Clinical Performance Evaluation of the CareSuperb™ COVID-19 Antigen Home Test

NCT05771714 | Terminated FDA Device

• 1 other identifier: CT-22255-PR
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 1

Brief Summary

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 environment when compared to the Roche cobas SARS-CoV-2 (EUA200009), Hologic Panther Fusion SARS-CoV-2 (EUA200014), and Roche cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (EUA210388) high sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assays.

Conditions

COVID-19

Keywords

SARS-CoV-2, COVID-19, Home Test

Outcome Measures

Primary Outcomes (2)

• Positive percent agreement with sensitivity

  Compare the positive result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.

  within two weeks of study enrollment

• Negative percent agreement with specificity

  Compare the negative result between CareSuperb COVID-19 Ag Home Test and three RT-PCR comparators.

  within two weeks of study enrollment

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 and assent (if applicable) is signed and dated prior to any study related activities.
• Male and female subjects 2 years of age and older, presenting to the site seeking COVID-19 testing. If symptomatic, symptom onset must be within 5 days of enrollment into the study.
• Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult lay user.)
• Subject is willing to have nasal swabs collected by a member of the study staff.
• Subject agrees to complete all aspects of the study.

You may not qualify if:

• Subject is undergoing treatment currently and/or within the past 30 days of study enrollment with medication to treat SARS-CoV-2, which may include but is not limited to Paxlovid, Remdesivir.
• Subject is receiving convalescent plasma therapy for SARS-CoV-2.
• Subject used a nasal wash or nasal aspirate treatment on enrollment day.
• Subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic treatment or therapy, or drug.
• Subjects who report or whose clinical status or history indicates that they take biotin \>10 mg per day.
• Subjects who previously enrolled in this study.
• Subject has a visual impairment that cannot be restored with glasses or contact lenses.
• Subject has prior medical or laboratory training.
• Subject has prior knowledge of their current COVID-19 infection status.
• Subject with a history of frequent or difficult to control nosebleeds within the last fourteen (14) days.
• Subject has received a positive COVID-19 test result within the past sixty (60) days.

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

• Hyeonsuk Kim

  Access Bio

  STUDY DIRECTOR

Study Design

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

Model Details: This is an open label, prospective, randomized clinical agreement study to evaluate the sensitivity and specificity of the CareSuperb™ COVID-19 Antigen Home Test when a lay person conducts the test on themselves, or another study participant, as compared to EUA authorized high sensitivity RT-PCR comparator tests.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 16, 2023
• Study Start: January 9, 2023
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

US (1)