{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T23:12:40Z","timestamp":1791673960701,"version":"4.3.4"},"reference-count":44,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T00:00:00Z","timestamp":1776124800000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100005760","name":"G\u00f6teborgs Universitet","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005760","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004359","name":"Vetenskapsr\u00e5det","doi-asserted-by":"publisher","award":["2023\u201300356"],"award-info":[{"award-number":["2023\u201300356"]}],"id":[{"id":"10.13039\/501100004359","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004359","name":"Vetenskapsr\u00e5det","doi-asserted-by":"publisher","award":["2022\u201301018"],"award-info":[{"award-number":["2022\u201301018"]}],"id":[{"id":"10.13039\/501100004359","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004359","name":"Vetenskapsr\u00e5det","doi-asserted-by":"publisher","award":["2019\u201002397"],"award-info":[{"award-number":["2019\u201002397"]}],"id":[{"id":"10.13039\/501100004359","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000957","name":"Alzheimer's Association","doi-asserted-by":"publisher","award":["ADSF\u201021\u2013831376\u2010C"],"award-info":[{"award-number":["ADSF\u201021\u2013831376\u2010C"]}],"id":[{"id":"10.13039\/100000957","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000957","name":"Alzheimer's Association","doi-asserted-by":"publisher","award":["ADSF\u201021\u2013831381\u2010C"],"award-info":[{"award-number":["ADSF\u201021\u2013831381\u2010C"]}],"id":[{"id":"10.13039\/100000957","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000957","name":"Alzheimer's Association","doi-asserted-by":"publisher","award":["ADSF\u201021\u2013831377\u2010C"],"award-info":[{"award-number":["ADSF\u201021\u2013831377\u2010C"]}],"id":[{"id":"10.13039\/100000957","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000957","name":"Alzheimer's Association","doi-asserted-by":"publisher","award":["ADSF\u201024\u20131284328\u2010C"],"award-info":[{"award-number":["ADSF\u201024\u20131284328\u2010C"]}],"id":[{"id":"10.13039\/100000957","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007625","name":"Cure Alzheimer's Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007625","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007436","name":"Erling-Perssons Stiftelse","doi-asserted-by":"publisher","award":["FO2022\u20100270"],"award-info":[{"award-number":["FO2022\u20100270"]}],"id":[{"id":"10.13039\/100007436","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100017510","name":"UK Dementia Research Institute","doi-asserted-by":"publisher","award":["UKDRI\u20101003"],"award-info":[{"award-number":["UKDRI\u20101003"]}],"id":[{"id":"10.13039\/501100017510","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003792","name":"Hj\u00e4rnfonden","doi-asserted-by":"publisher","award":["FO2024\u20100097"],"award-info":[{"award-number":["FO2024\u20100097"]}],"id":[{"id":"10.13039\/501100003792","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003792","name":"Hj\u00e4rnfonden","doi-asserted-by":"publisher","award":["ALFGBG\u2010984092"],"award-info":[{"award-number":["ALFGBG\u2010984092"]}],"id":[{"id":"10.13039\/501100003792","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003792","name":"Hj\u00e4rnfonden","doi-asserted-by":"publisher","award":["ALFGBG\u2010984092"],"award-info":[{"award-number":["ALFGBG\u2010984092"]}],"id":[{"id":"10.13039\/501100003792","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009408","name":"Fondation Brain Canada","doi-asserted-by":"publisher","award":["34874"],"award-info":[{"award-number":["34874"]}],"id":[{"id":"10.13039\/100009408","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009408","name":"Fondation Brain Canada","doi-asserted-by":"publisher","award":["33397"],"award-info":[{"award-number":["33397"]}],"id":[{"id":"10.13039\/100009408","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alzheimer's &amp;amp; Dementia"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>Although several plasma tau phosphorylated at threonine 217 (p\u2010tau217) immunoassays are now available, comprehensive analytical validation remains limited. We therefore evaluated the Lumipulse G plasma p\u2010tau217 assay and verified established cutoffs for clinical implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>This study was conducted in two phases: (1) analytical validation of the Lumipulse G plasma p\u2010tau217 assay, assessing precision, lower limit of quantification (LLoQ), selectivity, stability, and interference; and (2) verification of previously established cutoffs using a two\u2010threshold approach in 37 samples with confirmed cerebrospinal fluid (CSF) A\u03b242\/A\u03b240 status.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      The assay demonstrated strong analytical performance, with repeatability and intermediate precision (%CV\u00a0&lt;\u00a07%) and an LLoQ of 0.12\u00a0pg\/mL. The p\u2010tau217 was stable across freeze\u2013thaw cycles but less so at 4\u00b0C, and hemolysis\u00a0&gt;\u00a02% introduced variability. Cutoff verification showed 97% reproducibility with excellent agreement (\n                      <jats:italic>\u03c1<\/jats:italic>\n                      \u00a0=\u00a00.99,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.0001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>The Lumipulse assay showed robust analytical performance and reproducibility, supporting clinical use, though certified reference materials are still needed for standardization.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/alz.71374","type":"journal-article","created":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T03:05:56Z","timestamp":1776222356000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Analytical and clinical validation of the Lumipulse G plasma p\u2010tau217 assay for clinical implementation"],"prefix":"10.1002","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7229-3226","authenticated-orcid":false,"given":"Burak","family":"Arslan","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; 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":"Johan","family":"Gobom","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; 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":"Ulf","family":"Andreasson","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; 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":"Laia","family":"Montoliu\u2010Gaya","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea L.","family":"Benedet","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Dittrich","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"},{"name":"Department of Neuropsychiatry Region V\u00e4stra G\u00f6taland, Sahlgrenska University Hospital  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silke","family":"Kern","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"},{"name":"Department of Neuropsychiatry Region V\u00e4stra G\u00f6taland, Sahlgrenska