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.
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 nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
Dimensions (Single Pack):
- 6.18 x 3.19 x 0.71 inches (LxWxH)
- 0.13 lbs.
- 13.1 x 11.8 x 10.8 inches (LxWxH)
- 12.8 lbs.
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 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.
- This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
- This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Disclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance.
iHealth® COVID-19 Antigen Rapid Test may take several days to ship. This is not a PCR test and not valid for travel. The manufacturer of the iHealth® COVID-19 Antigen Rapid Test requires test kits be stored at temperatures between 36o and 86oF (2o – 3oC). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit.