Toward harmonized reporting of Alzheimer’s disease biomarkers in clinical practice
TL;DR
The principles of harmonized reporting for Alzheimer’s disease biomarkers and a structured framework for standardized clinical neurochemistry reports are discussed and a structured framework for standardized clinical neurochemistry reports is proposed.
Abstract
Abstract Cerebrospinal fluid biomarkers, and more recently blood-based biomarkers, are playing a pivotal role in reshaping the clinical management of neurodegenerative diseases, supporting early detection, biological diagnosis, patient stratification, prognostic assessment, therapeutic decision-making, and longitudinal disease monitoring. To effectively support clinical decision-making, biomarker measurements must be communicated in a standardized, transparent, and clinically interpretable manner. Despite international quality standards, considerable heterogeneity persists in reporting practices, including differences in terminology, units of measurement, analytical descriptions, reference frameworks, and interpretative comments, limiting comparability across laboratories and potentially affecting clinical decision-making. In this article, we discuss the principles of harmonized reporting for Alzheimer’s disease biomarkers and propose a structured framework for standardized clinical neurochemistry reports. We describe the essential components of a harmonized report, including report identification, analytical information, specification of analytical method and platform, standardized units of measurement, appropriate use of reference intervals and clinical decision thresholds, documentation of pre-analytical and quality-related factors, and evidence-based interpretative comments. We further discuss the importance of structured multimarker interpretation and the need to contextualize biomarker findings within the clinical scenario. Finally, we examine the role of harmonized reporting in promoting interoperability across healthcare systems, facilitating longitudinal patient monitoring, supporting electronic health records and standardized terminologies, and enabling artificial intelligence–driven clinical decision support. As neurodegenerative disease diagnostics continue to evolve and novel biomarkers and technologies emerge, harmonized reporting should be regarded as a critical component of laboratory quality, ensuring that analytical advances translate into consistent, clinically meaningful, and interoperable information that ultimately improves patient care.