Inter-assay and Inter-site Performance of Alpha-Synuclein Seed Amplification Assays in Synucleinopathies: A Multicenter 2 × 2 Protocol Comparison - PubMed
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- #Multicenter Study
- #Biomarker Assays
- #Synucleinopathies
- Evaluated performance of two α-synuclein seed amplification assay (synSAA) conditions across two laboratories using a 2×2 design.
- Showcased high inter-site concordance: 100% for SPB-SAA and 95% for PIPES-SAA.
- PIPES-SAA detected synuclein seeds in multiple system atrophy (MSA) with 75-81% sensitivity, while SPB-SAA did not detect MSA but achieved near 100% specificity.
- Inter-assay concordance was high for Parkinson's disease/dementia with Lewy bodies (PD/DLB) and controls (>85%), but low for MSA (31%), reflecting assay differences.
- Supports selecting synSAA condition based on disease context and underscores need for multicenter validation for clinical use.