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

Trial Summary

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

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.

Research Team

Enrique Villa, MD

Principal Investigator

L&A Morales Healthcare

Eligibility Criteria

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

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

Treatment Details

Interventions

• CareSuperb COVID-19 Antigen Home Test Kit

Participant Groups

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+

Findings from Research

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]

References

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]