Study Utilizing BIOZEK COVID-19 Antigen Rapid Test

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2022-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Covid-19 Testing

Keywords

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Covid-19 Antigen Rapid Test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Biozek Covid-19 Antigen Rapid Test (Saliva)

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mobile Covid Services LLC

Flushing, New York, United States

Site Status

Quality Research and Invention LLC

Southampton, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id