CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 185 enrolled
Drug / intervention
Biozek Covid-19 Antigen Rapid Test (Saliva)other
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/NCT04926779
NCT04926779N/ACompleted
CompareCT.gov

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

Mach-E B.V.·interventional·Posted Jun 15, 2021·Updated Dec 20, 2023

In Brief

A clinical study evaluating Biozek Covid-19 Antigen Rapid Test (Saliva) for Covid-19 Testing. Completed, enrolled 185 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid-19 Testing
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 15, 2021
Enrollment StartMay 24, 2021
Primary CompletionNov 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.0 years ago

Interventions

Biozek Covid-19 Antigen Rapid Test (Saliva)other

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.