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.
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.
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.)
The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
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 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.
Scan the QR code to download the App
View compatible phone models
iHealth COVID-19 Antigen Rapid Test is compatible with most Bluetooth enabled smartphones.
View compatible phone models
Fact Sheet for Health Providers
Healthcare Provider Instructions for Use
Quick Start Guide for Consumers
According to the Department of Health & Human Services, beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) will be able to have those test costs covered by their plan or insurance.
Insurance companies and health plans are required to cover 8 free over-the-counter at-home tests per covered individual per month.
You can find out from your plan or insurer on how to submit a claim to your insurance company for reimbursement. The following list shows information your plan or insurer may require when submitting a claim for iHealth COVID-19 Antigen Rapid Test.
1. UPC Code: 856362005890
2. NDC Code: 56362-0005-89
3. TAX ID (EIN): 80-0664152
4. NPI: 1710514476
5. Address: iHealth Labs, Inc., 150C Charcot Ave, San Jose, CA 95131
6. Receipt showing the date of purchase and testing kit charges
Please note that you have to contact your insurance company for the detailed reimbursement policy. If you need any other supporting documents in addition to the above listed information, please send an email to support@ihealthlabs.com
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.
For a demonstration on how the test works, watch the instructional video here.
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 tests are 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 type of 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.
For more information on COVID-19 testing, please see the following link: https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics
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 are the approved alternatives?There are no approved available alternative antigen tests. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
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 is serial testing?Serial testing is when a single person is tested for COVID-19 more than once. Because antigen tests are less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify individuals with COVID-19 more reliably than a single test. By repeating testing, it may be possible to more quickly identify cases of COVID-19 and reduce spread of infection. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. It is important that you work with your healthcare provider to help you understand the next steps you should take. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.
Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
Do I always need to perform two tests?If you have COVID-19 symptoms and are within the first 7 days of symptom onset, you can use one single test of the iHealth® COVID-19 Antigen Rapid Test. You may also choose to perform two tests if you wish. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
If you do not have COVID-19 symptoms or have been having symptoms for more than 7 days, 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.
Can this test be used as proof of a negative COVID-19 test for travel?No. Currently, the iHealth® COVID-19 Antigen Rapid Test cannot be accepted as proof of a negative COVID-19 test for travel.
Will the test work if I don't have symptoms?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.
Should people who are vaccinated use this test?Individuals can utilize this test, as needed, regardless of vaccination status.
Is a prescription required to perform this test?You do not need a doctor’s prescription to purchase and perform this test.
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.
What does it mean if I have a positive test result?A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is very likely to be infected with the virus and presumed to be contagious. Test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management decisions should be made by a healthcare provider and follow current CDC guidelines.
The iHealth® COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.
Test results are automatically reported through the “iHealth COVID-19 Antigen Rapid Test” App to relevant public health authorities in accordance with local, state, and federal requirements.
All healthcare providers must follow the standard testing and reporting guidelines according to their appropriate public health authorities.
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 currentlyrecommends 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.
Invalid result means that the test is not performed correctly. You will need to retest with a new test kit.
