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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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. - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Recruiting Locations

More Details

NCT ID
NCT04926779
Status
Completed
Sponsor
Mach-E B.V.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.