NCT04926779

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Mach-E B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid-19 Testing

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-24
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2021-06-15
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study