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Statistical Method for Determining and Comparing Limits of Detection of Bioassays

检出限 度量(数据仓库) 生物测定 分析物 极限(数学) 统计 灵敏度(控制系统) 生物系统 化学 计算机科学 数据挖掘 数学 色谱法 遗传学 生物 工程类 数学分析 电子工程
作者
Carly A. Holstein,Maryclare Griffin,Hong Jing,Paul D. Sampson
出处
期刊:Analytical Chemistry [American Chemical Society]
卷期号:87 (19): 9795-9801 被引量:108
标识
DOI:10.1021/acs.analchem.5b02082
摘要

The current bioassay development literature lacks the use of statistically robust methods for calculating the limit of detection of a given assay. Instead, researchers often employ simple methods that provide a rough estimate of the limit of detection, often without a measure of the confidence in the estimate. This scarcity of robust methods is likely due to a realistic preference for simple and accessible methods and to a lack of such methods that have reduced the concepts of limit of detection theory to practice for the specific application of bioassays. Here, we have developed a method for determining limits of detection for bioassays that is statistically robust and reduced to practice in a clear and accessible manner geared at researchers, not statisticians. This method utilizes a four-parameter logistic curve fit to translate signal intensity to analyte concentration, which is a curve that is commonly employed in quantitative bioassays. This method generates a 95% confidence interval of the limit of detection estimate to provide a measure of uncertainty and a means by which to compare the analytical sensitivities of different assays statistically. We have demonstrated this method using real data from the development of a paper-based influenza assay in our laboratory to illustrate the steps and features of the method. Using this method, assay developers can calculate statistically valid limits of detection and compare these values for different assays to determine when a change to the assay design results in a statistically significant improvement in analytical sensitivity.
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