期刊
AMYOTROPHIC LATERAL SCLEROSIS AND FRONTOTEMPORAL DEGENERATION
卷 17, 期 5-6, 页码 404-413出版社
TAYLOR & FRANCIS LTD
DOI: 10.3109/21678421.2016.1167913
关键词
Cerebrospinal fluid; neurofilament; biomarker; amyotrophic lateral sclerosis; round robin
资金
- JPND networks SOPHIA [01ED1202A]
- BiomarkAPD [01ED1203F]
- German Federal Ministry of Education and Research [FTLDc O1GI1007A, KKMS, MND-Net 01GM1103A, PYRAMID 01GM1304]
- EU [NADINE 246513, FAIR-PARK II 633190]
- foundation of the state Baden-Wurttemberg [D.3830]
- BIU [D.5009]
- Scientific and Technological Research Council of Turkey [TUBITAK 112S362]
- E-rare grant PYRAMID [E-rare 12-093]
- Medical Research Council & Motor Neurone Disease Association Lady Edith Wolfson Senior Clinical Fellowship [MR/K01014X/1]
- Medical Research Council [MR/K01014X/1, MR/K000039/1, G0701923, MR/K000780/1] Funding Source: researchfish
- Motor Neurone Disease Association [Turner/Jan13/944-795] Funding Source: researchfish
- MRC [MR/K000039/1, G0701923, MR/K000780/1, MR/K01014X/1] Funding Source: UKRI
OBJECTIVE: Neurofilaments are leading neurochemical biomarkers for amyotrophic lateral sclerosis (ALS). Here, we investigated the effect of preanalytical factors on neurofilament concentrations in cerebrospinal fluid (CSF) in a reverse round-robin with 15 centers across Europe/U.S. METHODS: Samples from ALS and control patients (5/5 each center, n=150) were analyzed for phosphorylated neurofilament heavy chain (pNfH) and neurofilament light chain (NfL) at two laboratories. RESULTS: CSF pNfH was increased (p<0.05) in ALS in 10 out of 15 centers and NfL in 5 out of 12 centers. The coefficient of variation (CV%) of pNfH measurements between laboratories was 18.7 +/- 19.1%. We calculated a diagnostic cut-off of >568.5pg/mL for pNfH (sensitivity 78.7%, specificity 93.3%) and >1,431pg/mL for NfL (sensitivity 79.0%, specificity 86.4%). CONCLUSION: Values in ALS patients are already comparable between most centers, supporting eventual implementation into clinical routine. However, continuous quality control programs will be necessary for inclusion in the diagnostic work-up.
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