Plasma Phosphorylated Tau 217 Cutoffs for Amyloid Pathology and Kidney Function, Body Mass Index, and Anemia
Open accessAbstract
Importance: Plasma phosphorylated p-tau 217 levels vary with biological factors such as kidney dysfunction, body mass index (BMI), and anemia. It remains unclear whether a biological subgroup–specific optimal cutoff or a double-cutoff strategy could enhance diagnostic accuracy and cost efficiency beyond the standard single cutoff. Objective: To compare the diagnostic and economic performance of 3 plasma p-tau217 classification strategies for detecting amyloid-β (Aβ) positivity: standard single cutoff, subgroup-specific optimal cutoff, and double cutoff. Design, Setting, and Participants: This cohort study was a multicenter cross-sectional study conducted from 2016 to 2023; analyses were completed in 2025. Participants were recruited from multiple memory clinics and community-based cohorts. All participants had amyloid positron emission tomography (PET) imaging, clinical evaluation, and p-tau217 testing with measures of estimated glomerular filtration rate (eGFR), BMI, and hemoglobin. Measurements of p-tau217 were made using UGOT Simoa and Roche Elecsys, and the %p-tau217 ratio was assessed using a tau multianalyte assay (C 2 N Diagnostics LLC). Exposures: Kidney function (chronic kidney disease [CKD], eGFR <60 mL/min/1.73 m 2 ; advanced CKD, eGFR <45 mL/min/1.73 m 2 ), underweight (BMI <18.5), obesity (BMI ≥27.5), and anemia (hemoglobin <12 g/dL in women, <13 g/dL in men). Main Outcomes and Measures: Plasma p-tau217 concentration; standard single cutoff, optimal cutoffs, and double cutoff for Aβ positivity (Centiloid ≥25.5); accuracy; and cost-effectiveness estimated from false-positive, false-negative, and confirmatory imaging costs. Results: A total of 2571 participants were analyzed with UGOT, 1578 with Roche, and 304 with the C2N %p-tau217 ratio. The mean (SD) age was similar across cohorts (71.3 [8.6] years in the UGOT cohort, 71.3 [8.5] years in the Roche cohort, and 71.8 [7.8] years in the C2N cohort); there were 1633 (63.5%), 1006 (63.8%), and 191 (62.8%) women and 938 (36.5%), 572 (36.2%), and 113 (37.2%) men, respectively. In the UGOT cohort, the optimal cutoff improved diagnostic accuracy compared with the standard single cutoff, particularly in CKD and anemia (CKD: from 0.65; 95% CI, 0.57-0.72; to 0.83; 95% CI, 0.76-0.89; anemia: from 0.80; 95% CI, 0.76-0.84; to 0.86; 95% CI, 0.82-0.90), with consistent findings in the Roche cohort. In all biological subgroups, the double-cutoff strategy also increased accuracy relative to the single cutoff and reduced false classifications but yielded 12% to 39% intermediate results. When compared directly, the optimal cutoff provided higher accuracy than the double cutoff for CKD while lowering total diagnostic costs. For anemia, the double cutoff showed slightly higher accuracy but required confirmatory PET in up to 25% of cases, offsetting its economic advantage. In obesity, the double cutoff remained superior for both diagnostic accuracy and cost efficiency. Conclusions and Relevance: This study found that both the optimal cutoff and the double-cutoff strategy outperformed the standard single cutoff, each showing distinct strengths across subgroups. These findings support biologically informed thresholds to improve diagnostic accuracy and cost efficiency when implementing plasma p-tau217.
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Amyloid positivity in AD patients is associated with substantially accelerated increases in ptau-217, with prospective longitudinal studies demonstrating a six-fold higher annual increase in plasma ptau-217 in amyloid-positive versus amyloid-negative individuals.
“In contrast, amyloid positivity in AD patients is associated with substantially accelerated increases in ptau-217, with prospective longitudinal studies demonstrating a six-fold higher annual increase in plasma ptau-217 in amyloid-positive versus amyloid-negative individuals (16,23,26).”
From Amyloid-Independent Elevation of Plasma phosphorylated tau-217 Tracks Neurodegenerative Risk in Tuberous Sclerosis Complex: Implications for mTOR-Targeted Intervention (2026) · cites this paper as [26]
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredChronic kidney disease is associated with increased plasma p-tau levels independent of age or AD pathology, likely reflecting reduced peripheral clearance rather than increased central production, as cerebrospinal fluid tau does not show parallel elevations.
“CKD, which is common in TSC, has been associated with increased plasma p-tau levels independent of age or AD pathology, likely reflecting reduced peripheral clearance rather than increased central production, as cerebrospinal fluid tau does not show parallel elevations (26,28).”
From Amyloid-Independent Elevation of Plasma phosphorylated tau-217 Tracks Neurodegenerative Risk in Tuberous Sclerosis Complex: Implications for mTOR-Targeted Intervention (2026) · cites this paper as [26]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredUnderweight status and anemia have been reported to influence plasma ptau-217 independent of amyloid status.
“Additional biological factors, including underweight status and anemia, have been reported to influence plasma ptau-217 independent of amyloid status (26).”
