CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
BIOZEK COVID-19 Antigen Rapid Testother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04805892
NCT04805892N/ACompleted

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

Mach-E B.V.·interventional·Posted Mar 18, 2021·Updated Jun 29, 2023

In Brief

A clinical study evaluating BIOZEK COVID-19 Antigen Rapid Test for Covid19. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 18, 2021
Enrollment StartMar 17, 2021
Primary CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.3 years ago

Interventions

BIOZEK COVID-19 Antigen Rapid Testother

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.