Anne-Marie Miller1, Aleksandra Rutkowska1, Justyna M Bahl2, Sanna-Kaisa Herukka3, Marleen Ja Koel-Simmelink4, Niels Kruse5, Brit Mollenhauer6, Maritta Siloaho3, Anders Skinningsrud7, Henrik Zetterberg8,9, Charlotte E Teunissen4, Brian A Lawlor10,11. 1. Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland. 2. Department of Autoimmunology & Biomarkers, Statens Serum Institut, DK-2300, Denmark. 3. Institute of Clinical Medicine, Neurology University of Eastern Finland School of Medicine, Kuopio, Finland. 4. Neurochemistry Laboratory & Biobank, Department of Clinical Chemistry, VU University Medical Center, Neuroscience Amsterdam, The Netherlands. 5. Department of Neuropathology, University Medical Center, Göttingen, Germany. 6. Paracelsus-Elena-Klinik, Kassel and University Medical Center and Institute of Neuropathology and Department of Neurosurgery, Göettingen, Germany. 7. Multidisciplinary Medical Laboratory, Akershus University Hospital, Lørenskog, Norway. 8. Institute of Neuroscience & Physiology, Department of Psychiatry & Neurochemisty, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden. 9. UCL Institute of Neurology, Queen Square, London, UK. 10. Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland. 11. Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin, Ireland.
Abstract
AIM: Neurofilament light (NfL) chain, a putative cerebrospinal fluid biomarker, can support neurodegenerative disease diagnosis and indicate disease severity and prognosis. Universal validation protocols when used to measure biomarkers can reduce pre and analytical laboratory variation, thus increasing end-user confidence in the consistency of validation data across sites. METHODOLOGY: Here, a commercially available NfL ELISA (UmanDiagnostics, Umeå, Sweden) was validated in a multicentered setting using comprehensive newly developed standard operating procedures. RESULTS: The data showed good assay sensitivity and intra and interassay precision. Interlaboratory precision was, however, suboptimal. CONCLUSION: The UmanDiagnostics assay is suitable for the quantification of NfL in human cerebrospinal fluid. However, sources of interlaboratory variation in the data require further investigation.
AIM: Neurofilament light (NfL) chain, a putative cerebrospinal fluid biomarker, can support neurodegenerative disease diagnosis and indicate disease severity and prognosis. Universal validation protocols when used to measure biomarkers can reduce pre and analytical laboratory variation, thus increasing end-user confidence in the consistency of validation data across sites. METHODOLOGY: Here, a commercially available NfL ELISA (UmanDiagnostics, Umeå, Sweden) was validated in a multicentered setting using comprehensive newly developed standard operating procedures. RESULTS: The data showed good assay sensitivity and intra and interassay precision. Interlaboratory precision was, however, suboptimal. CONCLUSION: The UmanDiagnostics assay is suitable for the quantification of NfL in human cerebrospinal fluid. However, sources of interlaboratory variation in the data require further investigation.
Authors: Daniela Rodrigues-Amorim; Tania Rivera-Baltanás; María Del Carmen Vallejo-Curto; Cynthia Rodriguez-Jamardo; Elena de Las Heras; Carolina Barreiro-Villar; María Blanco-Formoso; Patricia Fernández-Palleiro; María Álvarez-Ariza; Marta López; Alejandro García-Caballero; José Manuel Olivares; Carlos Spuch Journal: Sci Rep Date: 2020-08-31 Impact factor: 4.379
Authors: Brit Mollenhauer; Mohammed Dakna; Niels Kruse; Douglas Galasko; Tatiana Foroud; Henrik Zetterberg; Sebastian Schade; Roland G Gera; Wenting Wang; Feng Gao; Mark Frasier; Lana M Chahine; Christopher S Coffey; Andrew B Singleton; Tanya Simuni; Daniel Weintraub; John Seibyl; Arthur W Toga; Caroline M Tanner; Karl Kieburtz; Kenneth Marek; Andrew Siderowf; Jesse M Cedarbaum; Samantha J Hutten; Claudia Trenkwalder; Danielle Graham Journal: Mov Disord Date: 2020-08-15 Impact factor: 9.698