دورية أكاديمية
Multicenter Analytical Validation of Aβ40 Immunoassays
| العنوان: | Multicenter Analytical Validation of Aβ40 Immunoassays |
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| المؤلفون: | van Waalwijk van Doorn, Linda, Kulic, Luka, Koel-Simmelink, Marleen, Kuiperij, H. Bea, Versleijen, Alexandra, Struyfs, Hanne, Twaalfhoven, Harry, Fourier, Anthony, Engelborghs, Sebastiaan, Perret-Liaudet, Armand, Lehmann, Sylvain, Verbeek, Marcel, Vanmechelen, Eugeen, Teunissen, Charlotte |
| المساهمون: | Radboud University Medical Center Nijmegen, Universität Zürich Zürich = University of Zurich (UZH), VU University Medical Center Amsterdam, Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM) |
| المصدر: | ISSN: 1664-2295 ; Frontiers in Neurology ; https://hal.science/hal-01758275Test ; Frontiers in Neurology, 2017, 8, pp.310. ⟨10.3389/fneur.2017.00310⟩. |
| بيانات النشر: | HAL CCSD Frontiers |
| سنة النشر: | 2017 |
| المجموعة: | HAL Lyon 1 (University Claude Bernard Lyon 1) |
| مصطلحات موضوعية: | Alzheimer’s disease, Immunoassays, amyloid, cerebrospinal fluid, method validation, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology |
| الوصف: | International audience ; Background: Before implementation in clinical practice, biomarker assays need to be thoroughly analytically validated. There is currently a strong interest in implementation of the ratio of amyloid-β peptide 1-42 and 1-40 (Aβ42/Aβ40) in clinical routine. Therefore, in this study, we compared the analytical performance of six assays detecting Aβ40 in cerebrospinal fluid (CSF) in six laboratories according to a recently standard operating procedure (SOP) developed for implementation of ELISA assays for clinical routine.Methods: Aβ40 assays of six vendors were validated in up to three centers per assay according to recently proposed international consensus validation protocols. The performance parameters included sensitivity, precision, dilutional linearity, recovery, and parallelism. Inter-laboratory variation was determined using a set of 20 CSF samples. In addition, test results were used to critically evaluate the SOPs that were used to validate the assays.Results: Most performance parameters of the different Aβ40 assays were similar between labs and within the predefined acceptance criteria. The only exceptions were the out-of-range results of recovery for the majority of experiments and of parallelism by three laboratories. Additionally, experiments to define the dilutional linearity and hook-effect were not executed correctly in part of the centers. The inter-laboratory variation showed acceptable low levels for all assays. Absolute concentrations measured by the assays varied by a factor up to 4.7 for the extremes.Conclusion: All validated Aβ40 assays appeared to be of good technical quality and performed generally well according to predefined criteria. A novel version of the validation SOP is developed based on these findings, to further facilitate implementation of novel immunoassays in clinical practice. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/28725210; hal-01758275; https://hal.science/hal-01758275Test; https://hal.science/hal-01758275/documentTest; https://hal.science/hal-01758275/file/fneur-08-00310.pdfTest; PUBMED: 28725210; PUBMEDCENTRAL: PMC5497061 |
| DOI: | 10.3389/fneur.2017.00310 |
| الإتاحة: | https://doi.org/10.3389/fneur.2017.00310Test https://hal.science/hal-01758275Test https://hal.science/hal-01758275/documentTest https://hal.science/hal-01758275/file/fneur-08-00310.pdfTest |
| حقوق: | http://creativecommons.org/licenses/byTest/ ; info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.31C3813D |
| قاعدة البيانات: | BASE |
| DOI: | 10.3389/fneur.2017.00310 |
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