A new enzyme-linked immunosorbent assay for neurofilament light in cerebrospinal fluid: analytical validation and clinical evaluation

Autor: Lorenzo Gaetani, Kina Höglund, Lucilla Parnetti, Fani Pujol-Calderon, Bruno Becker, Paolo Eusebi, Paola Sarchielli, Paolo Calabresi, Massimiliano Di Filippo, Henrik Zetterberg, Kaj Blennow
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Alzheimer’s Research & Therapy, Vol 10, Iss 1, Pp 1-13 (2018)
Druh dokumentu: article
ISSN: 1758-9193
DOI: 10.1186/s13195-018-0339-1
Popis: Abstract Background Cerebrospinal fluid (CSF) neurofilament light (NfL) is a reliable marker of neuro-axonal damage in different neurological disorders that is related to disease severity. To date, all recent studies performed in human CSF have used the same enzyme-linked immunosorbent assay (ELISA). To confirm the large body of evidence for NfL, we developed a new ELISA method and here we present the performance characteristics of this new ELISA for CSF NfL in different neurological disorders. Methods We produced two monoclonal antibodies (NfL21 and NfL23) directed against the NfL core domain, and developed a novel sandwich ELISA method that we evaluated in patients with: 1) inflammatory demyelinating diseases (IDD; n = 97), including multiple sclerosis (MS; n = 59), clinically isolated syndrome (CIS; n = 32), and radiologically isolated syndrome (RIS; n = 6); 2) Alzheimer’s disease (AD; n = 72), including mild cognitive impairment due to AD (MCI-AD, n = 36) and probable AD dementia (AD-dem; n = 36); 3) Parkinson’s disease (PD; n = 30); and 4) other neurological noninflammatory and non-neurodegenerative diseases (OND; n = 30). Results Our new NfL ELISA showed a good analytical performance (inter-plate coefficient of variation (CV)
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