Multi-center Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 447
- 试验地点
- 2
- 主要终点
- Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA
研究概览
简要总结
The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.
详细描述
Approximately 2,000 symptomatic Participants to achieve at least 80 COVID-19 PCR confirmed positives, 80 Flu A PCR confirmed positives, 80 Flu B PCR confirmed positives, and 500 COVID-19 and Influenza PCR-confirmed negatives.
Site staff will collect two (2) anterior nasal swabs from each Participant from whom informed consent has been obtained. Participants ages two (2) years and older meeting eligibility criteria will be enrolled.
One anterior nasal swab will be immediately eluted in an extraction buffer tube and tested with the Panbio™ COVID-19/Flu A&B Panel. If immediate testing is not possible, the swab specimen can be kept in an extraction buffer tube filled with extraction buffer at room temperature (59-86°F /15-30 °C) for up to one (1) hour prior to testing.
The other anterior nasal swab will be rotated vigorously in VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary.
Anterior nasal swab sample collection will be as follows:
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is suspected of acute viral respiratory infection by a healthcare professional, and
- •Participant is age two (2) years or older, and
- •Participant is within seven (7) days of symptom onset, and
- •Participant is experiencing two or more of the following symptoms:
- •Fever of >100.0°F/ 37.8°C
- •New loss of taste or smell
- •Congestion or runny nose
- •Shortness of breath or difficulty breathing
- •Sore throat
- •Muscle or body aches
- •Nausea or vomiting
排除标准
- •Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
- •Participants with an active nosebleed
- •Participant has undergone a nasal wash or nasal aspirate procedure on day of enrollment
- •Participant has received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
- •Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
- •Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days
- •Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals, convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
结局指标
主要结局
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA
时间窗: "up to 24 months"
1\. Primary Outcome: The primary objective of this study is to demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider. Samples may also be tested for viral culture.
次要结局
- Demonstrate the accuracy of the Panbio™ COVID-19/Flu A&B Panel in the hands of untrained users by a usability questionnaire.("Up to 24 months")