Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

NCT04926779 | Completed Results FDA Device

• 1 other identifier: Biozek-ARTC-US/002/4-12-2021
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Covid-19 Testing

Keywords

Covid-19; Antigen; Rapid; Test

Outcome Measures

Primary Outcomes (2)

• Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)

  The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula.

  6 months

• Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

  The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)\*100% formula. Specificity was calculated using (TN/TN+FP)\*100% formula.

  6 months

Interventions

Biozek Covid-19 Antigen Rapid Test (Saliva) DIAGNOSTIC_TEST

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.

Also known as: Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

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.
• Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection 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.
• Cannot perform self-collection of an oral fluid sample with use of oral fluid collection 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 (2)

Mobile Covid Services LLC

Flushing, New York, 11354, United States

Location

Quality Research and Invention LLC

Southampton, New York, 11968, United States

Location

MeSH Terms

Conditions

COVID-19; Fasting

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; Feeding Behavior; Behavior

Results Point of Contact

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

jstega@optonline.net

6462718593

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: June 11, 2021
• First Posted: June 15, 2021
• Study Start: May 24, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)