COVID-19 Antigen Rapid Test Kit (SETCOV)

May 13, 2021 updated by: Polish Society of Disaster Medicine

The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2

The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 03-411
        • Maria Sklodowska-Curie Medical Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Volunteers with or without COVID-19 symptoms

Description

Inclusion Criteria:

  • Adult (aged ≥ 18 years) volunteers

Exclusion Criteria:

  • Children (aged < 18years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 positive, asymptomatic
COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)
Diagnostic test: SG Diagnostics COVID-19 Antigen Rapid Test Kit
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Diagnostic test: Polymerase chain reaction (PCR) test
Professional collection of a second swab sample, for confirmation by PCR
COVID-19 positive, symptomatic
COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)
Diagnostic test: SG Diagnostics COVID-19 Antigen Rapid Test Kit
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Diagnostic test: Polymerase chain reaction (PCR) test
Professional collection of a second swab sample, for confirmation by PCR
COVID-19 negative
COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)
Diagnostic test: SG Diagnostics COVID-19 Antigen Rapid Test Kit
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Diagnostic test: Polymerase chain reaction (PCR) test
Professional collection of a second swab sample, for confirmation by PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Time Frame: within 1 day
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
within 1 day
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Time Frame: within 1 day
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
within 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polish Society of Disaster Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2021

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

July 10, 2021

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTMK_2021_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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