BTNX Rapid Response® COVID-19 Antigen Rapid Test Device

The Rapid Response™ COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a non-laboratory setting with direct anterior nasal (nares) swab samples for: Unobserved self-collection for individuals aged 18 years or older Adult supervised self-collection for individuals age 14 or older Adult collecting from children 2 years or older This test is authorized for home use only under the Health Canada Interim Order.