The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. Under FDA’s EUA, CareStart™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected 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 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 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.
Features:
- For use under Emergency Use Authorization Only
- For In Vitro Diagnostic Use Only
- Fast and easy to self-test at anywhere
- Easy to interpret the results using mobile application
- Qualitatively detect the SARS-CoV-2 nucleocapsid protein
- Use for nasal swab specimen
- Fast results only in 10 minutes
- Identify individual’s current infection status to COVID-19
- iOS13 or newer for Apple iPhone
- Android10 or newer for Android Phone
