Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 786
- 试验地点
- 2
- 主要终点
- Positive percent agreement with sensitivity
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.
详细描述
This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.
Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent, if applicable, and who meet the eligibility criteria will be enrolled in the study. Upon enrollment, the subject will be assigned a unique subject identification (ID) number. After obtaining relevant demographic and medical information, testing will ensue.
The first sample, collected by the clinical research staff, will be for the standard of care (SOC). Results of the SOC test will be used for subject treatment and management. To mitigate any potential bias which may affect the subject's visual interpretation of the CareSuperb™ test result, the study staff will not provide the SOC test results to the subject until after the results of the CareSuperb™ test are read by the subject.
There will be a 15-minute minimum wait period prior to the collection of the second anterior nares swab sample and an additional 15-minute minimum wait period between the second and third sample collection.
For Even numbered subjects, the second sample, collected by a study staff member, will be used for the RT-PCR comparator tests. The third sample will be collected and tested by the lay user, using the CareSuperb™ COVID-19 Antigen Home Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •An Institutional Review Board (IRB) approved informed consent and assent (if applicable) is signed and dated prior to any study related activities.
- •Male and female subjects 2 years of age and older, presenting to the site seeking COVID-19 testing. If symptomatic, symptom onset must be within 5 days of enrollment into the study.
- •Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult lay user.)
- •Subject is willing to have nasal swabs collected by a member of the study staff.
- •Subject agrees to complete all aspects of the study.
排除标准
- •Subject is undergoing treatment currently and/or within the past 30 days of study enrollment with medication to treat SARS-CoV-2, which may include but is not limited to Paxlovid, Remdesivir.
- •Subject is receiving convalescent plasma therapy for SARS-CoV-
- •Subject used a nasal wash or nasal aspirate treatment on enrollment day.
- •Subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic treatment or therapy, or drug.
- •Subjects who report or whose clinical status or history indicates that they take biotin >10 mg per day.
- •Subjects who previously enrolled in this study.
- •Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- •Subject has prior medical or laboratory training.
- •Subject has prior knowledge of their current COVID-19 infection status.
- •Subject with a history of frequent or difficult to control nosebleeds within the last fourteen (14) days.
- •Subject has received a positive COVID-19 test result within the past sixty (60) days.
结局指标
主要结局
Positive percent agreement with sensitivity
时间窗: within two weeks of study enrollment
Compare the positive result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
Negative percent agreement with specificity
时间窗: within two weeks of study enrollment
Compare the negative result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.
次要结局
未报告次要终点