The aim of this work package is to develop a reference measurement procedure (RMP) based on mass spectrometry for P-tau in plasma and candidate matrix-based reference materials (RMs) that can be used to standardise measurements of plasma P-tau and harmonise measurements between analytical platforms. Traceability to SI units will be achieved through the production of fully characterised protein and/or peptide primary calibrators. P-tau is currently included in the AT(N) framework for AD diagnosis together with other biomarkers and parameters of clinical relevance (determined by imaging) and allows to discriminate among AD and other form of dementia. The standardisation of the measurements for this biomarker will allow to establish cut-off values and reference ranges to apply to this framework.
Task.1.1 will develop a reference measurement procedure for the quantification of plasma P-tau.
Task.1.2 will establish SI-traceability for P-tau measurements in plasma through the use of prototype commutable matrix-based reference materials quantified by the reference measurement procedure developed in Task 1.1.
Task.1.3 will evaluate the potential for standardising immunoassays through commutable prototype candidate RMs or value assignment of reference method target values to panels of clinical specimens.
WP leader: Prof. Johan Gobom, Henrik Zetterberg, Kaj Blennow (UGOT).