Alzheimer's Disease clinical decision points for two plasma p-tau217 laboratory developed tests in neuropathology confirmed samples
Mammel, A. E.; Hsiung, G.-Y. R.; Mousavi, A.; Hallett, K.; Mackenzie, I. R.; Hirsch-Reinshagen, V.; Biehl, D.; Gill, P.; Encarnacion, M.; Frykman, H.
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INTRODUCTIONWe evaluated the diagnostic performance of two commercial plasma p-tau217 immunoassays compared to CSF testing and neuropathology. METHODS170 plasma samples from University of British Columbia Hospital Clinic for Alzheimers (AD) and Related Disorders were analyzed for p-tau217 using Fujirebio and ALZpath assays. Decision points were determined using CSF testing and autopsy findings as the standard. RESULTSFujirebio and ALZpath p-tau217 had similar overall analytical and clinical performance, with distinct decision points for each assay. Based on autopsy finding, both p-tau217 assays identified individuals with AD from other neurodegenerative diseases (ALZpath AUC = 0.94, Fujirebio AUC= 0.90). The ALZpath assay detected AD pathology at milder disease stages compared to the Fujirebio assay. DISCUSSIONOur study reinforces the clinical utility of plasma p-tau217 as an AD biomarker. Differences in test performance and clinical decision points suggest an assay specific diagnostic approach is required for plasma p-tau217 in clinical practice.
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