Human Factors and Clinical Validation of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test Using Anterior Nares Nasal Samples for Over-The-Counter (OTC) Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Performance of CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test measured by agreement with RT-PCR
研究概览
简要总结
The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B & COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives are to assess usability and instruction comprehension and reproducibility with untrained operators at Clinical Laboratory Improvement Amendments (CLIA)-waived 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
- Other
- 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
- •Written informed consent obtained prior to study enrollment.
- •Male or female aged 2 years or older.
- •Subjects were tested with a Food Drug and Administration (FDA) cleared molecular assay no more than 2 days prior to the study visit.
- •Subject, aged 2 years or older, is currently exhibiting one or more symptoms associated with COVID-19 or influenza such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea and must present within 5 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.
排除标准
- •Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
- •Subject has had seasonal influenza vaccine within the past 5 days.
- •Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
- •Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- •Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-
- •Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
- •Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
研究组 & 干预措施
Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test
All participants will provide two anterior nares samples. One sample will be tested using the investigational CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test, and the other sample will be tested using a 510(k)-cleared high-sensitivity Reverse transcriptase polymerase chain reaction (RT-PCR) assay for Influenza A/B and SARS-CoV-2. This arm evaluates the diagnostic performance, usability, and reproducibility of the investigational test in lay users.
干预措施: CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test (Device)
结局指标
主要结局
Performance of CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test measured by agreement with RT-PCR
时间窗: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks
The primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At Home Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal (AN) samples collected by lay users. Performance will be assessed by calculating positive percent agreement (PPA), negative percent agreement (NPA), and corresponding 95% confidence intervals, compared to FDA-cleared high-sensitivity RT-PCR tests for Influenza A/B and COVID-19.
次要结局
- Usability of investigational test measured by observation of task completion(The estimated length of the sample collection and testing phase is expected to be 6- 35 weeks)