SETCOV: COVID-19 Antigen Rapid Test Kit

Sponsor

Polish Society of Disaster Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04889365

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

101.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection	Diagnostic Test: SG Diagnostics COVID-19 Antigen Rapid Test Kit Diagnostic Test: Polymerase chain reaction (PCR) test

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 11, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jul 10, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit [within 1 day]
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit [within 1 day]
Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult (aged ≥ 18 years) volunteers

Exclusion Criteria:

Children (aged < 18years)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maria Sklodowska-Curie Medical Academy	Warsaw		Poland	03-411

Sponsors and Collaborators

Polish Society of Disaster Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Polish Society of Disaster Medicine

ClinicalTrials.gov Identifier:

NCT04889365

Other Study ID Numbers:

PTMK_2021_01

First Posted:

May 17, 2021

Last Update Posted:

May 17, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Polish Society of Disaster Medicine

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 17, 2021