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

• 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Neurosciences (hsv//eng)

Keyword

biomarker

cerebrospinal fluid

multicenter

neurofilament light

validation

AMYOTROPHIC-LATERAL-SCLEROSIS

NEUROCHEMICAL DEMENTIA DIAGNOSTICS

ALZHEIMERS-DISEASE

MULTIPLE-SCLEROSIS

PARKINSONS-DISEASE

CSF

PROTEIN

SEVERITY

MARKER

IMPACT

Publication and Content Type

ref (subject category)

art (subject category)