Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 8
- 主要终点
- Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
研究概览
简要总结
The objective of this study is to evaluate the a molecular, OTC/At-Home COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the at-home molecular COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the sponsor (e.g., AN [anterior nares] swab) to determine accuracy of the at-home/OTC molecular COVID-19 Test in detecting COVID-19 in participants.
详细描述
The molevular, at-home COVID-19 Test is a unique rapid molecular test system intended to detect SARS-CoV-2 virus in the OTC setting using a dedicated reusable test reader to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the molecular COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The COVID-19 Test will leverage the processing and testing of the associated Swab device when inserted directly into the reaction tube (Key) where reverse transcription, Loop-Mediated Isothermal DNA Amplifications (LAMP) processing and sequence-specific probe technologies to detect segments of the SARS-CoV-2 genome are managed automatically by the reusable test reader.
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
- 是
入选标准
- •All Participants must meet ALL of the following:
- •≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent.
- •Able to read and write in English and/or Spanish (subjects or guardians)
- •Willing and able to provide informed consent (subject or Legally authorized Representative (LAR)). Subjects unable to consent will provide assent in addition to LAR consent.
- •Symptomatic Participants must meet BOTH of the following:
- •Have at least one of the following symptoms the day of the test:
- •Shortness of Breath
- •Difficulty Breathing
- •Muscle Pain
- •Sore Throat
- •New loss of taste or smell
- •Onset of symptoms occurred within the past 7 calendar days.
- •Asymptomatic Participants must meet BOTH of the following:
- •Not experiencing any of the following symptoms at the time of specimen collection and testing: fever, cough, shortness of breath or difficulty breathing, new loss of taste or smell, muscle or body aches, headache, sore throat, congestion or runny nose, nausea or vomiting or diarrhea.
- •Exposed to known COVID-19 positive individuals or are suspected to have had COVID-19 over the past 7 calendar days.
排除标准
- •Participants must not meet ANY of the following:
- •Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection.
- •Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months.
- •Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start.
- •Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy.
- •Previously participated in this study.
结局指标
主要结局
Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample.
时间窗: 1-16 weeks
The primary endpoints of this study will be the correlation of the 3EO Health SARS-CoV-2 OTC At Home Test results from nasal samples to the comparator, standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample
次要结局
未报告次要终点