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Development of a Plasma Biomarker Diagnostic Model Incorporating Ultrasensitive Digital Immunoassay as a Screening Strategy for Alzheimer Disease in a Chinese Population
Wu X, Xiao Z, Yi J, Ding S, Gu H, Wu W, Luo J, Liang X et al.. Clinical chemistry, 2021-11-01
Topic: Amyloid, tau and blood-test diagnosis
Background The ultrasensitive detection of blood-based biomarkers such as amyloid β (Aβ), tau, and neurofilament light (NFL) has drawn much attention in Alzheimer disease (AD) diagnosis. However, few studies have been conducted in the Chinese population. This study aimed to evaluate the ability of plasma biomarker diagnostic models for AD in the Chinese population based on a novel digital immunoassay technology. Methods 159 patients with AD, 148 patients with amnestic mild cognitive impairment (aMCI), and 121 cognitively normal control participants were recruited from 2 cohorts. The concentrations of plasma Aβ42, Aβ40, Aβ42/Aβ40, total tau (t-tau), phosphorylated tau 181 (p-tau 181), and NFL were quantified using an ultrasensitive single molecule array (Simoa) platform. Comprehensive and simplified diagnostic models were established based on the plasma biomarker profile and clinical characteristics. Results Among all blood biomarkers, p-tau181 had the greatest potential for identifying patients with cognitive impairment. The simplified diagnostic model, which combined plasma p-tau181, Aβ42, and clinical features, achieved 93.3% area under the curve (AUC), 78.6% sensitivity, and 94.2% specificity for distinguishing AD from control participants, indicating a diagnostic ability approaching that of the comprehensive diagnostic model including 5 plasma biomarkers and clinical characteristics (95.1% AUC, 85.5% sensitivity, 94.2% specificity). Moreover, the simplified model reached 95.9% AUC and 94.0% AUC for early- and late-onset AD/control participants, respectively. Conclusions We established AD diagnostic models using plasma biomarkers for Chinese participants. These findings suggest the simplified diagnostic model provides an accessible and practical way for large-scale screening in the clinic and community, especially in developing countries.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Wu, X., Xiao, Z., Yi, J., Ding, S., Gu, H., Wu, W., et al. (2021). Development of a Plasma Biomarker Diagnostic Model Incorporating Ultrasensitive Digital Immunoassay as a Screening Strategy for Alzheimer Disease in a Chinese Population. Clinical chemistry. https://doi.org/10.1093/clinchem/hvab192
Vancouver
Wu X, Xiao Z, Yi J, Ding S, Gu H, Wu W, et al. Development of a Plasma Biomarker Diagnostic Model Incorporating Ultrasensitive Digital Immunoassay as a Screening Strategy for Alzheimer Disease in a Chinese Population. Clinical chemistry. 2021. doi:10.1093/clinchem/hvab192. PMID: 34662373.
BibTeX
@article{wu2021-34662373,
author = {Wu, X. and Xiao, Z. and Yi, J. and Ding, S. and Gu, H. and Wu, W. and Luo, J. and Liang, X. and others},
title = {{Development of a Plasma Biomarker Diagnostic Model Incorporating Ultrasensitive Digital Immunoassay as a Screening Strategy for Alzheimer Disease in a Chinese Population}},
journal = {Clinical chemistry},
year = {2021},
doi = {10.1093/clinchem/hvab192},
pmid = {34662373},
url = {https://doi.org/10.1093/clinchem/hvab192}
}
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Key findings
- Results Among all blood biomarkers, p-tau181 had the greatest potential for identifying patients with cognitive impairment.
- These findings suggest the simplified diagnostic model provides an accessible and practical way for large-scale screening in the clinic and community, especially in developing countries.
Why it matters
In a Chinese population, among all blood biomarkers p-tau181 had the greatest potential for identifying patients with cognitive impairment, and a simplified model combining plasma p-tau181, Aβ42, and clinical features achieved 93.3% area under the curve, 78.6% sensitivity, and 94.2% specificity for distinguishing Alzheimer disease from controls. The authors suggest this simplified diagnostic model provides an accessible and practical way for large-scale screening, but it concerns diagnosis rather than treatment, cure, or prevention.
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Study details
- Participants159
- Effect size93.3%; 78.6%; 94.2%
- Evidence strengthLow
How this study scored 51/100
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 (Clinical chemistry) |
| Journal's citation record | 3 / 4 | Clinical Chemistry: journal h-index 323 (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 | 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 | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 159 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 | 4 / 7 | Cited 43 times (OpenAlex, 2026-10-10) |
| Citations per year | 2 / 5 | 6.1 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 3 / 6 | Cited 5.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 3 other studies in this library |
| Still being cited | 2 / 4 | Cited 27 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Ding Ding: h-index 39 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | Shanghai Jiao Tong University: institution h-index 975 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 4 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34662373) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Total | 51 / 100 | — |
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