Diagnostic Performance of the α-Synuclein Seed Amplification Assay for Dementia With Lewy Bodies
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Le résumé fourni par la source
BACKGROUND AND OBJECTIVES: The α-synuclein (α-syn) seed amplification assay (SAA) has shown promising results for diagnosing dementia with Lewy bodies (DLB) using CSF samples. A barrier to implementing α-syn SAA clinically is the use of different protocols for the assay. It is unknown how different protocols perform in comparison with each other. We compared the performance of α-syn SAA across 4 laboratories using CSF samples of patients with DLB. METHODS: This was a retrospective cross-sectional study that included data from 4 different European laboratories. We included probable patients with DLB with a positive dopamine transporter (DaT)-SCAN and known amyloid-β status who had mild-to-moderate dementia, along with age-matched and sex-matched controls. The α-syn SAA was run across 4 laboratories using different protocols varying α-syn concentration and plate reader settings. CSF samples were provided by a fifth independent laboratory, which also performed statistical and result analyses. RESULTS: We included 20 patients with DLB (mean age 67 ± 6 years, 60% male) and 10 controls (mean age 67 ± 2 years, 70% male). Neuropathologic confirmation was available for 2 patients with DLB. On average, the 4 laboratories achieved 78.8% sensitivity (minimum 55%, maximum 100%), 77.5% specificity (minimum 60%, maximum 100%), and 78.5% accuracy (minimum 57%, maximum 100%) for discriminating DLB from controls, but our findings show that diagnostic performance of SAA varied across laboratories: Lab A achieved 100% sensitivity (CI 84%-100%) and 100% specificity (CI 72%-100%); Lab B achieved 85% sensitivity (CI 64%-95%) and 90% specificity (CI 59%-99%); Lab C achieved 55% sensitivity (CI 34%-74%) and 60% specificity (CI 31%-83%); and Lab D achieved 75% sensitivity (CI 53%-89%) and 60% specificity (CI 31%-83%). In general, SAA results showed numerically lower sensitivity in β-amyloid (Aβ)-positive patients with DLB (70%) compared with Aβ-negative patients with DLB (87.5%) (nonstatistically significant). A fair agreement of SAA results was obtained across the 4 laboratories (average κ = 0.246). DISCUSSION: This study highlights challenges for the reproducibility of α-syn SAA results across different protocols applied by different laboratories. This finding, together with the methodological variability reported across laboratories, may challenge the clinical implementation of the α-syn SAA. This study provides relevant support for initiating harmonization and standardization of SAA protocols to move the field toward the clinical implementation of SAAs for the biomarker-based diagnosis of DLB. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence of variations in the accuracy of CSF α-syn SAA across 4 separate laboratories in distinguishing patients with DLB from healthy controls.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Diagnostic Performance of the α-Synuclein Seed Amplification Assay for Dementia With Lewy Bodies
- Date Crossref
- 24/02/2026
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Karolinska Institutet Department of Medicine Huddinge pays non établi dans la noticeUniversité ou école supérieure
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Karolinska University Hospital Cognitive Disorders Clinic pays non établi dans la noticeÉtablissement de santé
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Stavanger University Hospital Centre for Movement Disorders pays non établi dans la noticeÉtablissement de santé
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Centre for Movement Disorders pays non établi dans la noticeÉtablissement de santé
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University of Stavanger Department of Chemistry pays non établi dans la noticeUniversité ou école supérieure
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Fondazione IRCCS Istituto Neurologico Carlo Besta pays non établi dans la noticeÉtablissement de santé
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Hôpital d'Hautepierre pays non établi dans la noticeÉtablissement de santé
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Centre National de la Recherche Scientifique pays non établi dans la noticeOrganisme public
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Inserm pays non établi dans la noticeOrganisme public
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Institut de génétique et de biologie moléculaire et cellulaire pays non établi dans la noticeStructure de recherche
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Biologie Structurale Intégrée pays non établi dans la noticeStructure de recherche
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Université de Strasbourg pays non établi dans la noticeUniversité ou école supérieure
Department of Medicine Huddinge — Karolinska Institutet, Cognitive Disorders Clinic — Karolinska University Hospital et Centre for Movement Disorders — Stavanger University Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.