SARS-CoV2 Infection
Conditions
Keywords
SARS-CoV-2, COVID-19, symptoms, test
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.
Interventions
DIAGNOSTIC_TESTSG Diagnostics COVID-19 Antigen Rapid Test Kit
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
DIAGNOSTIC_TESTPolymerase chain reaction (PCR) test
Professional collection of a second swab sample, for confirmation by PCR
Sponsors
Polish Society of Disaster Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (aged ≥ 18 years) volunteers
Exclusion criteria
* Children (aged \< 18years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Poland
Outcome results
None listed