Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

Completed · Not applicable

Conditions studied: Covid-19 Testing

In brief

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.

Key facts

Study ID

NCT04926779

Run by

Mach-E B.V.

People needed

185

Starts

2021-05-24

Expected to finish

2022-11-04

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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…

• 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

Where it is running

• Mobile Covid Services LLC — Flushing, New York, United States
• Quality Research and Invention LLC — Southampton, New York, United States

Full record on ClinicalTrials.gov

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