Clinical 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
- 入组人数
- 2,472
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
This study is designed as a prospective, multicentric, clinical study to investigate the performance 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 swabs.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
详细描述
After obtaining written informed consent, a study-specific participant identification number (ID) will be assigned to the participant. Participant demographics and a brief medical history will be collected.
One nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP (general practitioner) centre or hospital clinic). Each Panbio™ COVID-19/ Flu A&B Rapid Panel result will be photographed by the observer at the time of test interpretation.
Nasopharyngeal samples will be collected and used for RT-PCR (Reverse transcription polymerase chain reaction) testing as per local procedures.
Nasal samples must always be collected prior to the Nasopharyngeal sampling. A minimum of 90 Flu A positive subjects, a minimum of 90 Flu B positive subjects and a minimum of 100 SARS-CoV-2 positive subjects will be enrolled. In addition, a minimum of 385 negative subjects will be enrolled.
In total, a minimum of 665 male and female subjects will be prospectively enrolled at multiple clinical sites.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Subjects from all age groups, able and willing to provide written informed consent or assent, suspected of having a respiratory viral infection consistent with COVID-19 and or Flu by their healthcare provider within the first seven 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 (Research Ethics Committee).
结局指标
主要结局
Sensitivity and Specificity
时间窗: 8 months
Sensitivity of 70% is the target at the lower bound of the 95% confidence interval for SARS-CoV-2 and 70% for each Flu. The target specificity is 95% at the lower bound of the 95% confidence interval for each test line.
次要结局
- Usability(8 months)