{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T15:33:55Z","timestamp":1789486435063,"version":"build-2803163510"},"reference-count":26,"publisher":"Walter de Gruyter GmbH","issue":"9","license":[{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-0370_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Plasma p-tau217 is a leading blood-based biomarker for Alzheimer\u2019s disease (AD), offering high diagnostic accuracy and potential utility for treatment eligibility and monitoring. However, real-world data on concordance between cerebrospinal fluid (CSF) A\u03b242\/40 and plasma p-tau217 in routine clinical laboratory settings remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0370_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We retrospectively evaluated all plasma p-tau217 tests performed in the Clinical Neurochemistry Laboratory at Sahlgrenska University Hospital between August 2025 and March 2026. De-identified plasma p-tau217, additional blood biomarkers, and available CSF results were extracted from the laboratory information system. Concordance between plasma p-tau217 and CSF A\u03b242\/40 was evaluated by calculating positive and negative percent agreement, with CSF A\u03b242\/40 used as the reference standard. In addition, diagnostic accuracy for brain amyloid positivity was assessed using two predefined clinical cutoffs for plasma p-tau217 (&lt;0.22 vs. &gt;0.34\u202fng\/L). Internal analytical performance was monitored over a six-month period using commercial quality control materials, with additional evaluation of lot-to-lot consistency for plasma p-tau217.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0370_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 1,352 plasma p-tau217 measurements, paired CSF A\u03b242\/40 data were available for 121 individuals. Based on plasma p-tau217 probability categories, 541 samples (40.0\u202f%) were classified as low probability, 228 (16.9\u202f%) as intermediate probability, and 583 (43.1\u202f%) as high probability for amyloid pathology. Using CSF A\u03b242\/40 as the reference standard, plasma p-tau217 demonstrated a positive percent agreement of 84.5\u202f% (95\u202f% CI: 72.6\u201392.7\u202f%) and a negative percent agreement of 87.5\u202f% (95\u202f% CI: 73.2\u201395.8\u202f%). Internal quality control analyses showed good within-batch precision, with coefficients of variation below 7.3\u202f%. Batch-dependent bias was observed in QC measurements, most notably for one batch (+14.4\u201318.4\u202f%); however, subsequent QC investigations indicated that this deviation originated from the QC material rather than from assay-related performance. Lot-to-lot consistency assessment did not reveal systematic reagent lot-dependent effects during the study period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0370_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lumipulse plasma p-tau217 demonstrated stable analytical performance and consistent concordance with CSF A\u03b242\/40 in routine clinical practice. The observed agreement supports the feasibility of plasma p-tau217 as a supportive tool in the clinical evaluation of AD, while underscoring the need for continued quality control monitoring and prospective evaluation of assay performance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-0370","type":"journal-article","created":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T22:26:35Z","timestamp":1777501595000},"page":"1986-1996","source":"Crossref","is-referenced-by-count":1,"title":["Real-world performance of Lumipulse G plasma p-tau217: a six-month experience of a specialized clinical neurochemistry laboratory"],"prefix":"10.1515","volume":"64","author":[{"given":"Burak","family":"Arslan","sequence":"first","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & Physiology, The Sahlgrenska Academy at the University of Gothenburg , M\u00f6lndal , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6193-6193","authenticated-orcid":false,"given":"Johan","family":"Gobom","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & 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":"Joel","family":"Simr\u00e9n","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & 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":"Hanna","family":"Fahl\u00e9n","sequence":"additional","affiliation":[{"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 & 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"}]},{"family":"Andrea Lessa Benedet","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & Physiology, The Sahlgrenska Academy at the University of Gothenburg , M\u00f6lndal , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hlin","family":"Kvartsberg","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & 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":"Henrik","family":"Zetterberg","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Neurochemistry , Institute of Neuroscience & 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 , WI , USA"},{"name":"Wisconsin Alzheimer\u2019s Institute, School of Medicine and Public Health, University of Wisconsin , Madison , WI , USA"},{"name":"Department of Neurodegenerative Disease , Institute of Neurology, University College London , London , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,4,29]]},"reference":[{"key":"2026091512595719966_j_cclm-2026-0370_ref_001","doi-asserted-by":"crossref","unstructured":"Arslan, B, Zetterberg, H, Ashton, NJ. 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JAMA Neurol 2024;81:255\u201363. https:\/\/doi.org\/10.1001\/jamaneurol.2023.5319.","DOI":"10.1001\/jamaneurol.2023.5319"},{"key":"2026091512595719966_j_cclm-2026-0370_ref_004","doi-asserted-by":"crossref","unstructured":"Binks, SN, Graff-Radford, J. Evolving role of plasma phosphorylated Tau 217 in Alzheimer disease\u00a0\u2013\u00a0time for Tau. JAMA Neurol 2025;82:981\u20132. https:\/\/doi.org\/10.1001\/jamaneurol.2025.2972.","DOI":"10.1001\/jamaneurol.2025.2972"},{"key":"2026091512595719966_j_cclm-2026-0370_ref_005","doi-asserted-by":"crossref","unstructured":"Ashton, NJ, Janelidze, S, Mattsson-Carlgren, N, Binette, AP, Strandberg, O, Brum, WS, et al.. Differential roles of A\u03b242\/40, p-tau231 and p-tau217 for Alzheimer\u2019s trial selection and disease monitoring. 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