Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

Not Applicable

Completed

• Conditions: Covid-19 Testing

• Registration Number: NCT04926779
• Lead Sponsor: Mach-E B.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-15
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-04
• Results First Submitted: 2023-11-04
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Results First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.
  • 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.

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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)	6 months	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.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)	6 months	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.

Trial Locations

Locations (2)

Mobile Covid Services LLC; 🇺🇸 Flushing, New York, United States

Quality Research and Invention LLC; 🇺🇸 Southampton, New York, United States