Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805892
• Other study ID #: #Biozek-ARTC-US
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: April 2022
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 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.

• 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.

• Have a deviated nasal septum.

• Cognitively impaired individuals resulting in the inability to provide informed consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
United States	Mobile Covid Services LLC	Flushing	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 on a Sample Collected by Healthcare Professionals.	The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)*100% formula.; Specificity was calculated using (TN/TN+FP)*100% formula.	1 visit, up to 2 hours
Secondary	Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.	The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)*100% formula.; Specificity was calculated using (TN/TN+FP)*100% formula.	1 visit, up to 2 hours