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Analytical and clinical validation of a high accuracy fully automated digital immunoassay for plasma phospho-Tau 217 for clinical use in detecting amyloid pathology
Wilson D, Khare M, Triana-Baltzer G, Wolfe M, Sheehy P, Copeland K, Hesterberg L, Vasko AJ et al.. Frontiers in neurology, 2025-07-09
Topic: Amyloid, tau and blood-test diagnosis
Background With the emergence of disease-modifying therapies for Alzheimer's disease (AD), there is an urgent need for scalable, accurate, and well-validated blood test alternatives to positron emission topography (PET) and lumbar punctures for identifying amyloid pathology to facilitate identification of candidates for therapy. Plasma p-Tau 217 has emerged as a plasma-based biomarker with sufficient sensitivity and specificity to both rule out and rule in amyloid pathology with high confidence, potentially serving as a readily scalable non-invasive test to aid AD diagnosis. In this report, we describe robust analytical and clinical validation of a lab developed test for plasma p-Tau 217 suitable for clinical diagnostic use. Methods A high sensitivity digital immunoassay using single molecule array (Simoa) technology was developed for plasma p-Tau 217 utilizing a 2-cutoff approach. The assay was analytically validated with industry standard protocols and clinically validated across 873 symptomatic individuals from two independent clinical cohorts using PET or cerebrospinal fluid (CSF) biomarkers as comparators. Results The assay exhibited acceptable analytical characteristics with an analytical sensitivity enabling measurement of plasma p-Tau 217 in all clinical samples. Excluding results between the two cutoffs, clinical sensitivity, specificity, and agreement with comparator methods (accuracy) were >90%, with 30.9% of the samples falling in the intermediate zone between the two cutoffs. Discussion The performance characteristics of the Simoa p-Tau 217 assay align with current accuracy recommendations for blood-based biomarker test performance for diagnostic use, making the test suitable for clinical use under the Clinical Laboratory Improvement Act (CLIA) as a diagnostic plasma test to aid in Alzheimer's diagnosis.
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APA 7th
Wilson, D., Khare, M., Triana-Baltzer, G., Wolfe, M., Sheehy, P., Copeland, K., et al. (2025). Analytical and clinical validation of a high accuracy fully automated digital immunoassay for plasma phospho-Tau 217 for clinical use in detecting amyloid pathology. Frontiers in neurology. https://doi.org/10.3389/fneur.2025.1568971
Vancouver
Wilson D, Khare M, Triana-Baltzer G, Wolfe M, Sheehy P, Copeland K, et al. Analytical and clinical validation of a high accuracy fully automated digital immunoassay for plasma phospho-Tau 217 for clinical use in detecting amyloid pathology. Frontiers in neurology. 2025. doi:10.3389/fneur.2025.1568971. PMID: 40708958.
BibTeX
@article{wilson2025-40708958,
author = {Wilson, D. and Khare, M. and Triana-Baltzer, G. and Wolfe, M. and Sheehy, P. and Copeland, K. and Hesterberg, L. and Vasko, A. J. and others},
title = {{Analytical and clinical validation of a high accuracy fully automated digital immunoassay for plasma phospho-Tau 217 for clinical use in detecting amyloid pathology}},
journal = {Frontiers in neurology},
year = {2025},
doi = {10.3389/fneur.2025.1568971},
pmid = {40708958},
url = {https://doi.org/10.3389/fneur.2025.1568971}
}
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Key findings
- Results The assay exhibited acceptable analytical characteristics with an analytical sensitivity enabling measurement of plasma p-Tau 217 in all clinical samples.
- Excluding results between the two cutoffs, clinical sensitivity, specificity, and agreement with comparator methods (accuracy) were >90%, with 30.9% of the samples falling in the intermediate zone between the two cutoffs.
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Study details
- Effect size30.9%
- Evidence strengthLow
How this study scored 48/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, studied in people and randomised / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multi-centre collaboration, so those were left out: it earned 28 of the 58 points we could judge it on, which is 48 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Frontiers in neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| 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 | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 40708958) |
| Free to read | 2 / 2 | Free to read |
| Points | 28 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 28 of the 58 points we could judge it on is 48 out of 100. |
| Total | 48 / 100 | — |
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