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- Authors
- Yun, J., Lee, J., Shin, D., Lee, E. H., Kim, J. P., Ham, H., Gu, Y., Chun, M. Y., Kang, S. H., Kim, H. J., Na, D. L., Kim, K. W., Kim, S. E., Kim, Y., Kim, J., Jung, N.-Y., Kim, Y. J., Cho, S. H., Lee, J. S., Kim, S., Zetterberg, H., Blennow, K., Gonzalez-Ortiz, F., Ashton, N. J., Braunstein, J. B., Verghese, P. B., West, T., Meyer, M. R., Seo, S. W., Jang, H., Groups, K.-R. S., Kim, Y., Han, S.-H., Seong, J., Choi, J.-K., Lee, E.-S., Lee, T.-K., Chin, J., Kim, C.-H., Kim, H. J., Bok, H., Kim, H.-R., Kim, S. J., Na, S., Kim, G. H., Lee, J. S., Cho, H., Kim, B. C., Lee, D. Y., Moon, S. Y., Byun, M. S., Jung, G., Yi, D., Lee, H. N., Jang, J.-W., Jeong, J. H., Jung, Y. H., Kim, J. H., Kim, Y., Cheon, B. K., Seo, J., Noh, Y., Yang, H., Ha, Y., Shin, H.-E., Kang, K., Eom, S., Shin, K. Y., Kim, Y., Jang, J., Yoon, C., Lee, D. K., Ham, H., Park, Y. H., Kim, S.-J., Byun, B., Choi, Y., Lee, N. K., Won, H.-H., Cho, M., Jung, S.-H., Lee, D. H., & Kim, B.
- Affiliations
- Kyung Hee University (KR)
- Alzheimer’s Disease Convergence Research Center, Samsung Medical Center, Seoul, South Korea
- Samsung Medical Center (KR)
- Hallym University (KR)
- Yonsei University (KR)
- Korea University Guro Hospital (KR)
- Jeonbuk National University Hospital (KR)
- Department of Neurology, Inje University College of Medicine, Haeundae Paik Hospital, Busan, Korea
- Kangwon National University (KR)
- Pusan National University Yangsan Hospital (KR)
- Department of Neurology, Kangdong Sacred Heart Hospital, Seoul, Republic of Korea
- Chonnam National University (KR)
- Sahlgrenska University Hospital (SE)
- University of Science and Technology of China (CN)
- Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden
- King's College London (GB)
- C2N Diagnostics (United States) (US)
- Asan Medical Center (KR)
- for the K-ROAD Study Groups
- Corresponding author
- Seo, Sang Won
- Jang, Hyemin
- ORCID
- Shin, Daeun
- Lee, Eun Hye
- Kim, Jun Pyo
- Gu, Yuna
- Chun, Min Young
- Kim, Ko Woon
- Kim, Yeshin
- Kim, Jaeho
- Jung, Na-Yeon
- Zetterberg, Henrik
- Blennow, Kaj
- Ashton, Nicholas J.
- Braunstein, Joel B.
- Verghese, Philip B.
- West, Tim
- Meyer, Matthew R.
- Seo, Sang Won
- Jang, Hyemin
- Lee, Eek-Sung
- Chin, Juhee
- Kim, Hang-Rai
- Na, Seunghee
- Kim, Geon Ha
- Cho, Hanna
- Kim, Byeong C.
- Byun, Min Soo
- Yi, Dahyun
- Jang, Jae-Won
- Jeong, Jee Hyang
- Jung, Young Hee
- Kim, Jong Hun
- Cheon, Bo Kyoung
- Noh, Young
- Shin, Hae-Eun
- Shin, Ki Young
- Park, Yu Hyun
- Lee, Na Kyung
- Cho, Minyoung
- Venue
- JAMA Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2026-03-01
- Volume
- 83
- Issue
- 3
- Pages
- 269
- ISSN
- 2168-6149 (ISSN-L)
- PMC
- PMC12865699
- OpenAlex
- W7127189063
- Cited by
- 13
- References
- 33
- Citations by year
- 2026: 13
- FWCI
- 61.91
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- JAMA Neurology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Alzheimer's Association (SG-23-1038904 QC, ZEN-21-848495, SG-23-1038904, 2021 Zenith Award)
- University of Wisconsin-Madison
- Demensförbundet
- National Institute for Health and Care Research
- King's College London
- University College London
- European Commission (860197)
- National Research Foundation
- Chonnam National University
- Kangwon National University
- Pusan National University
- University of Ulsan
- Hallym University
- Inje University
- Sungkyunkwan University
- Korea Health Industry Development Institute (RS-2022-KH125667)
- National Research Foundation of Korea (RS‐2019‐NR040057)
- Vetenskapsrådet (2017-00915)
- Sahlgrenska Universitetssjukhuset
- Göteborgs Universitet
- University of Science and Technology of China
- Ministry of SMEs and Startups
- Ministry of Science and ICT, South Korea (2021-II212068, RS-2019-NR040057, RS-2022-KH125667, RS-2020-KH107436, RS-2021-II212068)
- Jeonbuk National University
- UK Dementia Research Institute
- Sorbonne Université
- Fondation pour la Recherche sur Alzheimer
- Samsung
- School of Medicine and Public Health, University of Wisconsin-Madison
- Institute of Psychiatry, Psychology and Neuroscience, King’s College London
- Korea National Institute of Health
- Sahlgrenska Akademin
- Institute for Information and Communications Technology Promotion (2022-, RS‐2021‐II212068)
- School of Life Sciences and Biotechnology Division of Life Sciences, Korea University
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- phosphorylated tau217, plasma biomarkers, Alzheimer's disease, amyloid PET, cut-off values, chronic kidney disease, estimated glomerular filtration rate, body mass index, obesity, underweight, anemia, hemoglobin, cost-effectiveness, diagnostic accuracy
- MeSH terms
- Aged, Aged, 80 and over, Alzheimer Disease, Anemia, Cross-Sectional Studies, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Phosphorylation, Cohort Studies, Biomarkers, Body Mass Index, Amyloid beta-Peptides, tau Proteins, Positron-Emission Tomography, Renal Insufficiency, Chronic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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