Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

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

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.

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