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Clinical evaluation of a novel plasma pTau217 electrochemiluminescence immunoassay in Alzheimer's disease
Kivisäkk P, Fatima HA, Cahoon DS, Otieno B, Chacko L, Minooei F, Demos C, Stengelin M et al.. Scientific reports, 2024-01-05
Topic: Amyloid, tau and blood-test diagnosis
A growing literature suggests that plasma levels of tau phosphorylated at amino acid 217 (pTau217) performs similarly to cerebrospinal fluid (CSF) biomarkers and PET imaging to detect amyloid pathology and to provide diagnostic and prognostic information in Alzheimer's disease (AD), but a significant limiting factor thus far has been a lack of widely available immunoassays. We evaluated a novel pTau217 S-PLEX® assay developed by Meso Scale Discovery (MSD; Rockville, MD) in plasma from 131 individuals with AD confirmed by CSF biomarkers and controls. Technical performance of the assay was excellent with an LLOQ of 1.84 pg/mL and intra/interplate CVs of 5.5% (0.3-15.0%) and 5.7% (range 0.3-13.4%), respectively. The pTau217 plasma assay differentiated AD and controls with an AUC of 0.98 (95% CI 0.96-1.0) and pTau217 levels were 3.9-fold higher in individuals with AD. This performance was significantly better than what was observed for plasma pTau181, performed in parallel, and comparable to published data on existing pTau217 assays. While further clinical validation and head-to-head comparisons are needed to fully establish the role for the novel pTau217 S-PLEX assay, these data demonstrate the utility of the assay to detect AD pathology.
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APA 7th
Kivisäkk, P., Fatima, H. A., Cahoon, D. S., Otieno, B., Chacko, L., Minooei, F., et al. (2024). Clinical evaluation of a novel plasma pTau217 electrochemiluminescence immunoassay in Alzheimer's disease. Scientific reports. https://doi.org/10.1038/s41598-024-51334-x
Vancouver
Kivisäkk P, Fatima HA, Cahoon DS, Otieno B, Chacko L, Minooei F, et al. Clinical evaluation of a novel plasma pTau217 electrochemiluminescence immunoassay in Alzheimer's disease. Scientific reports. 2024. doi:10.1038/s41598-024-51334-x. PMID: 38182740.
BibTeX
@article{kivisakk2024-38182740,
author = {Kivisäkk, P. and Fatima, H. A. and Cahoon, D. S. and Otieno, B. and Chacko, L. and Minooei, F. and Demos, C. and Stengelin, M. and others},
title = {{Clinical evaluation of a novel plasma pTau217 electrochemiluminescence immunoassay in Alzheimer's disease}},
journal = {Scientific reports},
year = {2024},
doi = {10.1038/s41598-024-51334-x},
pmid = {38182740},
url = {https://doi.org/10.1038/s41598-024-51334-x}
}
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Key findings
- A growing literature suggests that plasma levels of tau phosphorylated at amino acid 217 (pTau217) performs similarly to cerebrospinal fluid (CSF) biomarkers and PET imaging to detect amyloid pathology and to provide diagnostic and prognostic information in Alzheimer's disease (AD), but a significant limiting factor thus far has been a lack of widely available immunoassays.
- This performance was significantly better than what was observed for plasma pTau181, performed in parallel, and comparable to published data on existing pTau217 assays.
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Study details
- Participants131
- Effect size5.5%; 15.0%; 5.7%
- Evidence strengthLow
How this study scored 57/100
Published in a peer-reviewed journal. Scored zero for study design 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 33 of the 58 points we could judge it on, which is 57 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Scientific reports) |
| 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 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 2 / 4 | 131 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 | — / 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 38182740) |
| Free to read | 2 / 2 | Free to read |
| Points | 33 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 33 of the 58 points we could judge it on is 57 out of 100. |
| Total | 57 / 100 | — |
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