Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

MACH-E

Status

Completed

Conditions

Covid-19 Testing

Treatments

Diagnostic Test: Biozek Covid-19 Antigen Rapid Test (Saliva)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04926779

Biozek-ARTC-US/002/4-12-2021

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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