Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

• Sponsor: Mach-E B.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04805892
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Actual Duration (Months): 11.3
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Diagnostic Test: BIOZEK COVID-19 Antigen Rapid Test	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Actual Study Start Date: Mar 17, 2021
• Actual Primary Completion Date: Feb 23, 2022
• Actual Study Completion Date: Feb 23, 2022

Outcome Measures

Primary Outcome Measures

1. Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a sample collected by healthcare professionals. [1 Month]

Secondary Outcome Measures

1. Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on self-collected sample. [1 Month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mobile Covid Services LLC	Flushing	New York	United States	11354

Sponsors and Collaborators

• Mach-E B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mach-E B.V.
• ClinicalTrials.gov Identifier: NCT04805892
• Other Study ID Numbers: #Biozek-ARTC-US
• First Posted: Mar 18, 2021
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Apr 29, 2022