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Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays
Figdore DJ, Griswold M, Bornhorst JA, Graff-Radford J, Ramanan VK, Vemuri P, Lowe VJ, Knopman DS et al.. Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024-07-19
Topic: Plasma and spinal-fluid biomarkers
Introduction We aimed to evaluate clinical interpretation cutpoints for two plasma phosphorylated tau (p-tau)217 assays (ALZpath and Lumipulse) as predictors of amyloid status for implementation in clinical practice. Methods Clinical performance of plasma p-tau217 against amyloid positron emission tomography status was evaluated in participants with mild cognitive impairment or mild dementia (n = 427). Results Using a one-cutpoint approach (negative/positive), neither assay achieved ≥ 90% in both sensitivity and specificity. A two-cutpoint approach yielding 92% sensitivity and 96% specificity provided the desired balance of false positives and false negatives, while categorizing 20% and 39% of results as indeterminate for the Lumipulse and ALZpath assays, respectively. Discussion This study provides a systematic framework for selection of assay-specific cutpoints for clinical use of plasma p-tau217 for determination of amyloid status. Our findings suggest that a two-cutpoint approach may have advantages in optimizing diagnostic accuracy while minimizing potential harm from false positive results. Highlights Phosphorylated tau (p-tau)217 cutpoints for detection of amyloid pathology were established. A two-cutpoint approach exhibited the best performance for clinical laboratory use. p-tau217 assays differed in the percentage of results categorized as intermediate.
Key findings
- Results Using a one-cutpoint approach (negative/positive), neither assay achieved ≥ 90% in both sensitivity and specificity.
- A two-cutpoint approach yielding 92% sensitivity and 96% specificity provided the desired balance of false positives and false negatives, while categorizing 20% and 39% of results as indeterminate for the Lumipulse and ALZpath assays, respectively.
- Our findings suggest that a two-cutpoint approach may have advantages in optimizing diagnostic accuracy while minimizing potential harm from false positive results.
- A two-cutpoint approach exhibited the best performance for clinical laboratory use. p-tau217 assays differed in the percentage of results categorized as intermediate.
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Study details
- Participants427
- Evidence strengthLow
How this study scored 57/100
Published in a leading specialty journal. Scored zero for study design, effect reported 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 | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia : the journal of the Alzheimer's Association) |
| 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 | 427 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| 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 39030981) |
| 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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APA 7th
Figdore, D. J., Griswold, M., Bornhorst, J. A., Graff-Radford, J., Ramanan, V. K., Vemuri, P., et al. (2024). Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays. Alzheimer's & dementia : the journal of the Alzheimer's Association. https://doi.org/10.1002/alz.14140
Vancouver
Figdore DJ, Griswold M, Bornhorst JA, Graff-Radford J, Ramanan VK, Vemuri P, et al. Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2024. doi:10.1002/alz.14140. PMID: 39030981.
BibTeX
@article{figdore2024-39030981,
author = {Figdore, D. J. and Griswold, M. and Bornhorst, J. A. and Graff-Radford, J. and Ramanan, V. K. and Vemuri, P. and Lowe, V. J. and Knopman, D. S. and others},
title = {{Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays}},
journal = {Alzheimer's \& dementia : the journal of the Alzheimer's Association},
year = {2024},
doi = {10.1002/alz.14140},
pmid = {39030981},
url = {https://doi.org/10.1002/alz.14140}
}
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