CareSuperb COVID-19 Antigen Test Usability

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Device: CareSuperb COVID-19 Antigen Home Test Kit

• Registration Number: NCT05629455
• Lead Sponsor: AccessBio, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-11-17
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-18
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-22
• Study First Posted: 2022-11-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
individuals ages 14 years and older	CareSuperb COVID-19 Antigen Home Test Kit	This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
individuals aged 2 to 13 years	CareSuperb COVID-19 Antigen Home Test Kit	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.

Primary Outcome Measures

Name	Time	Method
Usability of Quick Reference Instruction	One month	Primary Endpoints: 1. Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
Usability of Test Kit	One month	Primary Endpoints: 2. Assess the usability of the kit for home use based upon subject evaluation.

Trial Locations

Locations (1)

L&A Morales Healthcare Inc.; 🇺🇸 Miami, Florida, United States