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

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

Cite this

Miller, Anne Marie ; Rutkowska, Aleksandra ; Bahl, Justyna M. ; Herukka, Sanna Kaisa ; Koel-Simmelink, Marleen J A ; Kruse, Niels ; Mollenhauer, Brit ; Siloaho, Maritta ; Skinningsrud, Anders ; Zetterberg, Henrik ; Teunissen, Charlotte E. ; Lawlor, Brian A. / Multicenter immunoassay validation of cerebrospinal fluid neurofilament light : A biomarker for neurodegeneration. In: Bioanalysis. 2016 ; Vol. 8, No. 21. pp. 2243-2254.
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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, Ume{\aa}, 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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author = "Miller, {Anne Marie} and Aleksandra Rutkowska and Bahl, {Justyna M.} and Herukka, {Sanna Kaisa} and Koel-Simmelink, {Marleen J A} and Niels Kruse and Brit Mollenhauer and Maritta Siloaho and Anders Skinningsrud and Henrik Zetterberg and Teunissen, {Charlotte E.} and Lawlor, {Brian A.}",
year = "2016",
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Miller, AM, Rutkowska, A, Bahl, JM, Herukka, SK, Koel-Simmelink, MJA, Kruse, N, Mollenhauer, B, Siloaho, M, Skinningsrud, A, Zetterberg, H, Teunissen, CE & Lawlor, BA 2016, 'Multicenter immunoassay validation of cerebrospinal fluid neurofilament light: A biomarker for neurodegeneration' Bioanalysis, vol. 8, no. 21, pp. 2243-2254. https://doi.org/10.4155/bio-2016-0114

Multicenter immunoassay validation of cerebrospinal fluid neurofilament light : A biomarker for neurodegeneration. / Miller, Anne Marie; Rutkowska, Aleksandra; Bahl, Justyna M.; Herukka, Sanna Kaisa; Koel-Simmelink, Marleen J A; Kruse, Niels; Mollenhauer, Brit; Siloaho, Maritta; Skinningsrud, Anders; Zetterberg, Henrik; Teunissen, Charlotte E.; Lawlor, Brian A.

In: Bioanalysis, Vol. 8, No. 21, 01.11.2016, p. 2243-2254.

Research output: Contribution to journalArticleAcademicpeer-review

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

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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.

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