Product Description
- Genabio COVID-19 Rapid Self Test is for use under an FDA Emergency Use Authorization only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- The Genabio COVID-19 Rapid Self-Test Kit is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus
- 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
- This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
- Positive results indicate the presence of viral antigens, but clinical correlation with patient 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 definitive 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
- All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
- Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks
- Negative results should be considered in the context of an individual's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
