NCT07308158已完成不适用
Human Factors and Clinical Validation of the iHealth Labs Inc iHealth Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use
iHealth Labs inc45 个研究点 分布在 2 个国家目标入组 1,119 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,119
- 试验地点
- 45
- 主要终点
- Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B, SARS-CoV-2 and Respiratory Syncytial Virus Compared to an FDA-Cleared Reference Method
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.
The main questions it aims to answer are:
- What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, , SARS-CoV-2 and respiratory syncytial virus antigen.
- What is the overall positive and negative percent agreement between the investigational test and the reference method?
Participants will:
- Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
- Provide an additional specimen for testing with the FDA-cleared reference method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 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 six (6) months or older.
- •Subject is currently exhibiting two or more symptoms associated with COVID-19, influenza or RSV (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 six (6) 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 and/or the SARS-CoV-2 and/or the RSV 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®), or 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 taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
- •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.
结局指标
主要结局
Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B, SARS-CoV-2 and Respiratory Syncytial Virus Compared to an FDA-Cleared Reference Method
时间窗: Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)
次要结局
未报告次要终点
研究者
研究点 (45)
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