CareSuperb Antigen Test for Coronavirus

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the ease of using the CareSuperb COVID-19 Antigen Home Test Kit at home. The goal is to determine if individuals can effectively collect a nasal sample and obtain results independently. Participants should be comfortable taking a nasal swab themselves; however, for children aged 2 to 13, an adult will assist with the swab. Suitable candidates should not have prior experience with home medical tests or knowledge of their current COVID-19 status. As an unphased trial, this study provides an opportunity to contribute to important research on home testing accessibility.

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 prior data suggests that the CareSuperb COVID-19 Antigen Home Test Kit is safe for home use?

Research has shown that the CareSuperb COVID-19 Antigen Home Test is safe to use. The FDA has determined that this test matches other tests in safety. It quickly detects the COVID-19 virus and is easy to use at home.

Safety data indicates no significant risks with the test. If the liquid from the test's vial contacts the skin, it might cause slight irritation, but this is not a major concern. Swallowing the liquid is not known to be harmful, and inhaling it poses no problem.

Overall, the test is safe and easy to use at home for anyone 14 years and older. An adult can collect samples for younger children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CareSuperb COVID-19 Antigen Home Test Kit because it offers an easy, non-prescription option for home testing, making it accessible for a wide range of users. Unlike traditional tests that require a visit to a healthcare facility, this test can be self-administered using a simple nasal swab. The kit is designed for both teens and adults to use independently, while children aged 2 to 13 can be tested by an adult, broadening its applicability to families. This convenience and flexibility could lead to faster diagnosis and management of COVID-19, helping to curb the spread of the virus in communities.

What evidence suggests that the CareSuperb COVID-19 Antigen Home Test Kit is effective for home use?

Research has shown that the CareSuperb COVID-19 Antigen Home Test reliably detects the virus that causes COVID-19. This trial will assess the test's effectiveness across different age groups. Studies have found that the test quickly identifies the virus, with a sensitivity rate of 50.0% to 85.7%, indicating it can correctly detect the virus in many cases. Its specificity ranges from 89.5% to 99.1%, demonstrating its accuracy in identifying individuals without the virus. This suggests the test is effective for checking COVID-19 status at home. ^{1 2 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. clinicaltrials.gov clinicaltrials.gov/study/NCT05771714

Clinical Performance Evaluation of the CareSuperb ... 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 ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K241915.pdf

January 29, 2025 Access Bio, Inc. Sung Jang Senior Manager ... The CareSuperb COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/K241915.pdf

A 510(k) Number K241915 B Applicant Acce The CareSuperb COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8244626/

Performance and Operational Evaluation of the Access Bio ... We evaluated the CareStart COVID-19 Antigen test in a high-throughput community testing site. We observed 50.0%–85.7% sensitivity and 89.5%–99.1% specificity ...

5. withpower.com withpower.com/trial/phase-covid-19-10-2022-3943b

CareSuperb COVID-19 Antigen Test Usability 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 ...

6. s878047141.onlinehome.us s878047141.onlinehome.us/wp-content/uploads/2021/09/MSDS16-RCH-B-C19-Ag-2021-04-13F.pdf

Material Safety Data Sheet – CareStartTM COVID-19 Antigen Skin Contact: Irritation. ▫ Ingestion: No known significant effect or critical hazard upon ingestion of extraction vial in the kit. ▫ Inhalation ...

7. accessbio.net accessbio.net/products/covid-19-detection-kits/carestart-covid-19-antigen

CareStart™ COVID-19 Antigen CareStart™ COVID-19 Antigen Home Test · CareStart™ COVID-19 Antigen · CareStart ... MATERIAL SAFETY DATA SHEET (MSDS). CONTACT US. CONTACT US FOR. MORE ...

8. germainelabs.com germainelabs.com/wp-content/uploads/2021/11/Flowflex-Covid-19-Antigen-Home-Test-Safety-Data-Sheet-1.pdf?srsltid=AfmBOopU4RLE4NJ4GuzPO_3lEET83xeNstY1ob0BfqEj34xHOh07GnIb

Safety Data Sheet – Flowflex COVID-19 Antigen Home Test The test is not classified as hazardous. For skin contact, wash with water. Ensure good ventilation, wear gloves and safety glasses. Restricted to users 14+.