
卷期号:13 (14): 1123-1134
被引量:3
标识
DOI:10.4155/bio-2021-0095
摘要
Aim: To investigate the feasibility of singlicate analysis in anti-drug antibody (ADA) assay by comparing performance characteristics for assays qualified in duplicate and singlicate formats. Materials & methods: We employed modeling to assess and quantify the impact of singlicate to cut point factor (CPF) in scenarios with the duplicate precision from 1-20% and the proportion of well-to-well variance to overall assay variance from 0.01-0.90. The impact to CPF by singlicate is marginal if the well-to-well coefficient of variation is <10% and represents <25% of the overall variability. Results & conclusion: The assay parameters including sensitivity, precision, selectivity, drug and target tolerance were comparable between singlicate and duplicate based assays. Our results suggested the minimal impact of singlicate analysis on ADA assay with good duplicate precision. The study provided additional supportive evidence that the singlicate-based analysis is feasible in ADA ligand binding assays.
科研通智能强力驱动
Strongly Powered by AbleSci AI