iHealth COVID-19 Antigen Rapid At Home Test (2 Pack)

$39.95
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Package includes 2 individual tests

iHealth COVID-19 Antigen Rapid Test is the easiest and fastest way to find out if someone has been infected with COVID-19. You get results within 15 minutes and it is non-invasive. You don't need to collect a sample from deep in your nasal cavity to get accurate results.

New variants have shown that anyone can be vulnerable to COVID-19 even if they have been vaccinated or healthy. If you have reason t believe you or someone close to you may have been exposed to the virus, take the iHealth COVID-19 Antigen Rapid Test for immediate peace of mind. Early and regular testing helps you better care for yourself and protects your friends, family, and community members from potential exposure.

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. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

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.

CLINICAL DATA:

  • Sensitivity 94.3%
  • Specificity 98.1%

 

DETAILS:

  • FDA Authorized 15-Minute Self-Test: The test is a 15-minute self-test to detect whether or not an individual has COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
  • 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.
  • Easy to Use with Zero Discomfort: Test can be done by inserting 1/2 to 3/4 inch of a simple non-invasive nasal swab. Step-by-step instructional videos are available in our app (Installation of app is optional)
  • 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
  • Manage Group Testing Via Mobile App: The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results as needed at school, work or an event

DOCUMENTATION:

 

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CERTIFICATION STATUS

This product has been authorized by FDA under an EUA. It has not been FDA cleared or approved. 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.