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.

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.

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.

Key Features

1、FDA AUTHORIZED 15 MINS SELF-TEST

The test is a 15-minute self-test to detect whether or not an individual has the COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.

2、EASY TO USE ZERO DISCOMFORT

Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use and zero discomfort. Step-by-step instructional videos are available in our app for easy following. (Installation of app is optional.)

3、FOR AGES 2 AND ABOVE

The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.

4、DETECT CURRENT AND NEW COVID VARIANTS

iHealth has completed testing on several heat inactivated variant strains and the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations.

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)

INTENDED USE

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 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.