University Hospital  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingmar","family":"Skoog","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"},{"name":"Department of Neuropsychiatry Region V\u00e4stra G\u00f6taland, Sahlgrenska University Hospital  M\u00f6lndal Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas J.","family":"Ashton","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"},{"name":"Banner Sun Health Research Institute  Sun City Arizona USA"},{"name":"Banner Alzheimer's Institute  Phoenix Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tevy","family":"Chan","sequence":"additional","affiliation":[{"name":"Translational Neuroimaging Laboratory, Montreal Neurological Institute\u2010Hospital  Montreal Canada"},{"name":"The Research Institute of the McGill University Health Centre  Montreal Quebec Canada"},{"name":"Division of Geriatric Medicine Department of Medicine McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nesrine","family":"Rahmouni","sequence":"additional","affiliation":[{"name":"Translational Neuroimaging Laboratory, Montreal Neurological Institute\u2010Hospital  Montreal Canada"},{"name":"The Research Institute of the McGill University Health Centre  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Rosa\u2010Neto","sequence":"additional","affiliation":[{"name":"Translational Neuroimaging Laboratory, Montreal Neurological Institute\u2010Hospital  Montreal Canada"},{"name":"Douglas Hospital Research Centre \u2010 Centre int\u00e9gr\u00e9 universitaire de sant\u00e9 et services sociaux de l'Ouest\u2010de\u2010l\u2019\u00cele\u2010de\u2010Montr\u00e9al  Verdun Quebec Canada"},{"name":"Peter O'Donnell Jr. Brain Institute (OBI) University of Texas Southwestern Medical Centre (UTSW)  Dallas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaj","family":"Blennow","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; Physiology, the Sahlgrenska Academy at the University of Gothenburg  M\u00f6lndal Sweden"},{"name":"Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital  M\u00f6lndal Sweden"},{"name":"Paris Brain Institute, ICM, Piti\u00e9\u2010Salp\u00eatri\u00e8re Hospital, Sorbonne University  Paris France"},{"name":"Neurodegenerative Disorder Research Center Division of Life Sciences and Medicine Department of Neurology Institute on Aging and Brain Disorders, University of Science and Technology of China and First Affiliated Hospital of USTC  Hefei P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Zetterberg","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; 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 Pathology and Laboratory Medicine University of Wisconsin School of Medicine and Public Health  Madison Wisconsin USA"},{"name":"Wisconsin Alzheimer's Institute School of Medicine and Public Health, University of Wisconsin  Madison Wisconsin USA"},{"name":"Department of Neurodegenerative Disease Institute of Neurology University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hlin","family":"Kvartsberg","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry Institute of Neuroscience &amp; 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"}]}],"member":"311","published-online":{"date-parts":[[2026,4,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13024\u2010019\u20100333\u20105"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474\u20104422(20)30314\u20108"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awy059"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2014.02.004"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1064"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph14020110"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.2000"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2024.123325"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13455"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587\u2010023\u201000471\u20105"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102023\u20101434"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.5319"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awae368"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010025\u201003622\u2010w"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14140"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14508"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010025\u201001692\u2010z"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awaa286"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2024.2619"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.70038"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.r1082"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00401\u2010023\u201002660\u20103"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13764"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awae346"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvad103"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14609"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102025\u20101192"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587\u2010023\u201000405\u20101"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000011416"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10654\u2010018\u20100459\u20108"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2015.00179"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587\u2010025\u201000951\u2010w"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.70562"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102022\u20100770"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.plabm.2025.e00455"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010024\u201001391\u20101"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1093\/jalm\/jfae155"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.70173"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008081"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2021.3180"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm\u20102021\u20100651"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12801"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010021\u201000942\u20100"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.4719"}],"container-title":["Alzheimer's &amp; Dementia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/alz.71374","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/alz.71374","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/alz.71374","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T07:01:21Z","timestamp":1783321281000},"score":1,"resource":{"primary":{"URL":"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/alz.71374"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":44,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/alz.71374"],"URL":"https:\/\/doi.org\/10.1002\/alz.71374","archive":["Portico"],"relation":{},"ISSN":["1552-5260","1552-5279"],"issn-type":[{"value":"1552-5260","type":"print"},{"value":"1552-5279","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"assertion":[{"value":"2025-09-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e71374"}}