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000278027 037__ $$aDZNE-2025-00537
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000278027 1001_ $$0P:(DE-2719)9001805$$aBraeuer, Stefan$$b0$$eFirst author$$udzne
000278027 245__ $$aHigh Agreement Across Laboratories Between Different Alpha-Synuclein Seed Amplification Protocols.
000278027 260__ $$aOxford [u.a.]$$bWiley-Blackwell$$c2025
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000278027 520__ $$aSeed amplification assays (SAA) detect alpha-synuclein (aSYN) pathology in patient biomatrices such as cerebrospinal fluid (CSF)-potentially even before clinical manifestations. As CSF-based SAA are approaching broader use in clinical trials and research, ensuring that different laboratories obtain the same results becomes increasingly important.In this cross-laboratory, cross-aSYN-recombinant substrate and cross-protocol round-robin test, we compared SAA results from a common set of 38 CSF samples measured independently in four research laboratories of the German Center for Neurodegenerative diseases. Three laboratories (A-C) used an assay protocol adapted from Parchi's group at ISNB (Bologna, Italy); laboratory D used an assay protocol adapted from Amprion Inc. Two different manufacturers of aSYN protein were used as substrates for the SAA reaction.Qualitative results were identical in at least three of the four laboratories for 37 out of 38 samples (20 positive, 17 negative). Fleiss Kappa for all four laboratories was 0.751 (z = 12, p < 0.001). For each laboratory, agreement with laboratory A was > 92%. For the number of positive replicates, Fleiss Kappa was 0.45 for a score of zero positive replicates and 0.42 for a score of four positive replicates.The qualitative SAA results showed a high level of agreement across research laboratories, aSYN monomers, and assay protocols. Small differences between laboratories were systematic, consistent with the notion that SAA reports biologically relevant properties. These results also underline that round-robin tests can be helpful in assessing and ensuring SAA quality across laboratories.
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000278027 650_7 $$2Other$$aRT‐QuIC
000278027 650_7 $$2Other$$aalpha‐synuclein
000278027 650_7 $$2Other$$amethod validation
000278027 650_7 $$2Other$$aproficiency testing
000278027 650_7 $$2Other$$aring trial
000278027 650_7 $$2NLM Chemicals$$aalpha-Synuclein
000278027 650_2 $$2MeSH$$aHumans
000278027 650_2 $$2MeSH$$aalpha-Synuclein: cerebrospinal fluid
000278027 650_2 $$2MeSH$$aalpha-Synuclein: genetics
000278027 650_2 $$2MeSH$$aLaboratories: standards
000278027 650_2 $$2MeSH$$aReproducibility of Results
000278027 7001_ $$aWeber, Maximilian$$b1
000278027 7001_ $$0P:(DE-2719)2812432$$aDeuschle, Christian$$b2$$udzne
000278027 7001_ $$aJulia, Kühlwein$$b3
000278027 7001_ $$aConcha-Marambio, Luis$$b4
000278027 7001_ $$0P:(DE-2719)9002620$$aBernhardt, Alexander Maximilian$$b5$$udzne
000278027 7001_ $$0P:(DE-2719)9001916$$aKadam, Vaibhavi$$b6
000278027 7001_ $$0P:(DE-2719)9000375$$aMengel, David$$b7$$udzne
000278027 7001_ $$0P:(DE-2719)9001522$$aRuf, Wolfgang P$$b8$$udzne
000278027 7001_ $$0P:(DE-2719)9001967$$aKassubek, Jan$$b9
000278027 7001_ $$0P:(DE-2719)9000748$$aSchniewind, Inaki$$b10
000278027 7001_ $$0P:(DE-2719)2811186$$aKuhs, Sandra$$b11$$udzne
000278027 7001_ $$aRossi, Marcello$$b12
000278027 7001_ $$00000-0002-9444-9524$$aParchi, Piero$$b13
000278027 7001_ $$0P:(DE-2719)2811659$$aLevin, Johannes$$b14$$udzne
000278027 7001_ $$0P:(DE-2719)9001513$$aDanzer, Karin M$$b15$$udzne
000278027 7001_ $$0P:(DE-2719)2811275$$aSynofzik, Matthis$$b16
000278027 7001_ $$0P:(DE-2719)2811916$$aBrockmann, Kathrin$$b17$$udzne
000278027 7001_ $$0P:(DE-2719)2814178$$aFalkenburger, Björn$$b18$$eLast author$$udzne
000278027 773__ $$0PERI:(DE-600)2020241-6$$a10.1111/ene.70165$$gVol. 32, no. 4$$n4$$pe70165$$tEuropean journal of neurology$$v32$$x1351-5101$$y2025
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