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

Anne Marie Miller, Aleksandra Rutkowska, Justyna M. Bahl, Sanna Kaisa Herukka, Marleen J A Koel-Simmelink, Niels Kruse, Brit Mollenhauer, Maritta Siloaho, Anders Skinningsrud, Henrik Zetterberg, Charlotte E. Teunissen, Brian A. Lawlor

Research output: Contribution to journalArticleAcademicpeer-review

11 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2243-2254
Number of pages12
JournalBIOANALYSIS
Volume8
Issue number21
DOIs
Publication statusPublished - 1 Nov 2016

Keywords

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

Cite this