NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

Conditions
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COVID-19, SARS-CoV-2, Coronavirus

Intervention / Treatment
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* Device: NOWDx COVID-19 Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persons tested with investigational device following PCR test<br>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 | Device: NOWDx COVID-19 Test<br>* The investigational device is the NOWDx COVID-19 Test.<br>|
| Experimental: Persons tested with investigational device following vaccination<br>Persons tested with investigational device who previously were vaccinated for COVID-19 with an emergency use authorized or FDA cleared COVID-19 vaccine | Device: NOWDx COVID-19 Test<br>* The investigational device is the NOWDx COVID-19 Test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator | 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. | through study completion; an average of 2 months | 
| Positivity rate of NOWDx COVID-19 Tests in vaccinated persons | Calculate positivity rate of NOWDx COVID-19 Tests in persons post emergency use authorized or FDA cleared COVID-19 vaccination. | through study completion; an average of 2 months |