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iHealth® COVID-19 Antigen Rapid Test

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Product Overview

Description

iHealth® COVID-19 Antigen Rapid Test

Self-Test at Home | Results in 15 minutes | Two (2) Test per Pack

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:

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.

Disclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance.
This is not a PCR test and not valid for travel. The manufacturer of the iHealth® COVID-19 Antigen Rapid Test requires test kits be stored at temperatures between 36o and 86oF (2o – 30oC). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit.

  • 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.

FDA Approval Letter for iHealth COVID-19 Antigen Rapid Test

Quick Start Guide for iHealth COVID-19 Antigen Rapid Test

Specifications

Description

iHealth® COVID-19 Antigen Rapid Test

Self-Test at Home | Results in 15 minutes | Two (2) Test per Pack

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:

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.

Disclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance.
This is not a PCR test and not valid for travel. The manufacturer of the iHealth® COVID-19 Antigen Rapid Test requires test kits be stored at temperatures between 36o and 86oF (2o – 30oC). Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit.

  • 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.

FDA Approval Letter for iHealth COVID-19 Antigen Rapid Test

Quick Start Guide for iHealth COVID-19 Antigen Rapid Test

How does the iHealth® COVID-19 Antigen Rapid Test work?

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.

Will this test detect COVID-19 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. 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.

What are the differences between a COVID-19 antigen, molecular and antibody test?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests)detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen test sare very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Another typeof test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable to diagnose an active COVID-19 infection.

How accurate is the iHealth® COVID-19 Antigen Rapid Test?

Based on the results of a clinical study where the iHealth® COVID-19 Antigen Rapid Test was compared to an FDA authorized molecular SARS-CoV-2 test, iHealth® COVID-19 Antigen Rapid Test correctly identified 94.3% of positive specimens and 98.1% of negative specimens.

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.

Is this iHealth® COVID-19 Antigen Rapid Test Kit FDA approved or cleared?

No. This test is not yet approved or cleared by the United States FDA. FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used).

What is the age range for the test?

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.

What should I do if my test result is positive?

If your test result is positive with the iHealth® COVID-19 Antigen Rapid Test, you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms. The CDC currently recommends several Steps to help prevent the spread of COVID-19 if you are sick, detailed guidance could be found at: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html

What does it mean if I have negative test results?

A negative test result for this test means that antigens from SARS-CoV-2 were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. The amount of antigen in a sample may decrease as the duration of illness increases. In symptomatic patients, specimens collected after day 5 of illness may be more likely to be negative compared to a RT-PCR assay. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities.

Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance) (see links provided in “Where can I go for updates and more information” section).

The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in between May and October 2021.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.

What should I do if I have COVID-19 symptoms BUT my test result is negative?

If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. If you are concerned about your COVID-19 infection status after testing or think you may need follow up testing, please contact your healthcare provider as well.

If you will not have an additional test to determine if you are contagious, the CDC currently recommends that you should stay home until three things have happened:
  • You have had no fever for at least 24 hours (that is one full day of no fever without the use of medicine that reduces fevers) AND
  • Other symptoms of COVID-19 are improving (for example, when your cough or shortness of breath has improved) Note: Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation AND
  • At least 10 days have passed since your symptoms first appeared.
What does it mean if I have invalid test results? Invalid result means that the test is not performed correctly. You will need to retest with a new test kit.

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