ArticleDiagnostics (Basel, Switzerland)2024
PrecivityAD2™ Blood Test: Analytical Validation of an LC-MS/MS Assay for Quantifying Plasma Phospho-tau217 and Non-Phospho-tau217 Peptide Concentrations That Are Used with Plasma Amyloid-β42/40 in a Multianalyte Assay with Algorithmic Analysis for Detecting Brain Amyloid Pathology.
Article in Diagnostics (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Plasma eMTBR-tau243 as a disease biomarker across Alzheimer's disease clinical phenotypes.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Prognostic value of plasma %p-tau217 in cognitively unimpaired older adults.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Associations between self-reported change in lifestyle behaviors and brain health: Findings from the Healthy Brain Initiative.Journal of Alzheimer's disease : JAD · 2026Article
- Navigating Challenges in Mass Spectrometry Analysis of Endogenous and Synthetic Protein Modifications.Biomolecules · 2026Review
- Amyloid Probability in Alzheimer Disease From Plasma, Cerebrospinal Fluid, and Amyloid Imaging.Research square · 2026Article
- Urinary acetylated protein as a biomarker of lupus nephritis: a prospective cohort study.Arthritis research & therapy · 2025Article
- Implementation of an Alzheimer's Disease Blood Test: Adoption Experience by Memory Care Specialists in a Multi-Center Study.Journal of personalized medicine · 2025Article
- Current Methods in Clinical Alzheimer's Disease Research and Diagnosis.Molecular diagnosis & therapy · 2025Review
- Prospective evaluation of plasma pTauAlzheimer's research & therapy · 2025Article
- Clinical Utility of an Alzheimer's Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study.Diagnostics (Basel, Switzerland) · 2025Article
- Independent validation of the PrecivityAD2™ blood test to identify presence or absence of brain amyloid pathology in individuals with cognitive impairment.NPJ dementia · 2025Article
- Article
- Racial and ethnic differences in plasma p-tau217 ratio biomarker eligibility rates in a preclinical AD trial with lecanemab.Alzheimer's & dementia (Amsterdam, Netherlands)Article
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Authors and funding
11 authors.
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Abstract
Alzheimer's disease (AD) is a progressive irreversible neurodegenerative disorder that represents a major global public health concern. Traditionally, AD is diagnosed using cerebrospinal fluid biomarker analysis or brain imaging modalities. Recently, less burdensome, more widely available blood biomarker (BBM) assays for amyloid-beta (Aβ42/40) and phosphorylated-tau concentrations have been found to accurately identify the presence/absence of brain amyloid plaques and tau tangles and have helped to streamline AD diagnosis. However, few BBMs have been rigorously analytically validated. Herein, we report the analytical validation of a novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) multiplex method for quantifying plasma phosphorylated-tau217 (p-tau217) and non-phosphorylated-tau217 (np-tau217) peptide concentrations. We combined the p-tau217/np-tau217 concentrations ratio (%p-tau217) and the previously validated LC-MS/MS multiplex assay for plasma Aβ42/40 into a new multianalyte assay with algorithmic analysis (MAAA; PrecivityAD2™ test) that identifies brain amyloid status based on brain amyloid positron emission tomography. We found (a) the %p-tau217 assay is precise, accurate, sensitive, and linear over a wide analytical measurement range, and free from carryover and interference; (b) the pre-analytical specimen collection, processing, storage, and shipping conditions that maintain plasma tau peptide stability; and (c) using the measured analytical imprecision for plasma Aβ42/40 and p-tau217/np-tau217 levels in a worst-case scenario model, the PrecivityAD2 test algorithm for amyloid pathology classification changed for only 3.5% of participants from brain amyloid positive to negative, or from negative to positive. The plasma sample preparation and LC-MS/MS methods underlying the PrecivityAD2 test are suitable for use in the clinical laboratory and valid for the test's intended purpose: to aid in the diagnostic evaluation of individuals aged 55 and older with signs or symptoms of mild cognitive impairment or dementia.
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