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Open Access 01-12-2019 | Alzheimer's Disease | Review

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

Authors: Hugo Marcel Vanderstichele, Charlotte E. Teunissen, Eugeen Vanmechelen

Published in: Neurology and Therapy | Special Issue 2/2019

Abstract

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).

A biomarker is an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. A biomarker is not an assessment of how a patient feels, functions, or survives (https://www.ncbi.nlm.nih.gov/books/NBK326791/pdf/Bookshelf_NBK326791.pdf).

Context of use: A statement that fully and clearly describes the way the medical product development tool is to be used and the medical product development-related purpose of the use. Intended use: The specific clinical circumstance or purpose for which a medical product or test is being developed. In the regulatory context, it refers to the objective intent of the persons legally responsible for the labeling of medical products (https://www.ncbi.nlm.nih.gov/books/NBK326791/pdf/Bookshelf_NBK326791.pdf).

A protein isoform is one of a number of different structurally similar proteins that are created as the result of alternative splicing or from similar genes formed from a copied gene and differentiated as the result of evolution.

Selectivity: extent to which the method can determine a particular compound in the analyzed matrices without interference from matrix components. Specificity: ability of the method to assess, unequivocally, the analyte in the presence of other components that are expected to be present (e.g., impurities, degradation products, matrix components, etc.). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biomarker-qualification-evidentiary-framework.

Accuracy: The degree of closeness of the determined value to the nominal or known true value under prescribed conditions.

https://www.fda.gov/media/70858/download.

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Title: Critical Steps to be Taken into Consideration Before Quantification of β-Amyloid and Tau Isoforms in Blood can be Implemented in a Clinical Environment
Authors: Hugo Marcel Vanderstichele
Charlotte E. Teunissen
Eugeen Vanmechelen
Publication date: 01-12-2019
Publisher: Springer Healthcare
Keywords: Alzheimer's Disease
Alzheimer's Disease
Biomarkers
Published in: Neurology and Therapy / Issue Special Issue 2/2019
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI: https://doi.org/10.1007/s40120-019-00166-3

At a glance: The STEP trials

Springer Medicine

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

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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A Review on MS-Based Blood Biomarkers for Alzheimer’s Disease

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