Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

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.

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Key information

Conditions

COVID-19 Testing Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Fasting Feeding Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mobile Covid Services LLC, Flushing, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biozek Covid-19 Antigen Rapid Test (Saliva)

Diagnostic Test

Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.

Other names: Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

Primary outcomes

Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mach-E B.V.

Industry

Registry information

Official study title

Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 15, 2021
Registry last updated: Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed