Back to resultsStudy Utilizing BIOZEK COVID-19 Antigen Rapid Test.
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BIOZEK COVID-19 Antigen Rapid Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
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.
- 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
Sites / Locations
- Mobile Covid Services LLC
Outcomes
Primary Outcome Measures
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
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.
Secondary Outcome Measures
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04805892
Brief Title
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
BIOZEK COVID-19 Antigen Rapid Test
Intervention Description
The BIOZEK COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals who are suspected of having COVID-19.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.
Description
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.
Time Frame
1 visit, up to 2 hours
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.
Description
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.
Time Frame
1 visit, up to 2 hours
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.
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
Facility Information:
Facility Name
Mobile Covid Services LLC
City
Flushing
State/Province
New York
ZIP/Postal Code
11354
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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