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Hoffmann-La Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's & Dementia"],"published-print":{"date-parts":[[2026,1]]},"abstract":"Abstract<\/jats:title>\n \n INTRODUCTION<\/jats:title>\n \n We evaluated the clinical performance of the fully automated, high\u2010throughput, prototype Elecsys\n \u00ae<\/jats:sup>\n Phospho\u2010Tau (217P) plasma immunoassay (Roche Diagnostics) for detecting amyloid pathology.\n <\/jats:p>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n \n Plasma tau phosphorylated at threonine 217 (pTau217) levels were determined in samples from cognitively impaired and unimpaired individuals from five cohorts (\n N\u00a0<\/jats:italic>\n =\u00a02148) using the pTau217 plasma immunoassay. Clinical performance was evaluated against amyloid positron emission tomography.\n <\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n \n For cognitively impaired, mean plasma pTau217 levels for amyloid\u2010positive (A+) individuals were higher (\n n\u00a0<\/jats:italic>\n =\u00a0394; 0.835 pg\/mL) than amyloid\u2010negative (A\u2013) individuals (\n n\u00a0<\/jats:italic>\n =\u00a0144; 0.361 pg\/mL); similarly, for cognitively unimpaired, A+ (\n n\u00a0<\/jats:italic>\n =\u00a0224; 0.516 pg\/mL) and A\u2013 individuals (\n n\u00a0<\/jats:italic>\n =\u00a01386; 0.220 pg\/mL). Area under the curve was 0.878 (95% confidence interval [CI] 0.840, 0.915; impaired) and 0.907 (95% CI 0.885, 0.929; unimpaired). A cutoff\u00a0<\u00a00.189 pg\/mL reliably ruled out individuals without amyloid pathology. High negative predictive values (92.51% [impaired]; 98.60% [unimpaired]) were observed with sensitivity\/specificity of 98.98%\/29.17% and 95.54%\/50.72%, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n DISCUSSION<\/jats:title>\n The pTau217 plasma immunoassay accurately detects amyloid pathology, irrespective of cognitive status.<\/jats:p>\n <\/jats:sec>\n \n TRIAL REGISTRATION NUMBER<\/jats:title>\n A4, NCT02008357; SKYLINE, NCT05256134; AIBL, SAGE Project ID Number: 2022\/PID06188; SVHM Local Ref ID: HREC 028\/06; CREAD, NCT02670083; CREAD2, NCT03114657<\/jats:p>\n <\/jats:sec>\n \n Highlights<\/jats:title>\n \n \n \n \n The Elecsys\n \u00ae<\/jats:sup>\n pTau217 plasma immunoassay (Roche Diagnostics) was evaluated across five cohorts.\n <\/jats:p>\n <\/jats:list-item>\n \n The pTau217 plasma immunoassay demonstrated high performance in detecting amyloid pathology in both cognitively impaired and unimpaired individuals.<\/jats:p>\n <\/jats:list-item>\n \n The pTau217 plasma immunoassay had a high negative predictive value which supports its utility as a pre\u2010screening tool for Alzheimer's disease (AD).<\/jats:p>\n <\/jats:list-item>\n \n The pTau217 plasma immunoassay cutoffs identified are suitable for use as rule\u2010out pre\u2010screener tools in clinical trials.<\/jats:p>\n <\/jats:list-item>\n \n These findings reinforce the value of the high\u2010throughput pTau217 plasma immunoassay measurements to aid AD diagnosis.<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/alz.71009","type":"journal-article","created":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T10:27:34Z","timestamp":1768472854000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts"],"prefix":"10.1002","volume":"22","author":[{"given":"Derrek P.","family":"Hibar","sequence":"first","affiliation":[{"name":"Genentech, Inc. South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Bauer","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Rabe","sequence":"additional","affiliation":[{"name":"Genentech, Inc. South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Borlinghaus","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Jethwa","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwendlyn","family":"Kollmorgen","sequence":"additional","affiliation":[{"name":"Roche Diagnostics GmbH Penzberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annunziata","family":"Di Domenico","sequence":"additional","affiliation":[{"name":"Roche Diagnostics International Ltd Rotkreuz Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Zetterberg","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology The Sahlgrenska Academy at the University of Gothenburg M\u00f6lndal Sweden"},{"name":"Clinical Neurochemistry Laboratory Sahlgrenska University Hospital M\u00f6lndal Sweden"},{"name":"Department of Neurodegenerative Disease UCL Institute of Neurology London UK"},{"name":"UK Dementia Research Institute at UCL London UK"},{"name":"Hong Kong Center for Neurodegenerative Diseases InnoHK Hong Kong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaj","family":"Blennow","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology The Sahlgrenska Academy at the University of Gothenburg M\u00f6lndal Sweden"},{"name":"Clinical Neurochemistry Laboratory Sahlgrenska University Hospital M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin L.","family":"Masters","sequence":"additional","affiliation":[{"name":"Florey Institute of Neuroscience and Mental Health University of Melbourne Parkville Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reisa A.","family":"Sperling","sequence":"additional","affiliation":[{"name":"Center for Alzheimer Research and Treatment, Brigham and Women's Hospital Massachusetts General Hospital, Harvard Medical School Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9256-0360","authenticated-orcid":false,"given":"Tobias","family":"Bittner","sequence":"additional","affiliation":[{"name":"Genentech, Inc. 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