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Standardising P-tau Plasma Measurements: The NEuroBioStand Project

Abstract #175 Posted on26 March 202529 April 2025 29 April 2025 23h15

Author(s)

Chiara Giangrande (Presenting Author) | Laboratoire National de métrologie et d'essais (LNE) | 1 rue Gaston Boissier, 75015, Paris, France
Hélène Vaneeckhoutte | Laboratoire National de métrologie et d'essais (LNE) | 1 rue Gaston Boissier, 75015, Paris, France
Samy Messaoudi | Laboratoire National de métrologie et d'essais (LNE) | 1 rue Gaston Boissier, 75015, Paris, France
Vincent Delatour | Laboratoire National de métrologie et d'essais (LNE) | 1 rue Gaston Boissier, 75015, Paris, France
Joelle Vinh | Laboratoire de Spectrométrie de Masse Biologique et Protéomique, SMBP, UAR2051, ESPCI Paris, PSL University, CNRS | 10 rue Vauquelin Paris, 75005, Paris, France
Yann Verdier | Laboratoire de Spectrométrie de Masse Biologique et Protéomique, SMBP, UAR2051, ESPCI Paris, PSL University, CNRS | 10 rue Vauquelin Paris, 75005, Paris, France
Eugeen Vanmechelen | ADx Neurosciences | Technologiepark 6, 9052, Gent, Belgium
Peter Koertvelyessy | Charité-Universitätsmedizin Berlin | Charitéplatz 1, 10117 , Berlin, Germany
Kaj Blennow | University of Gothenburg | Klin Neurokemi Lab Hus V3, SU/Mölndals sjukhus, 431 80, Mölndal, Sweden
Johan Gobom | University of Gothenburg | Klin Neurokemi Lab Hus V3, SU/Mölndals sjukhus, 431 80, Mölndal, Sweden
Henrik Zetterberg | University of Gothenburg | Klin Neurokemi Lab Hus V3, SU/Mölndals sjukhus, 431 80, Mölndal, Sweden

Abstract

NEuroBioStand is an EU-funded project aiming at standardising the measurement of neurodegenerative diseases biomarkers by using new metrological strategies. One of the objectives is to establish traceability to SI units for P-tau plasma measurements in Alzheimer's disease by developing a candidate reference measurement procedure (RMP) with a target uncertainty of less than 15%. Prototype reference materials will be certified by using this method.

NEuroBioStand’s consortium has prioritized P-tau181, P-tau217 and P-tau231 as clinically-relevant biomarkers. P-tau calibrators have been characterised in terms of purity and mass fraction by amino acid analysis and LC-MS. In particular, the full characterisation of the phosphorylation status of an in vitro phosphorylated candidate primary calibrator has been carried out to determine the site occupancy of the most relevant phosphorylation sites by using the SI-traceable quantified phosphorylated peptide materials. The peptide and/or the protein calibration materials are being used for the development of an RMP in plasma, exploiting the potential of isotope dilution (ID) coupled to targeted mass spectrometry and nano liquid chromatography (nanoLC).

This work relies on the collaboration of national metrology institutes, clinicians, academics and IVD-providers under the umbrella of the IFCC-WG on Biomarkers of neurodegenerative diseases (IFCC-WG BND) with the final aim of standardising P-tau cut-off values and reference ranges.

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NEuroBioStand’s consortium has prioritized P-tau181, P-tau217 and P-tau231 as clinically-relevant biomarkers. P-tau calibrators have been characterised in terms of purity and mass fraction by amino acid analysis and LC-MS. In particular, the full characterisation of the phosphorylation status of an in vitro phosphorylated candidate primary calibrator has been carried out to determine the site occupancy of the most relevant phosphorylation sites by using the SI-traceable quantified phosphorylated peptide materials. The peptide and/or the protein calibration materials are being used for the development of an RMP in plasma, exploiting the potential of isotope dilution (ID) coupled to targeted mass spectrometry and nano liquid chromatography (nanoLC).

This work relies on the collaboration of national metrology institutes, clinicians, academics and IVD-providers under the umbrella of the IFCC-WG on Biomarkers of neurodegenerative diseases (IFCC-WG BND) with the final aim of standardising P-tau cut-off values and reference ranges.

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