Journal
BIOANALYSIS
Volume 8, Issue 21, Pages 2243-2254Publisher
FUTURE SCI LTD
DOI: 10.4155/bio-2016-0114
Keywords
biomarker; cerebrospinal fluid; multicenter; neurofilament light; validation
Funding
- Danish Council for Strategic Research
- Academy of Finland
- Bundesministerium fur Bildung und Forschung (BMBF)
- Health Research Board (HRB)
- Swedish Research Council
- Netherlands Organization for Health Research and Development (ZonMw)
- European Research Council
- Swedish State Support for Clinical Research
- Knut and Alice Wallenberg Foundation
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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.
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