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Head-to-head comparison of plasma biomarker assays across platforms for amyloid pathology in a multicenter cohort
Xinyi Lv, Kaiyuan Shen, Qianhua Zhao, Guoping Peng, Huayan Liu, Feng Gao, Xiaodong Pan, Wei Chen et al.. 中国科学通报：英文版, 2026-08-06
Topic: Amyloid, tau and blood-test diagnosis
Plain-language summary
With the advancement of anti-amyloid treatments for Alzheimer disease, accurate assays for amyloid-β (Aβ) pathology are essential. Plasma phosphorylated tau 217 (p-tau217) is a blood-based biomarker, but its performance varies across platforms, necessitating head-to-head comparisons. This multicenter study evaluated 9 plasma p-tau217 assays (6 including Aβ42 measurements) for detecting amyloid positron emission tomography (PET) positivity. The final analysis included 431 participants from 10 memory clinics in China (median age, 68.0 years; 61.7% women; 64.0% amyloid PET-positive): 30 cognitively unimpaired individuals, 230 with mild cognitive impairment, and 171 with dementia. All plasma samples underwent blinded, batch-matched testing in a central laboratory across chemiluminescence immunoassay (Fujirebio, Beckman, Vazyme, manufacturer A), single-molecule immunoassay (Quanterix, Lychix, iomicsBio, manufacturer B), and multiplex bead-based flow cytometric immunoassay (CellGene). Seven of the 9 assays showed acceptable performance (area under the curve [AUC] 0.899-0.930), whereas 2 showed lower performance (AUC <0.800; P < 0.001). Under a two-cutoff approach (90% sensitivity/90% specificity), these 7 high-performing assays yielded an intermediate zone of 2.8% to 13.7%. Performance remained robust in mild cognitive impairment and dementia subgroups. Adding Aβ42 showed assay- and population-dependent effects. Manufacturer-recommended and previously published cutoffs showed variable performance in this independent cohort. Several plasma p-tau217 assays demonstrated strong diagnostic accuracy for amyloid PET positivity in this cross-sectional memory-clinic cohort, although performance varied across platforms and cutoff transferability was limited. Further longitudinal studies with predefined clinical outcomes are needed to determine prognostic value and clinical utility.
What this study adds
Evidence grade: Moderate
This is a cross-sectional study of 431 participants. Seven of 9 plasma p-tau217 assays showed acceptable accuracy for detecting amyloid PET positivity, while 2 performed worse, and cutoff values did not transfer well between platforms. Reported effect size: 61.7%; 64.0%; 2.8% to 13.7%.
Taken from this record’s own fields, not from reading the paper. The grade is assigned from the abstract’s wording; what that means.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Lv, X., Shen, K., Zhao, Q., Peng, G., Liu, H., Gao, F., et al. (2026). Head-to-head comparison of plasma biomarker assays across platforms for amyloid pathology in a multicenter cohort. 中国科学通报：英文版. https://doi.org/10.1016/j.scib.2026.08.018
Vancouver
Lv X, Shen K, Zhao Q, Peng G, Liu H, Gao F, et al. Head-to-head comparison of plasma biomarker assays across platforms for amyloid pathology in a multicenter cohort. 中国科学通报：英文版. 2026. doi:10.1016/j.scib.2026.08.018. PMID: 42633973.
BibTeX
@article{lv2026-42633973,
author = {Lv, Xinyi and Shen, Kaiyuan and Zhao, Qianhua and Peng, Guoping and Liu, Huayan and Gao, Feng and Pan, Xiaodong and Chen, Wei and others},
title = {{Head-to-head comparison of plasma biomarker assays across platforms for amyloid pathology in a multicenter cohort}},
journal = {中国科学通报：英文版},
year = {2026},
doi = {10.1016/j.scib.2026.08.018},
pmid = {42633973},
url = {https://doi.org/10.1016/j.scib.2026.08.018}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
Key findings
- Several plasma p-tau217 assays demonstrated strong diagnostic accuracy for amyloid PET positivity in this cross-sectional memory-clinic cohort, although performance varied across platforms and cutoff transferability was limited.
Why it matters
Seven of 9 plasma p-tau217 assays showed acceptable accuracy for detecting amyloid PET positivity, while 2 performed worse, and cutoff values did not transfer well between platforms. This means blood biomarker results may not be comparable across different test platforms.
New to this subject? Start with our plain-English guide: Blood tests & biomarkers →
Study details
- Study designcross-sectional
- Participants431
- Effect size61.7%; 64.0%; 2.8% to 13.7%
- Evidence strengthModerate
How this study scored 52/100
Published in a peer-reviewed journal, and it is a snapshot of people at one point in time. Scored zero for randomized / blinded because the record does not state it. We have no data on journal's citation record, so that was left out: it earned 50 of the 96 points we could judge it on, which is 52 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (中国科学通报：英文版) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 4 / 12 | A snapshot of people at one point in time |
| 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 | 5 / 5 | 2026 — within 1 year(s) of the newest study here |
| Sample size | 2 / 4 | 431 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) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 1 / 7 | Cited 1 times (OpenAlex, 2026-10-10) |
| Citations per year | 0 / 5 | 0.5 citations a year over 2 year(s) since 2026 |
| Impact for its field and year | 3 / 6 | Cited 4.7× 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 1 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Jiong Shi: h-index 27 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Zhejiang University: institution h-index 1,040 (OpenAlex) |
| Multicenter collaboration | 3 / 3 | OpenAlex lists 20 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 42633973) |
| Free to read | 2 / 2 | Free to read |
| Points | 50 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 50 of the 96 points we could judge it on is 52 out of 100. |
| Total | 52 / 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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