Coronavirus, COVID-19, SARS-CoV-2
Conditions
Brief summary
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
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.
Interventions
DEVICENOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.
Sponsors
NOWDiagnostics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator | 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 | 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. |
Countries
United States
Outcome results
None listed