Evaluation of Clinical Sample Collection Project: Spartan COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Asses the % agreement between predicate results and Spartan COVID-19 results.
研究概览
简要总结
This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.
详细描述
Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.
The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.
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
- •must have tested positive for COVID-19 via the existing nucleic acid testing method.
排除标准
- 未提供
研究组 & 干预措施
Method 4: Collection of nasal sample.
Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.
干预措施: Spartan COVID-19 System (Device)
Method 1- Nasopharyngeal Swab in transfer liquid
A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
干预措施: Spartan COVID-19 System (Device)
Method 2- Dipping of specialized swab in VTM
A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.
干预措施: Spartan COVID-19 System (Device)
Method 3: Direct input of VTM
Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
干预措施: Spartan COVID-19 System (Device)
结局指标
主要结局
Asses the % agreement between predicate results and Spartan COVID-19 results.
时间窗: Through study completion; anticipated to be less than 6 months.
The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.
次要结局
未报告次要终点