Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

NCT04805892 | Completed Results DMC FDA Device

• 1 other identifier: #Biozek-ARTC-US
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.

  1 visit, up to 2 hours

Interventions

BIOZEK COVID-19 Antigen Rapid Test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mach-E B.V.: lead

Study Sites (1)

Mobile Covid Services LLC

Flushing, New York, 11354, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Zanetta Malanowska-Stega
• Organization: Quality Research and Invention LLC

jstega@optonline.net

6464001204

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: March 17, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 29, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)