The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days. Symptoms include fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, runny nose, nausea or vomiting and diarrhea.
This test has not been reviewed by the FDA
Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.
This test is not for home-use or at-home specimen collection.