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

NCT05771714 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 786

Last updated 2023-07-13

No results posted yet for this study

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

Interventions

DEVICE

CareSuperb COVID-19 Antigen Home Test Kit

At home COVID-19 antigen test kit

Sponsors & Collaborators

  • AccessBio, Inc.

    lead OTHER

Principal Investigators

  • Hyeonsuk Kim · Access Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2023-05-11
Completion
2023-05-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771714 on ClinicalTrials.gov