• SCoV-2 Ag Detect Rapid Self-Test is for use under an FDA Emergency Use Authorization:
• The SCoV-2 Ag Detect Rapid Self-Test 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 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 5 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 test
• Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
• Individuals who test positive with the SCoV-2 Ag Detect Rapid Self-Test 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

Product Specs