Serum Neurofilament Light Chain Measurement Protocol
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Corresponding Organization : Johannes Gutenberg University Mainz
Other organizations : Heinrich Heine University Düsseldorf
Variable analysis
- Treatment (ocrelizumab or natalizumab)
- NfL levels
- Time to follow-up (mean of 9.9 months for the overall sample and 8.8 months for the subset with both baseline and follow-up values)
- Standardized protocol for NfL assessment (using SiMoA HD-1 and Nf-Light Advantage Kits)
- Intra-assay coefficient of variation (CV) below 20% for all replicates (mean intra-assay CV of 6.8%)
- Inclusion of low and high controls to monitor plate-to-plate variation (low control mean = 3.0 pg/ml, inter-assay CV = 4.0%; high control mean = 132.1 pg/ml, inter-assay CV = 6.9%)
- NfL measurements performed blinded and without information on clinical data
- Low and high controls consisting of recombinant human NfL antigen
- No negative controls were explicitly mentioned in the protocol.
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