CareSuperb COVID-19 Antigen Test Usability

Sponsor
AccessBio, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05629455
Collaborator
(none)
30
1
2
28
32.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: CareSuperb COVID-19 Antigen Home Test Kit
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
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).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).
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
CareSuperb COVID-19 Antigen Home Test Usability Study
Actual Study Start Date :
Nov 17, 2022
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Usability of Quick Reference Instruction [One month]

    Primary Endpoints: 1. Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.

  2. Usability of Test Kit [One month]

    Primary Endpoints: 2. Assess the usability of the kit for home use based upon subject evaluation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 L&A Morales Healthcare Inc. Miami Florida United States 33142

Sponsors and Collaborators

  • AccessBio, Inc.

Investigators

  • Principal Investigator: Enrique Villa, MD, L&A Morales Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AccessBio, Inc.
ClinicalTrials.gov Identifier:
NCT05629455
Other Study ID Numbers:
  • AB-1001
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022