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iHealth Self-Test at Home COVID-19 Antigen Rapid Test
Fast, accurate, easy, and comfortable.
For in-home, professional, or OSHA compliant employer use.
For in-home, professional, or OSHA compliant employer use.
- FDA-Authorized 15 Minute Self-Test
- Easy to Use. Zero Discomfort
- For Ages 2+
- Detect Current and New COVID Variants
- Group Testing Management via Mobile App
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 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 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.
- Test type: Antigen
- Run time: 15 minutes
- Collection type: Lower nasal swab
- Authorization: FDA EUA for home and over-the-counter use. No CLIA certification required.
- Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
- SARS-CoV-2: 94% Sensitivity, 98% Specificity (Self-Collected
- Specificity: No cross-reaction with species tested
- Interference: No interfering factors tested
- NDC# 56362000589
- EXPIRATION DATE: NOVEMBER 2025
- (2) Test devices: Foil pouched test device containing one test strip which is encased in plastic device cassette with a desiccant
- (2) Extraction vials and caps
- (2) Nasal swabs: swab for anterior nasal specimen collection
- Instructions for Use
The iHealth ® COVID-19 Antigen Rapid Test is an antigen test. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). The iHealth ® COVID-19 Antigen Rapid Test is able to detect small parts of theSARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions.
iHealth has completed testing on several heat inactivated variant strains and the iHealth® COVID-19 Antigen Rapid Test was able to detect the mutations. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
This test is authorized for nonprescription home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older.
Yes. If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests.
Self-Test at Home Results in 15 Mins
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.
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About iHealth
Empowering Healthier Lives.
iHealth is dedicated to empowering healthier lives. As a pioneer of digital health from Silicon Valley, iHealth was founded in 2010 and launched the world's first Bluetooth-connected blood pressure monitor that worked with iOS devices. Through more than a decade of development, by integrating its FDA-approved, award-winning consumer medical devices and remote patient monitoring platform, iHealth has established a digital health ecosystem, the Unified Care model, for healthcare providers to manage chronic diseases remotely. To date, iHealth is one of the top brands in digital health & wellness and has expanded its Unified Care model to 13 states with significant clinical outcomes in hypertension and diabetes management.
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