CareSuperb COVID-19 Antigen Test Usability

Overseen By Hanmaru Chon

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: AccessBio, Inc.

Disqualifiers: Visual impairment, Medical training, Home diagnostics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the CareSuperb COVID-19 Antigen Home Test, a home kit for detecting COVID-19. It is designed for people aged 14 and older to use themselves, and for adults to test children aged 2 to 13. The test works by identifying a virus protein using a nasal swab.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the CareSuperb COVID-19 Antigen Home Test Kit differ from other COVID-19 treatments?

The CareSuperb COVID-19 Antigen Home Test Kit is unique because it allows for self-administered, at-home testing without the need for lab equipment, making it a convenient and low-cost option for rapid COVID-19 detection. This differs from standard PCR tests that require lab processing and professional administration. ^{1 2 3 4 5}

What data supports the effectiveness of the CareSuperb COVID-19 Antigen Home Test Kit treatment?

The research suggests that home antigen tests, like the CareSuperb COVID-19 Antigen Home Test Kit, are useful for large-scale screening, especially for mild or asymptomatic COVID-19 cases, as they are easy to use and conserve healthcare resources. However, their effectiveness may be lower than lab-based tests due to potential user error. ^{2 5 6 7 8}

Who Is on the Research Team?

Enrique Villa, MD

Principal Investigator

L&A Morales Healthcare

Are You a Good Fit for This Trial?

Inclusion Criteria

Male and female subjects 2 years of age and older.

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.)

Subject agrees to complete all aspects of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Usability Testing

Participants use the CareSuperb COVID-19 Antigen Home Test to evaluate its usability

4 weeks

Home use

Follow-up

Participants are monitored for feedback on the usability of the test kit and instructions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CareSuperb COVID-19 Antigen Home Test Kit

How Is the Trial Designed?

Group I: individuals ages 14 years and older Experimental Treatment 1 Intervention

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 II: individuals aged 2 to 13 years Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AccessBio, Inc.

Lead Sponsor

Trials

2

Recruited

820+

Published Research Related to This Trial

Self-collection kits for COVID-19 testing, like those approved by the FDA from LapCorp and Everlywell, offer a convenient and effective screening method for mild or asymptomatic patients, helping to alleviate the burden on healthcare systems.

While these home-based kits are user-friendly and conserve resources, their efficacy can be impacted by issues such as improper sampling techniques and lack of clinical oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Sample Self-Collection for COVID-19 Patients. Liao, WT., Hsu, MY., Shen, CF., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Home Sample Self-Collection for COVID-19 Patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Performance and Operational Evaluation of the Access Bio CareStart Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of large-scale population testing for SARS-CoV-2 detection by self-testing at home. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A lyophilized colorimetric RT-LAMP test kit for rapid, low-cost, at-home molecular testing of SARS-CoV-2 and other pathogens. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Rapid antigen test had up to 98% sensitivity and 100% specificity for detecting COVID-19 in persons with mild symptoms. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Self-testing for the detection of SARS-CoV-2 infection with rapid antigen tests for people with suspected COVID-19 in the community. [2022]