Learn About iHealth COVID-19 Antigen Rapid Test

The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Please refer to the downloads section below for a full test facts sheet, FDA-EUA documentation, and the instructions for use documents.

• For use with anterior nasal swab specimens
• For in vitro Diagnostic Use Only
• This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization (EUA)
• Does not differentiate between SARS-CoV and
  SARS-CoV-2.
• Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 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 anterior 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 15 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.