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Peer-reviewedCC BY-NC-ND 4.0Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring

Multi‐platform comparison of plasma phosphorylated tau assays: analytical and workflow factors drive clinical implementation decisions

  • Olga Sandoval‐Boczkowska1
  • John R. Best2
  • Rachael J. Y. Smith3
  • Laura Burns4
  • Cyril Helbling1
  • Ging‐Yuek Robin Hsiung3
  • Jacqueline A. Pettersen3
  • Philip E. Lee3
  • Alexandre Henri‐Bhargava3
  • Haakon B. Nygaard3
  • Mari L. DeMarco1,4
4 affiliations
  1. 1Department of Pathology and Laboratory Medicine University of British Columbia Vancouver Canada
  2. 2Department of Psychiatry University of British Columbia Vancouver Canada
  3. 3Division of Neurology Department of Medicine University of British Columbia Vancouver Canada
  4. 4Department of Pathology and Laboratory Medicine St. Paul's Hospital Providence Health Care Vancouver Canada
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Abstract

INTRODUCTION: Multiple plasma phosphorylated tau assays are now commercially available for Alzheimer's disease (AD), yet clinical laboratories lack comprehensive comparative data to guide implementation.

METHODS: We assessed diagnostic accuracy and analytical performance in 273 participants with paired plasma and cerebrospinal fluid (CSF). CSF AD core biomarkers served as the reference standard. Index tests included three plasma tau phosphorylated at residue 217 (pTau217) assays (Roche, Fujirebio, Meso Scale Discovery [MSD]) and a pTau181 assay (Roche).

RESULTS: Participants: median age 70 [IQR: 64 to 76] years, 42% female, and 60% AD‐positive. pTau217 assays showed comparable accuracy (area under the curve [AUC] 0.88 to 0.89) exceeding pTau181 (AUC 0.85). All assays were resistant to hemolysis, icterus, and lipemia. Automated assays (Roche, Fujirebio) showed superior analytical precision and freeze/thaw stability (≥6 cycles) compared to the manual MSD assay (two cycles).

DISCUSSION: With comparable diagnostic accuracy across pTau217 platforms, analytical performance, and operational suitability became decisive implementation differentiators.

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Cite

BibTeXRIS
BibTeX
@article{sandovalboczkowska2026multiplatform,
  title = {{Multi‐platform comparison of plasma phosphorylated tau assays: analytical and workflow factors drive clinical implementation decisions}},
  author = {Olga Sandoval‐Boczkowska and John R. Best and Rachael J. Y. Smith and Laura Burns and Cyril Helbling and Ging‐Yuek Robin Hsiung and Jacqueline A. Pettersen and Philip E. Lee and Alexandre Henri‐Bhargava and Haakon B. Nygaard and Mari L. DeMarco},
  journal = {Alzheimer's \& Dementia : Diagnosis, Assessment \& Disease Monitoring},
  year = {2026},
  month = nov,
  doi = {10.1002/dad2.70465},
  url = {https://doi.org/10.1002/dad2.70465},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Multi‐platform comparison of plasma phosphorylated tau assays: analytical and workflow factors drive clinical implementation decisions
AU  - Olga Sandoval‐Boczkowska
AU  - John R. Best
AU  - Rachael J. Y. Smith
AU  - Laura Burns
AU  - Cyril Helbling
AU  - Ging‐Yuek Robin Hsiung
AU  - Jacqueline A. Pettersen
AU  - Philip E. Lee
AU  - Alexandre Henri‐Bhargava
AU  - Haakon B. Nygaard
AU  - Mari L. DeMarco
PY  - 2026
DA  - 2026/11/02
JO  - Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring
DO  - 10.1002/dad2.70465
UR  - https://doi.org/10.1002/dad2.70465
AB  - INTRODUCTION: Multiple plasma phosphorylated tau assays are now commercially available for Alzheimer's disease (AD), yet clinical laboratories lack comprehensive comparative data to guide implementation.  METHODS: We assessed diagnostic accuracy and analytical performance in 273 participants with paired plasma and cerebrospinal fluid (CSF). CSF AD core biomarkers served as the reference standard. Index tests included three plasma tau phosphorylated at residue 217 (pTau217) assays (Roche, Fujirebio, Meso Scale Discovery [MSD]) and a pTau181 assay (Roche).  RESULTS: Participants: median age 70 [IQR: 64 to 76] years, 42% female, and 60% AD‐positive. pTau217 assays showed comparable accuracy (area under the curve [AUC] 0.88 to 0.89) exceeding pTau181 (AUC 0.85). All assays were resistant to hemolysis, icterus, and lipemia. Automated assays (Roche, Fujirebio) showed superior analytical precision and freeze/thaw stability (≥6 cycles) compared to the manual MSD assay (two cycles).  DISCUSSION: With comparable diagnostic accuracy across pTau217 platforms, analytical performance, and operational suitability became decisive implementation differentiators.
SN  - 2352-8729
ER  -