Biomarkers

Area of Science:

• Biochemistry
• Clinical Chemistry
• Biomarker Discovery

Background:

• High-quality biomarker services in GLP/GCP environments require understanding variables impacting test accuracy.
• Preclinical and clinical studies need robust neurobiomarker measurements.
• This study addresses the need for reliable quality control (QC) samples for neurobiomarker analysis.

Purpose of the Study:

• To detail an experimental protocol for creating QC samples for neurobiomarker measurements.
• To assess the stability of these QC samples in biological matrices.
• To ensure accuracy and robustness of biomarker test results in clinical studies.

Main Methods:

• Collected whole blood from healthy individuals, processed to EDTA-plasma within one hour.
• Measured baseline concentrations of Aß1-40, Aß1-42, pTau217, and NF-L using Lumipulse and Mesoscale Discovery platforms.
• Prepared Low and High concentration QC samples by spiking calibrants, then evaluated short-term (freeze/thaw, bench top) and long-term (-80°C) stability, including effects of hemolysis and hyperlipemia.

Main Results:

• Determined concentration ranges for each neurobiomarker in EDTA-plasma.
• Established acceptable intra- and inter-assay variability within ± 20%.
• Pooled EDTA-plasma QC samples showed deviations within ± 20% from nominal concentrations after stability testing.

Conclusions:

• Qualified an internal procedure for preparing QC samples for neurobiomarker testing.
• Evaluated the short-term and long-term stability of EDTA-plasma QC samples.
• Validated the use of these QC samples for biomarker testing in clinical trials.