Multi-Site Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 664
- 试验地点
- 10
- 主要终点
- Inter-laboratory repeatability of neurofilament-light chain level measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from the OFSEP HD cohort.
- •At least one native (no thaw-freeze cycle) serum sample in local or in centralized Biological Resource Center
排除标准
- •No bio-collection or insufficient sample volume
- •No OFSEP minimal sheet at baseline
结局指标
主要结局
Inter-laboratory repeatability of neurofilament-light chain level measurements
时间窗: Day 0
Serum from 3 patients with low, medium or high levels of NfL will be tested 10 times
Inter-laboratory repeatability of glial fibrillary acidic protein level measurements
时间窗: Day 0
Serum from 3 patients with low, medium or high levels of GFAP will be tested 10 times
Inter-laboratory reproducibility and repeatability of glial fibrillary acidic protein level measurements
时间窗: Day 0
Coefficients of variation will be calculated in 30 patients
Inter-laboratory reproducibility of neurofilament-light chain level measurements
时间窗: Day 0
Coefficients of variation will be calculated in 30 patients
次要结局
- compare the GFAP values obtained using the ELLA and SIMOA platforms in MS patients(Day 0)
- to build a "global disease activity score"(Day 0)
- to build a "global disability score"(Day 0)