NCT05352971

Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients

Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 664 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Biomarker quantification	Patient blood samples will be tested on 2 different platforms

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-04-29
• Last updated: 2023-10-10

Locations

10 sites across 1 country: France