Multicenter immunoassay validation of cerebrospinal fluid neurofilament light: a biomarker for neurodegeneration. (November 2016)

• Record Type: Journal Article
• Authors: Miller, Anne-Marie; Rutkowska, Aleksandra; Bahl, Justyna M; Herukka, Sanna-Kaisa; Koel-Simmelink, Marleen JA; Kruse, Niels; Mollenhauer, Brit; Siloaho, Maritta; Skinningsrud, Anders; Zetterberg, Henrik; Teunissen, Charlotte E; Lawlor, Brian A
• Is Part Of: Bioanalysis. Volume 8:Number 21(2016)
• Page Start: 2243
• Page End: 2254
• Publication Date: 2016-11
• Subjects: biomarker -- cerebrospinal fluid -- multicenter -- neurofilament light -- validation; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0114
• Languages: English
• ISSNs: 1757-6180

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.