Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
研究概览
简要总结
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
详细描述
The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval.
The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All patients are assigned a unique study ID number to de-identify them.
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
- •Presence of erythematous skin lesion, consistent with erythema migrans (EM).
- •Age 18 or older.
- •Ability to read, comprehend, and sign the informed consent form.
- •Two (2) or more signs/symptoms of Lyme Disease
排除标准
- •Subject has medically diagnosed bleeding disorder.
- •Having had taken antibiotics in the past 30 days.
- •EM located on face or neck.
- •Unable to provide consent.
结局指标
主要结局
Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
时间窗: 1 day
Qualitative detection of genetic material (DNA) from the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as inclusive Borrelia spp.) from K2EDTA human whole blood samples using the T2Dx instrument and T2Lyme reagents.
次要结局
未报告次要终点