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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.
Financial & competing interests disclosure
This work comprised part of the BIOMARKAPD project within the EU Joint Programme – Neurodegenerative Disease Research (JPND). This project is supported through the following funding organizations under the aegis of JPND (www.jpnd.eu): Danish Council for Strategic Research, Academy of Finland, Bundesministerium für Bildung und Forschung (BMBF), Health Research Board (HRB), Swedish Research Council, The Netherlands Organization for Health Research and Development (ZonMw). HZ was also supported by The European Research Council, Swedish State Support for Clinical Research and the Knut and Alice Wallenberg Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The 20 interlaboratory accuracy analysis cerebrospinal fluid samples were collected under local ethics committee approval at the University of Gothenburg; all other cerebrospinal fluid samples used in these experiments were acquired by each participating laboratory in accordance with local research ethics committee requirements. The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations.
Acknowledgements
The authors would like to thank N Norgren and UmanDiagnostics AB, Umeå, Sweden for their support of this work.