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

作者：Miller Anne Marie; Rutkowska Aleksandra; Bahl Justyna M; Herukka Sanna Kaisa; Koel Simmelink Marleen J A; Kruse Niels; Mollenhauer Brit; Siloaho Maritta; Skinningsrud Anders; Zetterberg Henrik; Teunissen Charlotte E; Lawlor Brian A^*

来源：Bioanalysis, 2016, 8(21): 2243-2254.

DOI：10.4155/bio-2016-0114

• biomarker
• cerebrospinal fluid
• multicenter
• neurofilament light
• validation

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, Ume dagger, 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.

• 出版日期2016-11