Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 903
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device.
研究概览
简要总结
This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
详细描述
In total, a minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites. A minimum of 100 lay users will also be asked to interpret randomly assigned mock devices.
After obtaining written informed consent, a study-specific subject identification number (ID) will be assigned to the subject. All eligible subjects will be assigned to both Professional Use arm and the Self-Test arm of the study. Subject demographics and a brief medical history will be collected.
Lay users (self-tester or caregiver) will first collect one mid-turbinate nasal swab from both nostrils, and perform and interpret the Panbio™ Rapid Panel ST device, under the observation of a trained observer. All procedures for testing and result interpretation, including sample collection and extraction, will be conducted following the IFU provided in the kit. Each Panbio™ Rapid Panel ST result will be interpreted firstly by the lay user and followed immediately by the observer who will also photograph the test at the time of interpretation. Each lay user will fill out a user evaluation questionnaire, and a study staff member will complete an observer questionnaire for each lay user. A minimum of 100 lay users will also read mock device tests presented by a study staff member. Mock devices (simulated to represent testing results) will be used for usability testing (result interpretation).
A study staff member will then collect two NP swabs (one swab from each nostril) from all subjects. The first NP swab sample will be used to conduct a Panbio™ Rapid Panel PU test, following the IFU. The test result will be photographed at the time of result interpretation. Each study staff member who performs a Panbio™ Rapid Panel PU test will fill out a user evaluation questionnaire once, to assess the usability of the device.
The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual.
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
- 否
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 five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, 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 NP swab taken within the last 4 hours and is not available for further testing after 4 hours has elapsed.
- •Subject has active nose bleeds or acute facial injuries/trauma.
- •Subject has received a nasal vaccine (i.e., FluMist®) within the previous fourteen (14) days.
- •Subject is currently taking or has taken an antiviral medication- e.g., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza or COVID-19 within the previous thirty (30) days.
- •Subject is currently enrolled in a study to evaluate an investigational drug.
- •Self-tester or caregiver has prior medical or laboratory training.
- •Self-tester or caregiver has a visual impairment that cannot be restored using glasses or contact lenses or lay user is unable to read the Instructions for Use.
- •Subject has a condition deemed unfit to safely perform the test.
- •Subject is unwilling or unable to provide informed consent.
- •Vulnerable populations as deemed inappropriate for the study by the site's PI.
结局指标
主要结局
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device.
时间窗: "up to 24 months"
To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID-19/Flu A\&B Rapid Panel in fresh collected mid-turbinate nasal 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 in a Near Patient Testing setting, compared to Flu and SARS-CoV-2 RT-PCR tested using NP swab samples. Concordance analyisis of investigational device and reference method. Acceptance criterion: Sensitivity \>80%, Specificity \>95% To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID- 19/Flu A\&B Rapid Panel Self-Test device, as performed by lay users (self-testers or caregivers) using fresh collected mid-turbinate nasal self- collected samples, when compared to Flu and SARS-CoV-2 RT- PCR using NP swab samples.
次要结局
- Usability of the self test device("up to 24 months")
- Concordance of self-test and professional use device("up to 24 months")
- Usability of the professional use device("up to 24 months")