Serum neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP) measured by single molecule array (SIMOA) are novel biomarkers of multiple sclerosis patients (MS) activity and progression. Its use is limited due to low availability and high costs. ELLA is a cheaper platform with increasing availability. Recently, we compared SIMOA and ELLA platforms to assess serum NfL levels in 203 MS patients from the OFSEP-HD study. There was a strong correlation (Spearman r = 0.86, p \< 0.0001) between both platforms. As for SIMOA, serum NfL levels measured by ELLA were correlated with age and EDSS and were significantly higher in active MS, suggesting that these assays are equivalent and can be used in any center for routine care. However, the accuracy of local measures acquired with ELLA has not been determined. The aim os this study is to assess the concordance of multi-site ELLA instruments, accuracy of GFAP measures as compared to SIMOA, and the predictive value of NfL and GFAP measured by ELLA in MS.
Study Type
OBSERVATIONAL
Enrollment
664
Patient blood samples will be tested on 2 different platforms
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Henri Mondor
Créteil, France
CHRU Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
CHU Gui de Chauliac
Montpellier, France
CHU de Nantes,
Nantes, France
Centre Hospitalier Universitaire Pasteur 2
Nice, France
CHU de Nîmes
Nîmes, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU de Strasbourg
Strasbourg, France
Inter-laboratory reproducibility of neurofilament-light chain level measurements
Coefficients of variation will be calculated in 30 patients
Time frame: Day 0
Inter-laboratory repeatability of neurofilament-light chain level measurements
Serum from 3 patients with low, medium or high levels of NfL will be tested 10 times
Time frame: Day 0
Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements
Coefficients of variation will be calculated in 30 patients
Time frame: Day 0
Inter-laboratory repeatability of glial fibrillary acidic protein level measurements
Serum from 3 patients with low, medium or high levels of GFAP will be tested 10 times
Time frame: Day 0
compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients
Intraclass concordance correlation coefficient and Passing-Bablock analysis calculated in 210 patients
Time frame: Day 0
to build a "global disease activity score"
Logistic regression to predict active multiple sclerosis
Time frame: Day 0
to build a "global disability score"
Logistic regression to predict Expanded Disability Status Scale score
Time frame: Day 0
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