Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

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.

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