NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
Stopped early · Not applicable
Conditions studied: COVID-19, SARS-CoV-2, Coronavirus
In brief
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.
Key facts
- Study ID
- NCT04799392
- Run by
- NOWDiagnostics, Inc.
- People needed
- 50
- Starts
- 2021-04-01
- Expected to finish
- 2021-10-28
- Last updated by the study team
- 2021-11-05
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical Arts Pharmacy — Fayetteville, Arkansas, United States
- Goodrich Pharmacy — Anoka, Minnesota, United States
- Alps Specialty Pharmacy — Nixa, Missouri, United States
- Alps Pharmacy — Springfield, Missouri, United States
- Bremo Pharmacy — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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