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

Sponsored by NOWDiagnostics, Inc.

About this trial

Last updated 4 years ago

Study ID

NOWDx COVID-19 Antibody OTC

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
2+ Years
All
All

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- 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

Locations

Location

Status