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Purpose

The purpose of this study is to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test in Home Use.

Condition

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study-related activities. 2. Male and female subjects 2 years of age and older. 3. Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay-user will collect the sample.) 4. Subject agrees to complete all aspects of the study.

Exclusion Criteria

  1. Subject has a visual impairment that cannot be restored with glasses or contact lenses. 2. Subject has prior medical or laboratory training. 3. Subject uses home diagnostics, e.g., glucose meters, HIV tests. 4. Subject has prior knowledge of their current COVID-19 infection status.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is an open label study to evaluate the usability of the CareSuperb COVID-19 Antigen Home Test using information from the Quick Reference Instructions (QRI).
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
individuals ages 14 years and older 		This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
  • Device: CareSuperb COVID-19 Antigen Home Test Kit
    At home COVID-19 antigen test kit
Experimental
individuals aged 2 to 13 years 		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.
  • Device: CareSuperb COVID-19 Antigen Home Test Kit
    At home COVID-19 antigen test kit

Recruiting Locations

More Details

NCT ID
NCT05629455
Status
Completed
Sponsor
AccessBio, Inc.

Detailed Description

COVID-19 is a contagious respiratory illness, caused by infection with the novel coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This communicable disease is easily transmitted through aerosolized droplets containing the infectious virus. Infections with SARS-CoV-2 can have varying degrees of signs and symptoms, ranging from asymptomatic to severe. Individuals infected with SARS-CoV-2 are believed to be contagious from as early as two days prior to symptom onset to at least ten days after the onset of symptoms. The rapid detection of infections and contacts and the implementation of infection control measures are critical for mitigation of this virus. The CareSuperb COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user-collected anterior nares swab samples from individuals aged 2 to 13 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.