Trials / Completed

CompletedNCT04805892

Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 84 (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 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.

Conditions

Covid19

Interventions

Type	Name	Description
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.

Timeline

Start date: 2021-03-17
Primary completion: 2022-02-23
Completion: 2022-02-23
First posted: 2021-03-18
Last updated: 2023-06-29
Results posted: 2023-06-29

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04805892. Inclusion in this directory is not an endorsement.