Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test

Launched by ACCESSBIO, INC. · Mar 14, 2023

Keywords

ClinConnect Summary

This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.

Patients presenting to the study site for COVID-19 testing who have signed the informed consent and assent, if applicable, and who meet the eligibility criteria will be enrolled in the study. Upon enrollment, the subject will be assigned a unique subject identification (ID) number...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. An Institutional Review Board (IRB) approved informed consent and assent (if applicable) is signed and dated prior to any study related activities.
• • 2. 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.
• • 3. 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.)
• • 4. Subject is willing to have nasal swabs collected by a member of the study staff.
• • 5. Subject agrees to complete all aspects of the study.
• Exclusion Criteria:
• • 1. 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.
• • 2. Subject is receiving convalescent plasma therapy for SARS-CoV-2.
• • 3. Subject used a nasal wash or nasal aspirate treatment on enrollment day.
• • 4. 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.
• • 5. Subjects who report or whose clinical status or history indicates that they take biotin \>10 mg per day.
• • 6. Subjects who previously enrolled in this study.
• • 7. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
• • 8. Subject has prior medical or laboratory training.
• • 9. Subject has prior knowledge of their current COVID-19 infection status.
• • 10. Subject with a history of frequent or difficult to control nosebleeds within the last fourteen (14) days.
• • 11. Subject has received a positive COVID-19 test result within the past sixty (60) days.