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NCT04889365 Clinical Trial

COVID-19 Antigen Rapid Test Kit

SARS-CoV2 Infection Clinical Trial

— SETCOV  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04889365
Other study ID # PTMK_2021_01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 11, 2021
Est. completion date July 10, 2021

Study information
Verified date May 2021
Source Polish Society of Disaster Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date July 10, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (aged = 18 years) volunteers Exclusion Criteria: - Children (aged < 18years)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• SG Diagnostics COVID-19 Antigen Rapid Test Kit
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
• Polymerase chain reaction (PCR) test
Professional collection of a second swab sample, for confirmation by PCR

Locations
Country Name City State
Poland Maria Sklodowska-Curie Medical Academy Warsaw

Sponsors (1)
Lead Sponsor Collaborator
Polish Society of Disaster Medicine

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) within 1 day
Primary Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit Specificity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use) within 1 day
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