HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens
研究概览
简要总结
This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).
详细描述
The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Clinical Sites and the Reference Core-Lab will be masked of specimen disease state
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Specimens:
- •Male or female
- •Biorepository specimen de-identified of PHI
- •Specimen meets HTLV Blot 2.4 labeling collection/handling criteria
- •HTLV Positive Specimens:
- •Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II
- •Neurological Disorders:
- •Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:
- •Acute Disseminated Encephalitis
- •Amyotrophic Lateral Sclerosis (ALS)
- •Autonomic Dysfunction
- •Conus Medularis Syndrome
- •Chronic Inflammatory Demyelinating Polyneuropathy
- •Dermatomyositis
- •HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP)
- •Meningitis
- •Mild Cognitive Impairment
- •Multiple Sclerosis (MS)
- •Polymyositis
- •Spastic Paraparesis
排除标准
- •HTLV Infected:
- •specimens with a known infection or history of HIV, HCV or HBV
- •specimens not meeting specimen labeling collection / handling criteria
- •Neurological Disorders
- •specimens not meeting specimen labeling collection / handling criteria
研究组 & 干预措施
HTLV Infected (n=50)
Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)
干预措施: MP Diagnostics HTLV Blot 2.4 (Diagnostic Test)
Neurological Disorders (n=100)
Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica
干预措施: MP Diagnostics HTLV Blot 2.4 (Diagnostic Test)
结局指标
主要结局
To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens
时间窗: 3 months
To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens
时间窗: 3 months
次要结局
未报告次要终点