Evidence map›Paper›PMID 41457950›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2025

False positive plasma p-tau217 results associated with heterophilic antibody interference: A potential clinical pitfall.

Alicia Algeciras-Schimnich, J Paul Theobald, Daniel J Figdore, Susan Ashrafzadeh Kian, Joshua A Bornhorst

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Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

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0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Alicia Algeciras-SchimnichDepartment of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-4455-6217
J Paul TheobaldDepartment of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Daniel J FigdoreDepartment of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Susan Ashrafzadeh KianDepartment of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Joshua A BornhorstDepartment of Laboratory Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPlasma phosphorylated tau at threonine 217 (p-tau217) has emerged as one of the most promising blood-based biomarkers for Alzheimer's disease (AD). While rare, heterophilic antibodies (HAb) are a persistent potential confounding factor in immunoassays.

methodsPotential HAb interference in the Lumipulse G pTau217 assay in samples exhibiting concentrations > 10 pg/mL were investigated. Samples were subjected to HAb blocking reagent (HBT), and in some cases, polyethylene glycol (PEG) precipitation and serial dilutions.

resultsIn 14 of the 15 suspected HAb cases, HBT treatment greatly reduced measured p-tau217 concentrations. and in one of three specimens selected for further investigation, reduced Aβ42 concentrations PEG precipitation in the three selected samples also reduced p-tau217 concentrations, while serial dilution yielded mixed effects. Control specimens were unaffected by sample treatment or dilutions. DISCUSSION: HAb may result in falsely elevated p-tau217 and p-tau217/Aβ42 ratio. HAb interference should be considered in cases of unusually high p-tau217 concentrations prior to clinical interpretation. HIGHLIGHTS: Potential heterophile antibody (HAb) interference in the Lumipulse p-tau217 immunoassay was investigated. Investigation was performed using HAb blocking reagent, and in some cases also using PEG precipitation . Patients with p-tau217 concentrations > 10 pg/mL exhibited positive HAb interference in 14 of 15 cases. HAb interference can lead to falsely positive p-tau217/Aβ42 ratios.

Indexed as

Alzheimer DiseaseAntibodies, Heterophiletau ProteinsAgedAmyloid beta-PeptidesBiomarkersFalse Positive ReactionsFemaleHumansImmunoassayMalePeptide FragmentsPhosphorylationAmyloid beta-Peptidesamyloid beta-protein (1-42)Antibodies, HeterophileBiomarkersMAPT protein, humanPeptide Fragmentstau ProteinsFujirebio Lumipulse p‐tau217Heterophilic antibodiesImmunoassays

Identifiers

PMID41457950
PMCPMC12746040

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.