NOWDx Test for the Detection of Antibodies to COVID-19
Purpose
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 whole blood (venous and fingerstick).
Conditions
- COVID-19
- SARS-CoV-2
- Coronavirus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Persons ≥18 years old; - Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report.
Exclusion Criteria
- Persons <18 years old; - Persons who have previously participated in a NOWDx study.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Persons tested with investigational device |
Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test |
|
Recruiting Locations
More Details
- NCT ID
- NCT04690413
- Status
- Completed
- Sponsor
- NOWDiagnostics, Inc.
Detailed 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 qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick). 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 venous whole blood (EDTA) and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests.