Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 676
- 试验地点
- 2
- 主要终点
- Nasal and Nasopharyngeal Sample Collection
研究概览
简要总结
This study is designed as a prospective, multicentric, sample collection study. The collected samples will be used for diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal and nasopharyngeal swabs by the study sponsor, Abbott.
详细描述
A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference positive subjects and a minimum of 100 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 385 reference-negative subjects will be enrolled. In order to meet these minimum numbers it is anticipated that approximately 2000 subjects will be enrolled in total.
Subjects should be enrolled from point of care for this study. After informed consent has been obtained, operators will collect one nasal swab from both nostrils from each Subject. Every second subject will be asked to blow their nose first and this will be recorded.
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril.
The collected swab will be returned to a plastic tube (provided by the sponsor) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel. Touching of the tube wall with the swab should be avoided. Nasal samples must be collected prior to the Nasopharyngeal sampling.
After the nasal sampling, the operators will collect a nasopharyngeal swab from one nostril of each subject. The NP swab will be returned to a plastic tube (provided by the sponsor) by study staff (touching the tube walls should be avoided) and immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later testing with the Panbio™ Rapid Panel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects >14 years of age who are able and willing to provide written informed consent, and deemed suitable for nasopharyngeal sampling in accordance with local procedures, suspected of having a respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.
排除标准
- •• Subject has had a nasal or a nasopharyngeal swab taken within the last 4 hours.
- •Subject has active nose bleeds or acute facial injuries/trauma
- •Subject has received a nasal vaccine (i.e., FluMist®) within the previous five (5) days.
- •Subject is currently taking or has taken an antiviral medication-i.e., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza within the previous thirty (30) days.
- •Subject is currently enrolled in a study to evaluate an investigational drug.
- •Subject is unwilling or unable to provide informed consent.
- •Vulnerable populations as deemed inappropriate for study by the site's PI and/or reviewing REC.
结局指标
主要结局
Nasal and Nasopharyngeal Sample Collection
时间窗: 6 months
The objective of this study is to collect nasal and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms. The collected samples will be sent to the sponsor (Abbott) or central laboratory for reference testing, diagnostic research, product development and validation of the Panbio™ COVID-19/ Flu A\&B Rapid Panel some of which will be used to support product registrations.
次要结局
未报告次要终点