Critical Steps to be Taken into Consideration Before Quantification of β-Amyloid and Tau Isoforms in Blood can be Implemented in a Clinical Environment.

This review aims to document difficulties, limitations, and pitfalls when considering protein analysis in blood samples. It proposes an improved workflow for design, development, and validation of (immuno)assays for blood proteins, without providing reflections on a potential hypothesis of the origin of protein mismetabolism and deposition. There is a special focus on assay development for quantification of β-amyloid (Aβ) and tau in blood for diagnostic use or for integration in clinical trials in the field of Alzheimer's disease (AD).