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@ARTICLE{Braeuer:278027,
      author       = {Braeuer, Stefan and Weber, Maximilian and Deuschle,
                      Christian and Julia, Kühlwein and Concha-Marambio, Luis and
                      Bernhardt, Alexander Maximilian and Kadam, Vaibhavi and
                      Mengel, David and Ruf, Wolfgang P and Kassubek, Jan and
                      Schniewind, Inaki and Kuhs, Sandra and Rossi, Marcello and
                      Parchi, Piero and Levin, Johannes and Danzer, Karin M and
                      Synofzik, Matthis and Brockmann, Kathrin and Falkenburger,
                      Björn},
      title        = {{H}igh {A}greement {A}cross {L}aboratories {B}etween
                      {D}ifferent {A}lpha-{S}ynuclein {S}eed {A}mplification
                      {P}rotocols.},
      journal      = {European journal of neurology},
      volume       = {32},
      number       = {4},
      issn         = {1351-5101},
      address      = {Oxford [u.a.]},
      publisher    = {Wiley-Blackwell},
      reportid     = {DZNE-2025-00537},
      pages        = {e70165},
      year         = {2025},
      abstract     = {Seed 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.},
      keywords     = {Humans / alpha-Synuclein: cerebrospinal fluid /
                      alpha-Synuclein: genetics / Laboratories: standards /
                      Reproducibility of Results / RT‐QuIC (Other) /
                      alpha‐synuclein (Other) / method validation (Other) /
                      proficiency testing (Other) / ring trial (Other) /
                      alpha-Synuclein (NLM Chemicals)},
      cin          = {AG Falkenburger / Clinical Research (Munich) / AG Gasser /
                      AG Danzer / Clinical Study Center (Ulm) / AG Spottke / AG
                      Levin},
      ddc          = {610},
      cid          = {I:(DE-2719)1710012 / I:(DE-2719)1111015 /
                      I:(DE-2719)1210000 / I:(DE-2719)5000072 / I:(DE-2719)5000077
                      / I:(DE-2719)1011103 / I:(DE-2719)1111016},
      pnm          = {353 - Clinical and Health Care Research (POF4-353) / 352 -
                      Disease Mechanisms (POF4-352)},
      pid          = {G:(DE-HGF)POF4-353 / G:(DE-HGF)POF4-352},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40237217},
      doi          = {10.1111/ene.70165},
      url          = {https://pub.dzne.de/record/278027},
}