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Standardisation of Alzheimer's biomarkers' testing

Vials of reference materials for the Alzheimer's biomarker Abeta42 Vials of reference materials for the Alzheimer's biomarker Abeta42
Sep 20 2017

 JRC scientists contributed to the validation of methods to quantify a promising marker for the diagnosis of Alzheimer's disease. This work is pivotal for the preparation of soon te be released certified reference materials based on cerebrospinal fluid proteins (CSF), enabling standardisation of tests for Alzheimer diagnosis.

The JRC works in close collaboration with the International Federation of Clinical Chemists (IFCC) Working Group on standardisation for CSF which defined developed two reference measurement procedures (RMPs) based on liquid chromatography-tandem mass spectrometry for the quantification of the 42 amino acid form of amyloid Aβ1-42 in CSF.

Both RMPs were tested in ring trials. Next to that, commutability studies were performed to identify suitable reference material formats. This led to the establishment of human CSF pools containing endogenous Aβ1-42 at three concentrations as potential Certified Reference Materials (CRMs).
This is a story in progress with important steps already accomplished which will lead in the near future to the standardization of measurements of Abeta42, a major marker for the early diagnosis of Alzheimer's disease.

With these tests accomplished, now the certification of three new CRMs for CSF measurements is underway.
Read more in: J. Kuhlmann et al.:  "CSF Aβ1-42 - an excellent but complicated Alzheimer's biomarker - a route to standardisation.",  Clin. Chim .Acta  467 (2017) 27-33, doi: 10.1016/j.cca.2016.05.014