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Peer-reviewedCC BY-NC-NDJournal of neurology

Clinical performance and decision thresholds of an automated plasma p-tau217 assay for amyloid pathology in a Taiwanese memory clinic.

  • Yung-Shuan Lin1,2,3
  • Meng-Ju Tsai1,2,4
  • Chien-Liang Lai5
  • Hsiang-Ling Ho6,7
  • Jong-Ling Fuh8,9,10
10 affiliations
  1. 1Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, 112201, Taiwan.
  2. 2School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, 112304, Taiwan.
  3. 3Institute of Brain Science, National Yang Ming Chiao Tung University, Taipei, 112304, Taiwan.
  4. 4Graduate Institute of Medical Sciences, National Defense Medical University, Taipei, 114202, Taiwan.
  5. 5Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou Dist., Taipei, 112201, Taiwan.
  6. 6Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou Dist., Taipei, 112201, Taiwan. [email protected].
  7. 7Department of Biotechnology and Laboratory Science in Medicine, National Yang Ming Chiao Tung University, Taipei, 112304, Taiwan. [email protected].
  8. 8Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, 112201, Taiwan. [email protected].
  9. 9School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, 112304, Taiwan. [email protected].
  10. 10Brain Research Center, National Yang Ming Chiao Tung University, Taipei, 112304, Taiwan. [email protected].
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Abstract

Background

Fully automated plasma p-tau217 assays may facilitate clinical implementation of blood-based testing for Alzheimer's disease (AD) amyloid pathology. However, data on assay-specific decision thresholds and clinical utility in East Asian memory-clinic populations remain limited.Methods

We evaluated plasma Roche p-tau217 in 139 participants from a Taiwanese memory clinic using amyloid PET or CSF biomarkers as reference standards. Diagnostic performance and single- and dual-cutoff decision thresholds were assessed. Head-to-head comparisons with Simoa p-tau217, Roche p-tau181, and neurofilament light chain (NfL) were performed in participants with complete biomarker profiles. Associations with body mass index and renal function were also examined.Results

Roche p-tau217 showed high diagnostic accuracy for amyloid β (Aβ) positivity (AUC 0.973). In the primary threshold-analysis cohort, a dual-cutoff approach using thresholds of 0.225 and 0.336 pg/mL classified 88.1% of participants into definitive negative or positive zones, with an overall percent agreement of 95.0% within these zones. Sensitivity analyses showed similar performance. In participants with complete biomarker profiles, no statistically significant difference in AUC was detected between Roche p-tau217 and Simoa p-tau217, whereas Roche p-tau217 showed significantly higher AUC than p-tau181 and NfL. Lower estimated glomerular filtration rate (eGFR) was independently associated with higher p-tau217 concentrations.Conclusions

Fully automated Roche p-tau217 showed high diagnostic performance for identifying Aβ pathology. Cohort-derived dual decision thresholds classified most participants into definitive zones and may support plasma p-tau217-based triage for confirmatory amyloid testing in memory-clinic practice. External validation is required before clinical implementation.

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Cite

BibTeXRIS
BibTeX
@article{lin2026clinical,
  title = {{Clinical performance and decision thresholds of an automated plasma p-tau217 assay for amyloid pathology in a Taiwanese memory clinic.}},
  author = {Yung-Shuan Lin and Meng-Ju Tsai and Chien-Liang Lai and Hsiang-Ling Ho and Jong-Ling Fuh},
  journal = {Journal of neurology},
  year = {2026},
  month = oct,
  doi = {10.1007/s00415-026-14193-2},
  url = {https://europepmc.org/article/MED/42905283},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Clinical performance and decision thresholds of an automated plasma p-tau217 assay for amyloid pathology in a Taiwanese memory clinic.
AU  - Yung-Shuan Lin
AU  - Meng-Ju Tsai
AU  - Chien-Liang Lai
AU  - Hsiang-Ling Ho
AU  - Jong-Ling Fuh
PY  - 2026
DA  - 2026/10/21
JO  - Journal of neurology
DO  - 10.1007/s00415-026-14193-2
UR  - https://europepmc.org/article/MED/42905283
AB  - Background  Fully automated plasma p-tau217 assays may facilitate clinical implementation of blood-based testing for Alzheimer's disease (AD) amyloid pathology. However, data on assay-specific decision thresholds and clinical utility in East Asian memory-clinic populations remain limited.Methods  We evaluated plasma Roche p-tau217 in 139 participants from a Taiwanese memory clinic using amyloid PET or CSF biomarkers as reference standards. Diagnostic performance and single- and dual-cutoff decision thresholds were assessed. Head-to-head comparisons with Simoa p-tau217, Roche p-tau181, and neurofilament light chain (NfL) were performed in participants with complete biomarker profiles. Associations with body mass index and renal function were also examined.Results  Roche p-tau217 showed high diagnostic accuracy for amyloid β (Aβ) positivity (AUC 0.973). In the primary threshold-analysis cohort, a dual-cutoff approach using thresholds of 0.225 and 0.336 pg/mL classified 88.1% of participants into definitive negative or positive zones, with an overall percent agreement of 95.0% within these zones. Sensitivity analyses showed similar performance. In participants with complete biomarker profiles, no statistically significant difference in AUC was detected between Roche p-tau217 and Simoa p-tau217, whereas Roche p-tau217 showed significantly higher AUC than p-tau181 and NfL. Lower estimated glomerular filtration rate (eGFR) was independently associated with higher p-tau217 concentrations.Conclusions  Fully automated Roche p-tau217 showed high diagnostic performance for identifying Aβ pathology. Cohort-derived dual decision thresholds classified most participants into definitive zones and may support plasma p-tau217-based triage for confirmatory amyloid testing in memory-clinic practice. External validation is required before clinical implementation.
SN  - 0340-5354
SN  - 1432-1459
ER  -