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Analytical validation and amyloid-status discrimination of a high-throughput, research-use-only plasma p-Tau217 immunoassay
Wynveen, P.; Becker, A.; Levin, S.; Dumke, B.; Hoekstra, N.; Hoffmann, K.; Knutson, C.; Lengfeld et al.. medRxiv (preprint), 2026-09-02
Topic: Amyloid, tau and blood-test diagnosis
BackgroundPlasma phosphorylated tau at threonine 217 (p-Tau217) is a leading blood-based biomarker for Alzheimers disease (AD). Robust analytical characterization on high-throughput platforms is essential for research use and clinical translation. ObjectiveTo evaluate the analytical performance of an automated plasma p-Tau217 immunoassay and characterize its discrimination of PET-defined amyloid status. MethodsWe performed analytical validation of the Access Research Use Only (RUO) plasma p-Tau217 immunoassay on the Beckman Coulter DxI 9000 Access Immunoassay Analyzer and evaluated biomarker discrimination of PET-defined amyloid pathology in a subset of the Bio-Hermes-001 cohort spanning the symptomatic cognitive continuum (mild cognitive impairment or mild AD dementia; cognitively unimpaired participants excluded; n = 449). Analytical precision, sensitivity, linearity, specificity, interference, and sample stability were assessed per Clinical and Laboratory Standards Institute guidelines. Discrimination of PET-defined amyloid status was evaluated using receiver operating characteristic curve and indeterminate zone analyses. ResultsThe assay demonstrated high precision (within-laboratory CV [≤]7.1%), excellent sensitivity (limit of detection 0.018-0.021 pg/mL), linearity across the analytical measuring range (R{superscript 2} > 0.99), strong epitope specificity ([≤]1.0% cross-reactivity with other tau phosphoisoforms), and minimal interference from over 60 endogenous and exogenous substances. In 449 research participants plasma p-Tau217 showed strong discrimination between amyloid-positive and amyloid-negative groups (AUC 0.881; 95% CI 0.846-0.915). Application of indeterminate zones systematically improved classification metrics at the cost of fewer definitive classifications. ConclusionsThese findings support the Access p-Tau217 (RUO) assay as a robust, high-throughput assay for plasma biomarker-based discrimination of PET-defined amyloid pathology in AD applications.
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APA 7th
Wynveen, P., Becker, A., Levin, S., Dumke, B., Hoekstra, N., Hoffmann, K., et al. (2026). Analytical validation and amyloid-status discrimination of a high-throughput, research-use-only plasma p-Tau217 immunoassay. medRxiv (preprint). https://doi.org/10.64898/2026.08.31.26361836
Vancouver
Wynveen P, Becker A, Levin S, Dumke B, Hoekstra N, Hoffmann K, et al. Analytical validation and amyloid-status discrimination of a high-throughput, research-use-only plasma p-Tau217 immunoassay. medRxiv (preprint). 2026. doi:10.64898/2026.08.31.26361836.
BibTeX
@article{wynveen2026-fa2a3d2c,
author = {Wynveen, P. and Becker, A. and Levin, S. and Dumke, B. and Hoekstra, N. and Hoffmann, K. and Knutson, C. and Lengfeld and others},
title = {{Analytical validation and amyloid-status discrimination of a high-throughput, research-use-only plasma p-Tau217 immunoassay}},
journal = {medRxiv (preprint)},
year = {2026},
doi = {10.64898/2026.08.31.26361836},
url = {https://doi.org/10.64898/2026.08.31.26361836}
}
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Key findings
- ResultsThe assay demonstrated high precision (within-laboratory CV [≤]7.1%), excellent sensitivity (limit of detection 0.018-0.021 pg/mL), linearity across the analytical measuring range (R{superscript 2} > 0.99), strong epitope specificity ([≤]1.0% cross-reactivity with other tau phosphoisofo
Why it matters
This study validated an automated blood test for p-Tau217 and assessed how well it distinguished PET-defined amyloid status in people with mild cognitive impairment or mild Alzheimer's dementia. It is a laboratory test evaluation and does not test any treatment, cure or prevention.
New to this subject? Start with our plain-English guide: Blood tests & biomarkers →
Study details
- Participants449
- Effect size7.1%; 1.0%; AUC 0.881
- Evidence strengthModerate
How this study scored 16/100
Preprint — not yet peer-reviewed. It scored 33 on the same rubric, but non-peer-reviewed sources are capped at 16, so it shows as 16. Scored zero for study design and randomised / blinded because the record does not state it. We have no data on impact for its field and year, so that was left out: it earned 31 of the 94 points we could judge it on, which is 33 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (medRxiv (preprint)) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 3 / 5 | Rated “moderate” in our summary |
| Peer-review validation | 4 / 10 | Preprint — not yet peer-reviewed. Hosted on a preprint server. |
| How recent | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 2 / 4 | 449 participants |
| Effect reported | 3 / 3 | Effect reported with a statistic (interval, p-value, ratio or similar) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 0 / 7 | Cited 0 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.0 citations a year over 2 year(s) since 2026 |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 0 / 4 | Cited 0 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Jeremiah S. Hinson: h-index 29 (OpenAlex, whole career) |
| Institution's track record | 2 / 3 | Johns Hopkins University: institution h-index 2,306 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 9 institution(s) in 3 countries |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | 2 / 2 | Free to read |
| Points | 31 / 94 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 31 of the 94 points we could judge it on is 33 out of 100. |
| Total | 33 / 100 | Capped to 16 because this is not a peer-reviewed article. |
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