Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

MACH-E

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: BIOZEK COVID-19 Antigen Rapid Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT04805892

#Biozek-ARTC-US

Details and patient eligibility

About

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.

Enrollment: 84 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.
• 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.
• Have a deviated nasal septum.
• Cognitively impaired individuals resulting in the inability to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)