{"id":"doi:10.1038/s41591-025-03622-w","kind":"article","title":"Plasma phospho-tau217 for Alzheimer's disease diagnosis in primary and secondary care using a fully automated platform","authors":["Palmqvist S","Warmenhoven N","Anastasi F","Pilotto A","Janelidze S","Tideman P","Stomrud E","Mattsson-Carlgren N","Smith R","Ossenkoppele R","Tan K","Dittrich A","Skoog I","Zetterberg H","Quaresima V","Tolassi C","Höglund K","Brugnoni D","Puig-Pijoan A","Fernández-Lebrero A","Contador J","Padovani A","Monane M","Verghese PB","Braunstein JB"],"author_count":30,"year":2025,"published":"2025-04-09","venue":"Nature medicine","cited_by":182,"doi":"10.1038/s41591-025-03622-w","arxiv_id":null,"nct_id":null,"source_url":"https://doi.org/10.1038/s41591-025-03622-w","archive_url":"https://space-kitty.com/papers/doi:10.1038/s41591-025-03622-w","updated":null,"pmid":"40205199","pmcid":"PMC12176611","openalex_id":null,"pdf_url":"https://europepmc.org/articles/PMC12176611/pdf","abstract":"Global implementation of blood tests for Alzheimer's disease (AD) would be facilitated by easily scalable, cost-effective and accurate tests. In the present study, we evaluated plasma phospho-tau217 (p-tau217) using predefined biomarker cutoffs. The study included 1,767 participants with cognitive symptoms from 4 independent secondary care cohorts in Malmö (Sweden, n = 337), Gothenburg (Sweden, n = 165), Barcelona (Spain, n = 487) and Brescia (Italy, n = 230), and a primary care cohort in Sweden (n = 548). Plasma p-tau217 was primarily measured using the fully automated, commercially available, Lumipulse immunoassay. The primary outcome was AD pathology defined as abnormal cerebrospinal fluid Aβ42:p-tau181. Plasma p-tau217 detected AD pathology with areas under the receiver operating characteristic curves of 0.93-0.96. In secondary care, the accuracies were 89-91%, the positive predictive values 89-95% and the negative predictive values 77-90%. In primary care, the accuracy was 85%, the positive predictive values 82% and the negative predictive values 88%. Accuracy was lower in participants aged ≥80 years (83%), but was unaffected by chronic kidney disease, diabetes, sex, APOE genotype or cognitive stage. Using a two-cutoff approach, accuracies increased to 92-94% in secondary and primary care, excluding 12-17% with intermediate results. Using the plasma p-tau217:Aβ42 ratio did not improve accuracy but reduced intermediate test results (≤10%). Compared with a high-performing mass-spectrometry-based assay for percentage p-tau217, accuracies were comparable in secondary care. However, percentage p-tau217 had higher accuracy in primary care and was unaffected by age. In conclusion, this fully automated p-tau217 test demonstrates high accuracy for identifying AD pathology. A two-cutoff approach might be necessary to optimize performance across diverse settings and subpopulations.","abstract_license":"CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)","license":"CC-BY","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":[],"details":null,"provenance":"europepmc","attribution":"Abstract of \"Plasma phospho-tau217 for Alzheimer's disease diagnosis in primary and secondary care using a fully automated platform\" by Palmqvist S, Warmenhoven N, Anastasi F et al., https://doi.org/10.1038/s41591-025-03622-w, used under its Creative Commons Attribution license (CC-BY); markup removed, otherwise unmodified.","topics":[{"slug":"neurodegeneration","name":"Alzheimer's, Parkinson's & Neurodegeneration","domain_slug":"medicine"}],"cited_in_dossiers":[]}