Back to resultsStudy Utilizing BIOZEK COVID-19 Antigen Rapid Test
Primary Purpose
Covid-19 Testing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biozek Covid-19 Antigen Rapid Test (Saliva)
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid-19 Testing focused on measuring Covid-19, Antigen, Rapid, Test
Eligibility Criteria
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.
- Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection 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.
- Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
- Have a deviated nasal septum.
- Cognitively impaired individuals resulting in the inability to provide informed consent
Sites / Locations
- Mobile Covid Services LLC
- Quality Research and Invention LLC
Outcomes
Primary Outcome Measures
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04926779
Brief Title
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
Official Title
Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mach-E B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Testing
Keywords
Covid-19, Antigen, Rapid, Test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Biozek Covid-19 Antigen Rapid Test (Saliva)
Other Intervention Name(s)
Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Intervention Description
Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
Time Frame
3 months
Title
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection 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.
Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
Have a deviated nasal septum.
Cognitively impaired individuals resulting in the inability to provide informed consent
Facility Information:
Facility Name
Mobile Covid Services LLC
City
Flushing
State/Province
New York
ZIP/Postal Code
11354
Country
United States
Facility Name
Quality Research and Invention LLC
City
Southampton
State/Province
New York
ZIP/Postal Code
11968
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
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