Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: BIOZEK COVID-19 Antigen Rapid Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: BIOZEK COVID-19 Antigen Rapid Test|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 visit, up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 visit, up to 2 hours |