Anna Mammel, Ging-Yuek Robin, Ali Mousavi, Kelsey Hallett, Ian R MacKenzie, Veronica Hirsch-Reinshagen, Donald Biehl, Pradip Gill, Mary Encarnacion, Hans Frykman
{"title":"神经病理学确诊样本中两种血浆 p-tau217 实验室开发检验的阿尔茨海默病临床决策点","authors":"Anna Mammel, Ging-Yuek Robin, Ali Mousavi, Kelsey Hallett, Ian R MacKenzie, Veronica Hirsch-Reinshagen, Donald Biehl, Pradip Gill, Mary Encarnacion, Hans Frykman","doi":"10.1101/2024.07.27.24310872","DOIUrl":null,"url":null,"abstract":"INTRODUCTION: We evaluated the diagnostic performance of two commercial plasma p-tau217 immunoassays compared to CSF testing and neuropathology. METHODS: 170 plasma samples from 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 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. 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.","PeriodicalId":506788,"journal":{"name":"medRxiv","volume":"7 8","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Alzheimer's Disease clinical decision points for two plasma p-tau217 laboratory developed tests in neuropathology confirmed samples\",\"authors\":\"Anna Mammel, Ging-Yuek Robin, Ali Mousavi, Kelsey Hallett, Ian R MacKenzie, Veronica Hirsch-Reinshagen, Donald Biehl, Pradip Gill, Mary Encarnacion, Hans Frykman\",\"doi\":\"10.1101/2024.07.27.24310872\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"INTRODUCTION: We evaluated the diagnostic performance of two commercial plasma p-tau217 immunoassays compared to CSF testing and neuropathology. METHODS: 170 plasma samples from 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 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. 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.\",\"PeriodicalId\":506788,\"journal\":{\"name\":\"medRxiv\",\"volume\":\"7 8\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"medRxiv\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1101/2024.07.27.24310872\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"medRxiv","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2024.07.27.24310872","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Alzheimer's Disease clinical decision points for two plasma p-tau217 laboratory developed tests in neuropathology confirmed samples
INTRODUCTION: We evaluated the diagnostic performance of two commercial plasma p-tau217 immunoassays compared to CSF testing and neuropathology. METHODS: 170 plasma samples from 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 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. 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.