Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test
COVID-19
About this trial
This is an interventional diagnostic trial for COVID-19 focused on measuring SARS-CoV-2, COVID-19, Home Test
Eligibility Criteria
Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent and assent (if applicable) is signed and dated prior to any study related activities. Male and female subjects 2 years of age and older, presenting to the site seeking COVID-19 testing. If symptomatic, symptom onset must be within 5 days of enrollment into the study. Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult lay user.) Subject is willing to have nasal swabs collected by a member of the study staff. Subject agrees to complete all aspects of the study. Exclusion Criteria: Subject is undergoing treatment currently and/or within the past 30 days of study enrollment with medication to treat SARS-CoV-2, which may include but is not limited to Paxlovid, Remdesivir. Subject is receiving convalescent plasma therapy for SARS-CoV-2. Subject used a nasal wash or nasal aspirate treatment on enrollment day. Subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic treatment or therapy, or drug. Subjects who report or whose clinical status or history indicates that they take biotin >10 mg per day. Subjects who previously enrolled in this study. Subject has a visual impairment that cannot be restored with glasses or contact lenses. Subject has prior medical or laboratory training. Subject has prior knowledge of their current COVID-19 infection status. Subject with a history of frequent or difficult to control nosebleeds within the last fourteen (14) days. Subject has received a positive COVID-19 test result within the past sixty (60) days.
Sites / Locations
- L&A Morales Healthcare, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
individuals ages 14 years and older
individuals aged 2 to 13 years
This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample.