Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples
Abstract INTRODUCTION We evaluated the diagnostic performance of two commercial plasma p‐tau217 immunoassays compared to cerebrospinal fluid (CSF) testing and neuropathology. METHODS One hundred and seventy plasma samples from the University of British Columbia Hospital Clinic for Alzheimer's (...
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| Format: | Article |
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Wiley
2025-01-01
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| Series: | Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring |
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| Online Access: | https://doi.org/10.1002/dad2.70070 |
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| author | Anna E. Mammel Ging‐Yuek Robin Hsiung Ali Mousavi Kelsey Hallett Ian R. Mackenzie Veronica Hirsch‐Reinshagen Don Biehl Pradip Gill Mary Encarnacion Hans Frykman |
| author_facet | Anna E. Mammel Ging‐Yuek Robin Hsiung Ali Mousavi Kelsey Hallett Ian R. Mackenzie Veronica Hirsch‐Reinshagen Don Biehl Pradip Gill Mary Encarnacion Hans Frykman |
| author_sort | Anna E. Mammel |
| collection | DOAJ |
| description | Abstract INTRODUCTION We evaluated the diagnostic performance of two commercial plasma p‐tau217 immunoassays compared to cerebrospinal fluid (CSF) testing and neuropathology. METHODS One hundred and seventy plasma samples from the University of British Columbia Hospital Clinic for Alzheimer's (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. RESULTS Fujirebio and ALZpath p‐tau217 had similar overall analytical and clinical performance, with distinct decision points for each assay. Based on autopsy findings, both p‐tau217 assays identified individuals with AD from other neurodegenerative diseases (ALZpath area under the curve [AUC] = 0.94, Fujirebio AUC = 0.90). The ALZpath assay detected AD pathology at milder disease stages compared to the Fujirebio assay. DISCUSSION Our 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. Highlights Two commercially available p‐tau217 immunoassays (ALZpath and Fujirebio) showed equal performance based on CSF testing. ALZpath p‐tau217 showed higher performance compared to Fujirebio p‐tau217 based on AD diagnosis by neuropathology confirmation. Specific plasma p‐tau217 assays may require distinct decision points for AD screening, diagnosis, and disease progression monitoring. |
| format | Article |
| id | doaj-art-53ce4bc147be4e70ab0ee6ef851e1b70 |
| institution | DOAJ |
| issn | 2352-8729 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring |
| spelling | doaj-art-53ce4bc147be4e70ab0ee6ef851e1b702025-08-20T02:49:22ZengWileyAlzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring2352-87292025-01-01171n/an/a10.1002/dad2.70070Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samplesAnna E. Mammel0Ging‐Yuek Robin Hsiung1Ali Mousavi2Kelsey Hallett3Ian R. Mackenzie4Veronica Hirsch‐Reinshagen5Don Biehl6Pradip Gill7Mary Encarnacion8Hans Frykman9Neurochemistry Neurocode USA Inc Bellingham USADivision of Neurology Department of Medicine University of British Columbia Vancouver CanadaDivision of Neurology Department of Medicine University of British Columbia Vancouver CanadaNeurochemistry Neurocode USA Inc Bellingham USADepartment of Pathology and Laboratory Medicine University of British Columbia Vancouver CanadaDepartment of Pathology and Laboratory Medicine University of British Columbia Vancouver CanadaNeurochemistry Neurocode USA Inc Bellingham USANeurochemistry Neurocode USA Inc Bellingham USANeurochemistry BC Neuroimmunology Laboratory Vancouver CanadaNeurochemistry Neurocode USA Inc Bellingham USAAbstract INTRODUCTION We evaluated the diagnostic performance of two commercial plasma p‐tau217 immunoassays compared to cerebrospinal fluid (CSF) testing and neuropathology. METHODS One hundred and seventy plasma samples from the University of British Columbia Hospital Clinic for Alzheimer's (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. RESULTS Fujirebio and ALZpath p‐tau217 had similar overall analytical and clinical performance, with distinct decision points for each assay. Based on autopsy findings, both p‐tau217 assays identified individuals with AD from other neurodegenerative diseases (ALZpath area under the curve [AUC] = 0.94, Fujirebio AUC = 0.90). The ALZpath assay detected AD pathology at milder disease stages compared to the Fujirebio assay. DISCUSSION Our 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. Highlights Two commercially available p‐tau217 immunoassays (ALZpath and Fujirebio) showed equal performance based on CSF testing. ALZpath p‐tau217 showed higher performance compared to Fujirebio p‐tau217 based on AD diagnosis by neuropathology confirmation. Specific plasma p‐tau217 assays may require distinct decision points for AD screening, diagnosis, and disease progression monitoring.https://doi.org/10.1002/dad2.70070Alzheimer's diseaseCSF Aβ 42 to 40 ratioCSF p‐tau181immunoassaysneuropathology diagnosisplasma p‐tau217 |
| spellingShingle | Anna E. Mammel Ging‐Yuek Robin Hsiung Ali Mousavi Kelsey Hallett Ian R. Mackenzie Veronica Hirsch‐Reinshagen Don Biehl Pradip Gill Mary Encarnacion Hans Frykman Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring Alzheimer's disease CSF Aβ 42 to 40 ratio CSF p‐tau181 immunoassays neuropathology diagnosis plasma p‐tau217 |
| title | Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples |
| title_full | Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples |
| title_fullStr | Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples |
| title_full_unstemmed | Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples |
| title_short | Clinical decision points for two plasma p‐tau217 laboratory developed tests in neuropathology confirmed samples |
| title_sort | clinical decision points for two plasma p tau217 laboratory developed tests in neuropathology confirmed samples |
| topic | Alzheimer's disease CSF Aβ 42 to 40 ratio CSF p‐tau181 immunoassays neuropathology diagnosis plasma p‐tau217 |
| url | https://doi.org/10.1002/dad2.70070 |
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