Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

Covid-19 Testing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926779
• Other study ID #: Biozek-ARTC-US/002/4-12-2021
• Status: Completed
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: November 4, 2022

Study information

• Verified date: December 2023
• Source: Mach-E B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid-19 Testing

Intervention

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.

Locations

Country	Name	City	State
United States	Mobile Covid Services LLC	Flushing	New York
United States	Quality Research and Invention LLC	Southampton	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mach-E B.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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