Nasal Swab Objective and Statistical Evaluation (NOSE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,179
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Supply chain disruptions have led to shortages in test swabs which are used to collect respiratory samples. Lack of these test swabs can reduce a hospital or state's ability to test patients for COVID-19.
To address this shortage, many manufacturers, hospitals and individuals have designed non-traditional 3D printed swabs for COVID-19 diagnosis that could potentially meet demands for nasal swabs. However, questions regarding the safety and effectiveness of these swabs remain.
This study will provide additional, statistically supported evidence as to the safety and efficacy of novel swabs.
详细描述
This is a prospective, multi-site, non-inferiority study providing a comparison between the performance of traditional, standard of care (SoC) and alternative (ALT) nasal swabs. Nasal swabs and swabbing site of interest for this study is the nasopharynx (NP swab). The primary outcomes of this study are the rate of adverse events and the agreement in laboratory viral detection between SoC and ALT swabs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Symptomatic or COVID-19 positive (within the past 2 weeks)
- •Has a COVID-19 positive household member
- •Female and male Veterans or female and male VHA employees
- •Able and willing to give informed consent
排除标准
- •Self-reported history of frequent nosebleeds or a diagnosis of coagulopathy or any bleeding disorders
- •Unsuitability for mid-turbinate or nasopharyngeal swabbing due to prior surgery
- •Need for legally authorized representative for purpose of giving consent
研究组 & 干预措施
Standard of Care / Standard of Care
Initial cohort to identify the effect of order on swab result. Swab order (standard of care first) was set to preserve clinical test result in case there was an impact to swab order.
1st Alt Swab / Standard of Care
Evaluation of 1st alternatively sourced swab to the standard of care swab
2nd Alt Swab / Standard of Care
Evaluation of 2nd alternatively sourced swab to the standard of care swab
结局指标
主要结局
Sensitivity
时间窗: Day 1
Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab)
Specificity
时间窗: Day 1
Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab)
次要结局
- Epistaxis rate(Day 1)
- Sensitivity(Day 1)
- Specificity(Day 1)