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 (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.

Official Title
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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

Conditions
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Covid-19 Testing

Intervention / Treatment
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* Diagnostic Test: Biozek Covid-19 Antigen Rapid Test (Saliva)


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. 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

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 (Saliva)|Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.|

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 (Saliva) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 6 months | 
| Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Antigen, Rapid, Test