COVID-19 Antigen Rapid Test

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.

GROUP TESTING MANAGING VIA MOBILE APP
The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results when needed at school, work or event.

Description

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

3 days with at least 24 hours (and no more than 48 hours) between tests.

Clinical Performance

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.

Additional asymptomatic individuals and individuals beyond the seven days of symptom onset were tested, but excluded from the primary performance calculations because they were not included in the intended use. A higher proportion of low positive specimens were observed in these populations, resulting in PPAs between of 85-88% in these individuals.

Get instant COVID test results in 15 minutes.

New variants have shown that anyone can be vulnerable to COVID-19 even if they are vaccinated or young. With iHealth COVID-19 Antigen Rapid Test, you can test yourself after being out in public. Early and regular testing helps you better care for yourself and protects your friends, family, and community members from potential exposure.

4 Steps. 15 Minutes. Zero Discomfort.

iHealth COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen. It only takes 4 steps and 15 minutes to complete the test. The test is also non-invasive. You won’t need to collect a sample from deep in your nasal cavity to get accurate results.