COVID-19 Antigen Rapid Test Kit
SETCOV
The Use of SG Diagnostics COVID-19 Antigen Rapid Test Kit for Self-testing as a Method for Reduction SARS-CoV-2
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2021
CompletedMay 17, 2021
May 1, 2021
2 months
May 10, 2021
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
COVID-19 positive, asymptomatic
COVID-19 positive, asymptomatic (i.e. no current symptoms of COVID-19, confirmed PCR positive for COVID-19)
COVID-19 positive, symptomatic
COVID-19 positive, symptomatic (i.e. current symptoms of COVID-19, confirmed PCR positive for COVID-19)
COVID-19 negative
COVID-19 negative (i.e. no current or previous symptoms of COVID-19, confirmed PCR negative for COVID-19)
Interventions
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Professional collection of a second swab sample, for confirmation by PCR
Eligibility Criteria
Volunteers with or without COVID-19 symptoms
You may qualify if:
- Adult (aged ≥ 18 years) volunteers
You may not qualify if:
- Children (aged \< 18years)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Sklodowska-Curie Medical Academy
Warsaw, 03-411, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 17, 2021
Study Start
May 11, 2021
Primary Completion
June 30, 2021
Study Completion
July 10, 2021
Last Updated
May 17, 2021
Record last verified: 2021-05