Genabio COVID-19 Rapid Self-Test is easy to use and give you accurate rapid results in as few as 15 minutes in the comfort of your own home. This test is for over-the-counter (OTC) at home and other non-laboratory sites for patients 2 years or older who are suspected of COVID-19 by a healthcare provider within the first 7 days of symptom onset. This test is also for nonprescription or over-the-counter (OTC) at home and other non-laboratory sites for screening of individuals 2 years or older without symptoms or other reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours and no more than 48 hours between tests.
Directions: The Genabio COVID-19 Rapid Self-Test Kit is a rapid lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also intended for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The Genabio COVID-19 Rapid Self-Test Kit does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the Genabio COVID-19 Rapid Self-Test Kit should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
