{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T16:17:51Z","timestamp":1790612271503,"version":"4.1.0"},"reference-count":46,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"vor","delay-in-days":51,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["#10510032120003"],"award-info":[{"award-number":["#10510032120003"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002565","name":"Alzheimer's Drug Discovery Foundation","doi-asserted-by":"publisher","award":["202009\u20102020783"],"award-info":[{"award-number":["202009\u20102020783"]}],"id":[{"id":"10.13039\/100002565","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["alz-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Alz &amp;amp; Dem Diag Ass &amp;amp; Dis Mo"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>INTRODUCTION<\/jats:title>\n                    <jats:p>To address an urgent need for a scalable, accurate blood test for brain amyloid pathology that provides a conclusive result for the greatest number of patients, we developed a multi\u2010analyte algorithmic test combining phosphorylated tau (p\u2010tau) 217 with four other biomarkers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Multiplexed digital immunoassays measured p\u2010tau 217, amyloid beta 42\/40, glial fibrillary acidic protein, and neurofilament light chain in 730 symptomatic individuals (training set) to establish an algorithm with cutoffs, and 1082 symptomatic individuals (validation set) from three independent cohorts to identify brain amyloid pathology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The algorithmic in validation gave an area under the curve\u00a0=\u00a00.92, yielding 90% agreement with amyloid positron emission tomography and cerebrospinal fluid. Positive predictive value was 92% at 55% prevalence. The multi\u2010marker algorithm reduced the intermediate zone \u2248 3\u2010fold from 34.4% to 11.9% versus p\u2010tau 217 alone. Diagnostic performance was similar across subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DISCUSSION<\/jats:title>\n                    <jats:p>The LucentAD Complete multi\u2010analyte blood test demonstrated high clinical validity for brain amyloid pathology detection while substantially reducing inconclusive intermediate results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Highlights<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>We developed a multi\u2010analyte blood test for assessing brain amyloid status that significantly minimizes the ambiguous \u201cintermediate zone,\u201d a key limitation of plasma phosphorylated tau (p\u2010tau) 217 alone.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>Our test combines plasma levels of p\u2010tau 217, amyloid beta 42\/40 ratio, glial fibrillary acidic protein, and neurofilament light chain for a more comprehensive evaluation of amyloid status.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>We rigorously validated the test's clinical performance in &gt; 1000 samples from symptomatic individuals across three independent cohorts, using cerebrospinal fluid biomarkers and amyloid positron emission tomography as comparators.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/dad2.70215","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T11:28:03Z","timestamp":1763724483000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical performance of scalable automated p\u2010tau 217 multi\u2010analyte algorithmic blood test with reduced intermediate zone using multiplexed digital immunoassay"],"prefix":"10.1002","volume":"17","author":[{"given":"David H.","family":"Wilson","sequence":"first","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Copeland","sequence":"additional","affiliation":[{"name":"Boulder Statistics  Steamboat Springs Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Miller","sequence":"additional","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann\u2010Jeanette","family":"Vasko","sequence":"additional","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyndal","family":"Hesterberg","sequence":"additional","affiliation":[{"name":"HCS, Inc.  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meenakshi","family":"Khare","sequence":"additional","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Wolfe","sequence":"additional","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Sheehy","sequence":"additional","affiliation":[{"name":"Quanterix Corporation  Billerica Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge","family":"Verberk","sequence":"additional","affiliation":[{"name":"Neurochemistry Laboratory, Department of Laboratory Medicine Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Neuroscience  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Teunissen","sequence":"additional","affiliation":[{"name":"Neurochemistry Laboratory, Department of Laboratory Medicine Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Neuroscience  Amsterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,21]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13859"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2024.3770"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s43587\u2010023\u201000471\u20105"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582\u2010024\u201000977\u20105"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2019.03.009"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/cells12091309"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415\u2010022\u201011055\u20105"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12724"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2023.5319"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14536"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010024\u201001513\u20109"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195\u2010022\u201000990\u20100"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-132306"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-170850"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.34.7.939"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.56.3.303"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/dad2.12182"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14088"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.13722"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2018.02.018"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181cb3e25"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.14315"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/2211068215589580"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.1641"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2025.1568971"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.4669"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-018-0350-6"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1590\/S1980-57642013DN70100005"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.2165\/11533100-000000000-00000"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.58.11.1615"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0072-9752(07)01232-8"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/dad2.12471"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(20)32205\u20104"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474\u20104422(21)00361\u20106"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tjpad.2024.100044"},{"key":"e_1_2_8_37_1","unstructured":"PalmqvistS WarmenhovenN AnastasiF et\u00a0al.Session 2\u201030\u2010FRS\u2010B\u2014Real\u2010world clinical performance of blood biomarkers for the diagnosis of Alzheimer's Disease.Clinical performance of blood biomarkers across settings and countries [Oral presentation]. 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