TY  - JOUR
AU  - Braeuer, Stefan
AU  - Weber, Maximilian
AU  - Deuschle, Christian
AU  - Julia, Kühlwein
AU  - Concha-Marambio, Luis
AU  - Bernhardt, Alexander Maximilian
AU  - Kadam, Vaibhavi
AU  - Mengel, David
AU  - Ruf, Wolfgang P
AU  - Kassubek, Jan
AU  - Schniewind, Inaki
AU  - Kuhs, Sandra
AU  - Rossi, Marcello
AU  - Parchi, Piero
AU  - Levin, Johannes
AU  - Danzer, Karin M
AU  - Synofzik, Matthis
AU  - Brockmann, Kathrin
AU  - Falkenburger, Björn
TI  - High Agreement Across Laboratories Between Different Alpha-Synuclein Seed Amplification Protocols.
JO  - European journal of neurology
VL  - 32
IS  - 4
SN  - 1351-5101
CY  - Oxford [u.a.]
PB  - Wiley-Blackwell
M1  - DZNE-2025-00537
SP  - e70165
PY  - 2025
AB  - 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
KW  - Humans
KW  - alpha-Synuclein: cerebrospinal fluid
KW  - alpha-Synuclein: genetics
KW  - Laboratories: standards
KW  - Reproducibility of Results
KW  - RT‐QuIC (Other)
KW  - alpha‐synuclein (Other)
KW  - method validation (Other)
KW  - proficiency testing (Other)
KW  - ring trial (Other)
KW  - alpha-Synuclein (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:40237217
DO  - DOI:10.1111/ene.70165
UR  - https://pub.dzne.de/record/278027
ER  -