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 Type
OBSERVATIONAL
Enrollment
200
SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Professional collection of a second swab sample, for confirmation by PCR
Maria Sklodowska-Curie Medical Academy
Warsaw, Poland
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit
Sensitivity of SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
Time frame: 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)
Time frame: within 1 day
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