Status:
COMPLETED
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.
Lead Sponsor:
Mach-E B.V.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 anal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04805892
Start Date
March 17 2021
End Date
February 23 2022
Last Update
June 29 2023
Active Locations (1)
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1
Mobile Covid Services LLC
Flushing, New York, United States, 11354