Multicenter immunoassay validation of cerebrospinal fluid neurofilament light: a biomarker for neurodegeneration.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
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.
Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.
Anne-Marie
AM
Miller
Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.
Aleksandra
A
Rutkowska
Department of Autoimmunology & Biomarkers, Statens Serum Institut, DK-2300, Denmark.
Justyna M
JM
Bahl
Institute of Clinical Medicine, Neurology University of Eastern Finland School of Medicine, Kuopio, Finland.
Sanna-Kaisa
SK
Herukka
Neurochemistry Laboratory & Biobank, Department of Clinical Chemistry, VU University Medical Center, Neuroscience Amsterdam, The Netherlands.
Marleen Ja
MJ
Koel-Simmelink
Department of Neuropathology, University Medical Center, Göttingen, Germany.
Niels
N
Kruse
Paracelsus-Elena-Klinik, Kassel and University Medical Center and Institute of Neuropathology and Department of Neurosurgery, Göettingen, Germany.
Brit
B
Mollenhauer
Institute of Clinical Medicine, Neurology University of Eastern Finland School of Medicine, Kuopio, Finland.
Maritta
M
Siloaho
Multidisciplinary Medical Laboratory, Akershus University Hospital, Lørenskog, Norway.
Anders
A
Skinningsrud
Institute of Neuroscience & Physiology, Department of Psychiatry & Neurochemisty, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.|UCL Institute of Neurology, Queen Square, London, UK.
Henrik
H
Zetterberg
Neurochemistry Laboratory & Biobank, Department of Clinical Chemistry, VU University Medical Center, Neuroscience Amsterdam, The Netherlands.
Charlotte E
CE
Teunissen
Mercer's Institute for Successful Ageing, St James's Hospital, Dublin, Ireland.|Trinity College Institute of Neuroscience, Trinity College Dublin, Dublin, Ireland.
Brian A
BA
Lawlor
D015415:Biomarkers / Q000134:cerebrospinal fluid*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007753:Laboratories / Q000592:standards*; D057230:Limit of Detection; D019636:Neurodegenerative Diseases / Q000134:cerebrospinal fluid* / Q000175:diagnosis; D016900:Neurofilament Proteins / Q000134:cerebrospinal fluid*; D015203:Reproducibility of Results
D015415:Biomarkers; D016900:Neurofilament Proteins; C044882:neurofilament protein L
biomarker; cerebrospinal fluid; multicenter; neurofilament light; validation