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

Stopped early · Not applicable

Conditions studied: COVID-19

In brief

The purpose of this study is to evaluate the accuracy of the CareSuperb™ COVID-19 Antigen Home Test (sensitivity and specificity) in a simulated home use environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.

Key facts

Study ID

NCT05771714

Run by

AccessBio, Inc.

People needed

786

Starts

2023-01-09

Expected to finish

2023-05-11

Last updated by the study team

2023-07-13

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• L&A Morales Healthcare, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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