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40/100

✓ Peer-reviewed alzhub usefulness score 40 out of 100. Biomarkers

Topic: Brain proteins, microglia and lab models

of 0.928 and bias of 6.0% (n =396, Deming regression, Figure 1). Percent recoveries across the analytical measuring range varied between 87.3-114.8%. Within-run precision across two imagers had CVs ranging from 3.3-6.3, 3.5-5.8 and 5.1-9.6% for high, mid and low p -tau217 concentrations, respectively. Within-laboratory CVs were 4.4-8.8, 4.8-6.9 and 9.3-12.4% for high, mid and low concentrations, respectively. The limit of detection was 0.04 U/mL. The limit of quantitation was established at 0.70 U/mL. p -tau217 protein stabilities were determined for minimums of 48 hours, 7 days, 2 weeks and 3 cycles for ambient, refrigerated, frozen (-20 °C) and freeze/thaw, respectively. Interference (outside ±20% from matrix-matched controls) was evident above 300 and 4.3 mg/dL for hemoglobin and bilirubin, respectively. Lipemia (1500 mg/dL), rheumatoid factor (99 IU/mL), a 47-analyte drug panel, p -tau181 (10 pg/mL), and human tau441 (20ng/mL) did not interfere with the assay. Analysis of positron emission tomography combined with p -tau217 results from individuals presenting with cognitive decline (n =524, ages 60-86 years), established cut-offs of Negative, <0.13 U/mL; Indeterminate, ≥0.13 to <0.20 U/mL; and Positive, ≥0.20 U/mL. The Quanterix SP-X Human p -tau217 immunoassay demonstrates acceptable performance for quantifying p -tau217 in human plasma. Results support the assay as an aid in the detection of AD pathology.

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APA 7th

Nelson, H. A., Erickson, J. A., La’ulu, S. L., Cunningham, S., & Doyle, K. J. (2025). Analytical validation of plasma p ‐tau217 on the SP‐X platform. Alzheimer s & Dementia. https://doi.org/10.1002/alz70861_108797

Vancouver

Nelson HA, Erickson JA, La’ulu SL, Cunningham S, Doyle KJ. Analytical validation of plasma p ‐tau217 on the SP‐X platform. Alzheimer s & Dementia. 2025. doi:10.1002/alz70861_108797. PMID: 41433607.

BibTeX

@article{nelson2025-41433607,
  author  = {Nelson, Heather A. and Erickson, J. Alan and La’ulu, Sonia L. and Cunningham, Sierra and Doyle, Kelly J.},
  title   = {{Analytical validation of plasma p ‐tau217 on the SP‐X platform}},
  journal = {Alzheimer s \& Dementia},
  year    = {2025},
  doi     = {10.1002/alz70861_108797},
  pmid    = {41433607},
  url     = {https://doi.org/10.1002/alz70861_108797}
}

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Key findings

of 0.928 and bias of 6.0% (n =396, Deming regression, Figure 1).
Percent recoveries across the analytical measuring range varied between 87.3-114.8%.
Within-run precision across two imagers had CVs ranging from 3.3-6.3, 3.5-5.8 and 5.1-9.6% for high, mid and low p -tau217 concentrations, respectively.
Within-laboratory CVs were 4.4-8.8, 4.8-6.9 and 9.3-12.4% for high, mid and low concentrations, respectively.
The limit of quantitation was established at 0.70 U/mL. p -tau217 protein stabilities were determined for minimums of 48 hours, 7 days, 2 weeks and 3 cycles for ambient, refrigerated, frozen (-20 °C) and freeze/thaw, respectively.

Why it matters

This study describes the analytical validation of a plasma p-tau217 test on one platform, showing acceptable performance for measuring p-tau217 in human plasma and establishing negative, indeterminate and positive cutoffs. The results support the assay as an aid in diagnosis, though this is a technical validation rather than a test of treatment or prevention.

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Study details

Participants396
Effect size6.0%; 114.8%; 9.6%
Evidence strengthModerate

How this study scored 40/100

Published in a peer-reviewed journal. Scored zero for study design and randomised / blinded because the record does not state it.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (Alzheimer s & Dementia)
Journal's citation record	2 / 4	Alzheimer s & Dementia: journal h-index 228 (OpenAlex, 2026-10-29)
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	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	2 / 4	396 participants
Effect reported	2 / 3	Effect reported as a number, without an interval or test
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 3 year(s) since 2025
Impact for its field and year	0 / 6	Cited 0.0× the average for papers of its field and year (OpenAlex FWCI)
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	1 / 4	Last-listed author Kelly J. Doyle: h-index 12 (OpenAlex, whole career)
Institution's track record	1 / 3	University of Utah: institution h-index 1,238 (OpenAlex)
Multi-centre collaboration	1 / 3	OpenAlex lists 3 institution(s) in 1 country
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 41433607)
Free to read	2 / 2	Free to read
Total	40 / 100	—

What each of these 20 components measures, and what this score is not →

Read the original

Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).

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