Clinical Evaluation of The BD Veritor™ At-Home COVID-19 & Flu Test and BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,146
- 试验地点
- 13
- 主要终点
- Diagnostic accuracy of the BD Veritor At-Home Assay
研究概览
简要总结
The BD Veritor™ System is a rapid test that is testing for both COVID-19 and for Influenza This study will try to determine if the BD Veritor™ system can assist in the diagnosis of someone who has upper respiratory infection symptoms. There is both an At-Home self test and test completed by a health care professional that will be completed during this study.
详细描述
This is a prospective, multi-country, multicenter, comparative study to assess the performance of the BD Veritor™ At-Home SARS-CoV-2 & Flu A+B test and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B (Professional use) compared to an FDA approved Flu A/B reference assay (RT-PCR) and FDA authorized molecular SARS-CoV-2 comparator reference method assays.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants symptomatic of an acute respiratory illness within 7 DOSO
- •≥2 years of age at the time of study participation
- •Symptomatic subjects with
- •a. Any one of the following symptoms (with or without additional symptoms):
- •Oral/temporal artery: ≥100.4 °F / ≥38.0 °C
- •Rectal/Ear: ≥101.2 °F / ≥38.5 °C
- •ii. Cough
- •iii. Malaise (fatigue/extreme tiredness)
- •b. Or two of the following symptoms:
- •i. Sore throat,
- •ii. Shortness of breath/difficult breathing
- •iii. Rhinorrhea (runny or stuffy nose),
- •iv. Myalgia,
- •v. Headache,
- •vi. Sneezing,
- •vii. New loss of taste or smell,
- •viii. One or more GI symptoms (nausea, vomiting, diarrhea)
排除标准
- •Participants currently undergoing treatment and/or within the past thirty (30) days of the study, with medication to treat novel Coronavirus SARS-CoV-2 viral infections, which may include but is not limited to Remdesivir (Veklury)
- •Participants receiving convalescent plasma therapy for SARS-CoV-
- •Participants who have received antiviral medications for influenza within the previous 30 days.
- •Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit.
- •The participant is currently receiving or has received within the past thirty (30) days of the study visit, an experimental biologic or drug including either treatment or therapy.
- •Participants who have been previously enrolled in the study.
- •History of frequent or difficult to control nosebleeds within the last fourteen (14) days.
- •Participants who have tested positive for Flu A/B or SARS-CoV-2 within the last 28 days (excluding the day of enrollment in the study).
- •Exclusion criteria for the participation in the At-Home portion of the study would include all of the criteria previously listed and include the following
- •Participants without the ability to read or write in the English Language
- •Participants with prior medical or laboratory training.
结局指标
主要结局
Diagnostic accuracy of the BD Veritor At-Home Assay
时间窗: Immediately after specimen collection
Positive percent agreement of the BD Veritor At-Home Assay compared to an FDA cleared/approved RT-PCR Assay
Diagnostic accuracy of the BD Veritor Professional Assay
时间窗: Immediately after specimen collection
Positive percent agreement of the BD Professional Assay compared to an FDA cleared/approved RT-PCR Assay
次要结局
- Ease of Use of the BD Veritor At-Home Assay(Within 30 minutes of test completion)
- Ease of Use of the BD Professional Assay(Within 1 day of first device use)