Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

June 11, 2023 updated by: Mach-E B.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Flushing, New York, United States, 11354
        • Mobile Covid Services LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
Time Frame: 1 visit, up to 2 hours

The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)*100% formula.

Specificity was calculated using (TN/TN+FP)*100% formula.
1 visit, up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.
Time Frame: 1 visit, up to 2 hours

The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)*100% formula.

Specificity was calculated using (TN/TN+FP)*100% formula.
1 visit, up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mach-E B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

February 23, 2022

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #Biozek-ARTC-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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