- pTau217 assays showed comparable diagnostic accuracy, AUC 0.88 to 0.89, outperforming pTau181 (AUC 0.85).
- Automated assays (Roche, Fujirebio) had superior analytical precision and freeze/thaw stability of at least six cycles versus manual MSD (two cycles).
- Although all assays resisted haemolysis, icterus, and lipemia, analytical performance and operational suitability drive clinical implementation decisions.
Alzheimers Dement (Amst). 2026 Nov 2;18(4):e70465. doi: 10.1002/dad2.70465. eCollection 2026 Oct-Dec.
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.
PMID:42979019 | PMC:PMC13728325 | DOI:10.1002/dad2.70465
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