Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Not Applicable

Completed

Conditions: Covid19

Registration Number: NCT04805892

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

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 on a Sample Collected by Healthcare Professionals.	1 visit, up to 2 hours	The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)\100% formula. Specificity was calculated using (TN/TN+FP)\100% formula.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.	1 visit, up to 2 hours	The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)\100% formula. Specificity was calculated using (TN/TN+FP)\100% formula.