CareSuperb COVID-19 Antigen Test Usability

NCT ID: NCT05629455

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2022-11-22

Brief Summary

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

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.

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CareSuperb COVID-19 Antigen Home Test Kit

Intervention Type: DEVICE

At home COVID-19 antigen test kit

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.

Group Type: EXPERIMENTAL

CareSuperb COVID-19 Antigen Home Test Kit

Intervention Type: DEVICE

At home COVID-19 antigen test kit

Interventions

CareSuperb COVID-19 Antigen Home Test Kit

At home COVID-19 antigen test kit

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AccessBio, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrique Villa, MD

Role: PRINCIPAL_INVESTIGATOR

L&A Morales Healthcare

Locations

L&A Morales Healthcare Inc.

Miami, Florida, United States

Countries

United States

Other Identifiers

AB-1001

Identifier Type: -

Identifier Source: org_study_id