iHealth®  COVID-19 Antigen Rapid Home Test Kit

2 Tests/Pack | 90 Tests/Case | FDA EUA Authorized OTC at-Home Self Test | Results in 15 Minutes with Non-invasive Nasal Swab | Easy to Use & No Discomfort |For In Vitro Diagnostic Use Only

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.

KEY FEATURES

• 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.
• 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.)
• 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.
• 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.
• 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.

Expiration Date Extension- On March 29, 2022, the FDA granted a three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests from 6 months to 9 months. For example, if the expiration date printed on your box says 2022-07-21 (YYYY-MM-DD), the updated expiration date is 2022-10-20 (YYYY-MM-DD). Please refer to the FDA website for the detailed list: https://www.fda.gov/media/158007/download

Legal Disclaimer- 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.

SIENNA™ COVID-19 Rapid Antigen Test Cassettes

*For Professional In-Vitro Diagnostic Use Only. CLIA number is required for purchase.*

10 Minute Point of Care (POC) Rapid Antigen Test created for the qualitative detection of COVID-19 antigen.

It is intended to aid in the rapid diagnosis of COVID-19 infections.

The Sienna COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid protein of SARS-CoV-2.

POINT-OF-CARE:

The Sienna nasal swab test kit is a point-of-care immunodiagnostic test that can be administered anywhere, does not require samples to be sent to a lab and delivers a result in ten minutes.

ASSESSMENT TOOL

Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV).

QUALIUTY ASSURANCE 

The Sienna test kit is 100% manufactured in Finland (with no components sourced from China) by a leading European in vitro diagnostics company.

Unmatched Convenience

• Visual Results: Easy to interpret.
• Fast Results: 10-minute test time.
• Individual Buffer Vials and Swabs:  Helps in testing multiple individuals simultaneously.

Accurate Results

• Sensitivity: 95.0%
• Specificity: 99.2%
• Accuracy: 98.8%

The kit includes:

• (1) IFU
• (1) Workstation
• (25) Individually Pouched cassettes
• (25) buffer tubes
• (25) sterile swabs

Procedure: During the testing process, the extracted specimen reacts with the antibody of the SARS-CoV-2 nucleocapsid protein that are coated onto particles. The mixture migrates into the membrane to react with the antibody for the SARS-CoV-2 nucleocapsid protein on the membrane and will generate one colored line in the test regions. The presence of this colored line in the test regions indicates a positive result. A colored line will always appear in the control region to serve as a procedural control if the test has been performed correctly.