Abstract
Developments in Alzheimer's disease blood-based biomarkers research have provided critical information as to their use in early detection and assessments of progression in patients. The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) Biomarker Assay Laboratory (BAL) was developed to provide expertise and access to robust and reliable research-use-only biomarkers (not for medical decision making) for the Alzheimer's disease and related dementias (ADRD) research community. The NCRAD BAL is a quality-focused laboratory delivering biomarker data through the use of highly standardized procedures and highly automated instrumentation with the goal of limiting pre-analytical variability while preparing samples for analysis, including limiting lot-to-lot variability of the assays. As biomarkers become United States Food and Drug Administration (FDA) -approved and move into use in CLIA labs, the NCRAD BAL will bring forward new platforms and assays reflecting the most current research-use-only biomarkers to support the research mandate of the ADRD research community. HIGHLIGHTS: The National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) has developed a Biomarker Assay Laboratory to support research of robust and reliable fluid biomarkers for Alzheimer's disease and neurodegeneration. NCRAD supports Alzheimer's Disease Research Centers by providing biomarker analyses on samples with clinical and imaging data through the National Institute on Aging (NIA) -funded Alzheimer's Disease Center Fluid Biomarker Initiative. The NCRAD Biomarker Assay Laboratory focuses on decreasing variability that will affect study results by utilizing highly standardized and automated procedures, strict monitoring of control measures, and controlling for lot-to-lot and instrument-to-instrument variability.