BTNX

Rapid Response Covid19 Home Antigen Test

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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 nonlaboratory 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 for ages 14 or older
Adult collecting from individuals aged 2 years or older

People who test positive with the Rapid Response COVID-19 Antigen Rapid Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary. Positive results do not rule out bacterial infection or co-infection with other viruses.

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