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Study Utilizing BIOZEK COVID-19 Antigen Rapid Test. | Clinical Trials | Clareo Health

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Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care

NCT04805892•Mach-E B.V.

View on ClinicalTrials.gov

Summary

This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
•Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
•Currently experiencing symptoms of COVID-19.
•Be clinically diagnosed or suspected to have COVID-19.
•Recent past (3 weeks) exhibited symptoms of COVID-19.
•Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
•Interacted with a COVID-19 positive individual.

Exclusion Criteria

•Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
•Have a deviated nasal septum.
•Cognitively impaired individuals resulting in the inability to provide informed consent

Locations (1)

Mobile Covid Services LLC

Flushing, New York, United States

Key Dates

Start Date

March 17, 2021

Primary Completion Date

February 23, 2022

Completion Date

February 23, 2022

Last Updated

June 29, 2023

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

BIOZEK COVID-19 Antigen Rapid Test

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Inclusion Criteria

Exclusion Criteria

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