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OpenTrials
Completed

NCT Number: NCT04805892

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 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections 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, 11354, 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.
  • 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

Treatment and study plan

BIOZEK COVID-19 Antigen Rapid Test

Diagnostic Test

The BIOZEK COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals who are suspected of having COVID-19.

Primary outcomes

  1. Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals.

    Time frame: 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 outcomes

  1. Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples.

    Time frame: 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.

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 as Compared to Standard Testing Technique. Test Performed by a Professional Versus Self-collection and Standard of Care

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Jun 29, 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.

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