NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronavirus
- COVID-19
- Sars Cov 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 2 years and 125 years
- Gender
- Both males and females
Description
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 qualitat...
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.
Tracking Information
- NCT #
- NCT04799392
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Beth Cobb NOW Diagnostics, Inc.
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