A biomarker is a measured indicator of a variety of processes, and is often used as a clinical tool for the diagnosis of diseases. While the developmental process of biomarkers from lab to clinic is complex, initial exploratory stages often focus on characterizing the potential of biomarkers through utilizing various statistical methods that can be used to assess their discriminatory performance, establish an appropriate cut-off that transforms continuous data to apt binary responses of confirming or excluding a diagnosis, or establish a robust association when tested against confounders. This review aims to provide a gentle introduction to the most common tools found in diagnostic biomarker studies used to assess the performance of biomarkers with an emphasis on logistic regression.

生物标志物是多种过程的测量指标，通常用作诊断疾病的临床工具。虽然生物标志物从实验室到临床的开发过程很复杂，但最初的探索阶段通常侧重于通过利用各种统计方法来表征生物标志物的潜力，这些方法可用于评估其歧视性表现，建立适当的截止点，将连续数据转换为适合确认或排除诊断的二元反应，或在针对混杂因素进行测试时建立强大的关联。本综述旨在简要介绍诊断生物标志物研究中最常用的工具，用于评估生物标志物的性能，重点是逻辑回归。