生物标志物在自身免疫领域的合理开发和应用:指导临床医生和研究人员的概念框架

IF 4.7 Q2 IMMUNOLOGY
Mirjam Kolev , Michael P. Horn , Nasser Semmo , Michael Nagler
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引用次数: 0

摘要

在医学实验室生物标志物的开发和实施中需要明确的指导。到目前为止,还没有建立标准化的分阶段方法来指导研究人员和临床医生在这一过程中进行试验。这导致生物标记物经常不完全验证,这可能承担错误应用的后果,在临床环境中误解和管理不足。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。我们将描述基本步骤,包括技术性能、分析前问题和生物变异,以及生物标志物实用的高级方面,包括可解释性、诊断和预后准确性以及医疗保健结果。这些方面将通过使用免疫学领域的著名例子来说明。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释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。生物标志物的实施和应用的改进可能会改变我们患者的管理和预后。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Rational development and application of biomarkers in the field of autoimmunity: A conceptual framework guiding clinicians and researchers

Rational development and application of biomarkers in the field of autoimmunity: A conceptual framework guiding clinicians and researchers

Rational development and application of biomarkers in the field of autoimmunity: A conceptual framework guiding clinicians and researchers

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.

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来源期刊
Journal of Translational Autoimmunity
Journal of Translational Autoimmunity Medicine-Immunology and Allergy
CiteScore
7.80
自引率
2.60%
发文量
33
审稿时长
55 days
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