SARS-CoV-2 Antigen Rapid Test (Self- Testing)
SARS-CoV-2 Antigen Rapid Test is a lateral chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal or nasopharyngeal swab speciments directly from individuals who are suspected of COVID-19 by theire healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test can also test specimens from asymptomatic individuals.
This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years older. The Antigen Home Test does not require serial testing.
Clinical Performance
Nasal Swab Specimens
The performance of SARS-CoV-2 Antigen Rapid Test was established with 605 nasal swabs collected from individual symptomatic patients who were suspected of COVID-19. The results show that the relative sensitivity and the relative specificity are as follows:
Materials Provided