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Plasma p-Tau217 improves diagnostic accuracy and clinician confidence in cognitive disorder classification
Yu-Yuan Huang1, Ling-Ling Li1, Rui-Xin Yao1
1Department of Neurology and National Center for Neurological Disorders, Huashan Hospital, State Key Laboratory of Brain Function and Disorders, MOE Frontiers Center for Brain Science, Shanghai Academy of Natural Sciences, New Cornerstone Science Laboratory, Shanghai Medical College, Fudan University, Shanghai 200040, China.
Abstract:
The clinical utility of plasma phosphorylated tau at threonine 217 (p-tau217) levels as a diagnostic tool for cognitive disorders in real-world settings remains uncertain. In this cross-sectional retrospective study, 738 consecutive subjects presenting with cognitive complaints at a memory clinic underwent diagnostic evaluation incorporating plasma p-tau217 alongside standard clinical assessments ("tier 2": routine neuroimaging and cognitive testing) and advanced biomarker testing ("tier 1": amyloid positron emission tomography [PET] imaging or cerebrospinal fluid [CSF] analysis). Diagnostic impact and confidence were assessed using clinician surveys. Incorporating plasma p-tau217 into the routine tier 2 diagnostic workup significantly influenced clinical decision-making, leading to diagnostic revisions in 30.2% of cases and improving overall diagnostic confidence from 65.1% to 79.4%. Plasma p-tau217 demonstrated high diagnostic accuracy for Alzheimer's disease (AD), with a sensitivity of 0.88 and a specificity of 0.84. Notably, its specificity was superior to tier 2 diagnoses, whereas its sensitivity did not differ significantly. Plasma p-tau217 also exhibited non-inferior performance to tier 1 approaches in the diagnostic distribution of AD, though with marginally lower diagnostic confidence. For non-AD diagnoses, plasma p-tau217 significantly impacted the classification of synucleinopathies and performed comparably to tier 1 methods. In conclusion, plasma p-tau217 meaningfully impacted diagnostic precision and confidence in subjects presenting to a real-world memory clinic, offering a minimally invasive, cost-effective, and accessible alternative to state-of-the-art examinations. As the global population ages and cognitive disorders become more prevalent, the integration of plasma p-tau217 into routine practice has the potential to streamline diagnostic workflows and enhance the efficient utilization of medical resources.
