NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator
研究概览
简要总结
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
详细描述
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.
The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing of human fingerstick whole blood is intended to be conducted in a home-like setting of a facility authorized to perform CLIA waived tests.
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
- •Innate Infection Cohort>
- •PCR positives: persons who were symptomatic for COVID-19 and have tested positive for COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test
- •PCR negatives: persons who have never had COVID-19 and who have tested negative for COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test
- •persons 2+ years old
- •Vaccination Cohort>
- •persons 7- 60 days post second dose of EUA COVID-19 vaccine
- •persons 18+ years old
- •Exclusion criteria:
- •Innate Infection Cohort>
- •PCR positives: persons with a COVID-19 positive test result >45 days old
- •PCR negatives: persons with any prior COVID-19 positive result
- •persons who have received COVID-19 vaccine
- •persons <2 years old
- •Vaccination Cohort>
- •persons symptomatic or previously infected with COVID-19 prior to vaccination
- •persons <18 years old
排除标准
- 未提供
结局指标
主要结局
Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator
时间窗: through study completion; an average of 2 months
Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR test.
Positivity rate of NOWDx COVID-19 Tests in vaccinated persons
时间窗: through study completion; an average of 2 months
Calculate positivity rate of NOWDx COVID-19 Tests in persons post emergency use authorized or FDA cleared COVID-19 vaccination.
次要结局
未报告次要终点