A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit As Compared To The Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay Among Asymptomatic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- COVID-19 Prevalence Rate / Expected Values percentages
研究概览
简要总结
To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.
详细描述
This Lucira COVID-19 All-In-One Test Kit recently received FDA Emergency Use Authorization (EUA) for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. The basis for this FDA EUA authorization was Lucira Health's first Community Testing study (07A-CLI-006) conducted among individuals suspected of COVID-19. This follow on performance study will be used to establish the performance of the Lucira COVID-19 All-In-One Test Kit as compared to a known high sensitivity RT-PCR molecular assay among asymptomatic individuals. The results of this study will be used to support an expanded indication for the Lucira COVID-19 All-In-One Test Kit among asymptomatic individuals.
This performance study will include the collection of subject demographics and nasal swabs self-collected by study subjects at community-based locations with trained medical staff oversight.
After determining subject eligibility and following the completion of the informed consent process, each subject will receive a unique study identification number.
A subject's participation in this study will consist of one study visit with one collection event. The subject self-collects a nasal swab sample and runs the Lucira COVID-19 All-In-One Test Kit according to the FDA EUA authorized package insert instructions.
Subject will be observed during the swabbing collection by the study staff and study staff will document collection details and any collection issues. Nasal swabs obtained from self-collection will be discarded after having been used for testing per the instructions. Study staff will interpret and share the Lucira COVID-19 All-In-One Test Kit result with study subjects.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to read and write in English
- •Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils
排除标准
- •Currently suffering from nasal trauma such as a nosebleed
- •Received a nasal rinse/wash/aspirates in past 12 hours
- •Currently experiencing any of the CDC COVID-19 symptoms:
- •Shortness of breath or difficulty breathing
- •New loss of taste or smell
- •Muscle or body aches
- •Sore throat
- •Congestion or runny nose
- •Nausea or vomiting
研究组 & 干预措施
Subject Self-Collection and Specimen Testing
Subjects will be provided with the Lucira COVID-19 Test Kit and collect one (1) nasal swab according to the QRI and test the sample on the Lucira COVID-19 All-In-One Test. HCP will observe subject during this process and document any observations and deviations from the QRI.
干预措施: Lucira COVID-19 All-In-One test kit (Device)
结局指标
主要结局
COVID-19 Prevalence Rate / Expected Values percentages
时间窗: 3 Months
Study prevalence of SARS-CoV-2 will be summarized by percentages and grouped by age
COVID-19 Prevalence Rate / Expected Values counts
时间窗: 3 months
Study prevalence of SARS-CoV-2 will be summarized by counts and grouped by age
次要结局
- Collection Performance/ Incidence Rate percentages(3 Months)
- Collection Performance/ Incidence Rate counts(3 Months)
- Sensitivity and specificity(3 Months)