Clinical performance of scalable automated p‐tau 217 multi‐analyte algorithmic blood test with reduced intermediate zone using multiplexed digital immunoassay
We developed a multi-analyte blood test for assessing brain amyloid status that significantly minimizes the ambiguous "intermediate zone," a key limitation of plasma phosphorylated tau (p-tau) 217 alone.Our test combines plasma levels of p-tau 217, amyloid beta 42/40 ratio, glial fibrillary acidic protein, and neurofilament light chain for a more comprehensive evaluation of amyloid status.We rigorously validated the test's clinical performance in > 1000 samples from symptomatic individuals across three independent cohorts, using cerebrospinal fluid biomarkers and amyloid positron emission tomography as comparators.
Authors
- Patrick Sheehy
- Michele Wolfe
- Attila Vaskó (ORCID: https://orcid.org/0000-0002-3580-3079)
- Inge M.W. Verberk (ORCID: https://orcid.org/0000-0003-0341-7445)
- Karen Copeland (ORCID: https://orcid.org/0000-0002-6455-3283)
- Charlotte Elisabeth Teunissen (ORCID: https://orcid.org/0000-0002-4061-0837)
- Mike Miller
- David Wilson (ORCID: https://orcid.org/0000-0002-5198-7509)
- Meenakshi Khare
- Lyndal K. Hesterberg
Institutions
- Colorado Community College System (US)
- Amsterdam Neuroscience (NL)
- Quanterix (United States) (US)
- UCHealth Yampa Valley Medical Center (US)
Publication Details
- Journal
- Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring
- Published
- 2025-10-01
- DOI
- https://doi.org/10.1002/dad2.70215
- Citations
- 1
- Primary Topic
- Dementia and Cognitive Impairment Research
- Type
- article
- Field-Weighted Citation Impact
- 1.47
Funders
- Alzheimer's Association
- Alzheimer's Drug Discovery Foundation
- EU Joint Programme – Neurodegenerative Disease Research
- International Progressive MS Alliance
- Amsterdam University Medical Centers
- European Commission
- ZonMw
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek
- Alzheimer Nederland