The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended toÂ
detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimenÂ
from symptomatic individuals who are suspected of being infected with COVID-19 withinÂ
the first 7 days of symptom onset.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen isÂ
generally detectable in upper respiratory specimens during the acute phase of infection.Â
Positive results indicate the presence of viral antigens, but clinical correlation with patientÂ
history and other diagnostic information is necessary to determine infection status.Â
Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positiveÂ
should self-isolate and seek additional care from their healthcare provider. Positive resultsÂ
do not rule out bacterial infection or co-infection with other viruses. Negative results do notÂ
preclude SARS-CoV-2 infection. Individuals who test negative and continue to experienceÂ
COVID-like symptoms should seek follow up care from their healthcare provider.Â
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended to be used by laypersonsÂ
as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).