TY - JOUR
T1 - Multicenter immunoassay validation of cerebrospinal fluid neurofilament light
T2 - A biomarker for neurodegeneration
AU - Miller, Anne Marie
AU - Rutkowska, Aleksandra
AU - Bahl, Justyna M.
AU - Herukka, Sanna Kaisa
AU - Koel-Simmelink, Marleen J A
AU - Kruse, Niels
AU - Mollenhauer, Brit
AU - Siloaho, Maritta
AU - Skinningsrud, Anders
AU - Zetterberg, Henrik
AU - Teunissen, Charlotte E.
AU - Lawlor, Brian A.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - 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.
AB - 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.
KW - biomarker
KW - cerebrospinal fluid
KW - multicenter
KW - neurofilament light
KW - validation
UR - http://www.scopus.com/inward/record.url?scp=84990821410&partnerID=8YFLogxK
U2 - https://doi.org/10.4155/bio-2016-0114
DO - https://doi.org/10.4155/bio-2016-0114
M3 - Article
C2 - 27684648
SN - 1757-6180
VL - 8
SP - 2243
EP - 2254
JO - Bioanalysis
JF - Bioanalysis
IS - 21
ER -