CareSuperb COVID-19 Antigen Test Usability

NCT05629455 | Completed FDA Device

• 1 other identifier: AB-1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Usability of Quick Reference Instruction

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

  One month

• Usability of Test Kit

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

  One month

Study Arms (2)

individuals ages 14 years and older

EXPERIMENTAL

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

individuals aged 2 to 13 years

EXPERIMENTAL

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

Interventions

CareSuperb COVID-19 Antigen Home Test Kit DEVICE

At home COVID-19 antigen test kit

individuals aged 2 to 13 years; individuals ages 14 years and older

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study-related activities.
• 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.

You may not qualify if:

• Subject has a visual impairment that cannot be restored with glasses or contact lenses.
• Subject has prior medical or laboratory training.
• Subject uses home diagnostics, e.g., glucose meters, HIV tests.
• Subject has prior knowledge of their current COVID-19 infection status.

Sponsors & Collaborators

• AccessBio, Inc.: lead

Study Sites (1)

L&A Morales Healthcare Inc.

Miami, Florida, 33142, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Enrique Villa, MD

  L&A Morales Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: November 17, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)