Kolev Mirjam, Horn Michael P, Semmo Nasser, Nagler Michael
Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital Bern, University of Bern, Bern, Switzerland.
Departement of Clinical Chemistry, Inselspital Bern, University of Bern, Bern, Switzerland.
J Transl Autoimmun. 2022 Mar 6;5:100151. doi: 10.1016/j.jtauto.2022.100151. eCollection 2022.
Clear guidance is needed in the development and implementation of laboratory biomarkers in medicine. So far, no standardized phased approach is established that would pilot researchers and clinicians in this process. This leads to often incompletely validated biomarkers, which can bear the consequence of wrong applications, misinterpretation and inadequate management in the clinical context. In this conceptual article, we describe a stepwise approach to develop and comprehensively validate laboratory biomarkers. We will delineate basic steps including technical performance, pre-analytical issues, and biological variation, as well as advanced aspects of biomarker utility comprising interpretability, diagnostic and prognostic accuracy, and health-care outcomes. These aspects will be illustrated by using well-known examples from the field of immunology. The application of this conceptual framework will guide researchers in conducting meaningful projects to develop and evaluate biomarkers for the use in clinical practice. Furthermore, clinicians will be able to adequately interpret pre-clinical and clinical diagnostic literature and rationally apply biomarkers in clinical practice. Improvement in the implementation and application of biomarkers might relevantly change the management and outcomes of our patients for the better.
医学领域实验室生物标志物的开发与应用需要明确的指导。到目前为止，尚未建立标准化的分阶段方法来指导研究人员和临床医生开展这一过程。这常常导致生物标志物验证不充分，可能会在临床环境中产生错误应用、错误解读和管理不当的后果。在这篇概念性文章中，我们描述了一种逐步开发和全面验证实验室生物标志物的方法。我们将阐述包括技术性能、分析前问题和生物学变异等基本步骤，以及生物标志物效用的高级方面，包括可解释性、诊断和预后准确性以及医疗保健结果。这些方面将通过免疫学领域的知名例子进行说明。这一概念框架的应用将指导研究人员开展有意义的项目，以开发和评估用于临床实践的生物标志物。此外，临床医生将能够充分解读临床前和临床诊断文献，并在临床实践中合理应用生物标志物。生物标志物实施和应用的改进可能会显著改善我们患者的管理和治疗结果。
