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.
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.
Download the app
(Use of App is optional)
Download the App
(Use of App is optional)
Available on the App Store and Google Play.
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.
iPhone 7 Plus
iPhone 8 Plus
iPhone 11 Pro
iPhone 12 Pro
iPhone 12 Pro Max
iPhone XS Max
LG Stylo 5X
Moto G8 Power
Moto G7 Plus
Samsung Galaxy Note8
Samsung Galaxy Note9
Samsung Galaxy S10
Samsung Galaxy S20
Samsung Galaxy S6
Samsung Galaxy S8
Samsung Galaxy S9
Google Pixel 4a
View compatible phone models
FDA EUA Letter
Fact Sheet for Health Providers
Healthcare Provider Instructions for Use
Quick Start Guide for Consumers
Frequently Asked Questions (FAQs)
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 firstname.lastname@example.org
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.
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.
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
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).
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
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.
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.
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.
No. Currently, the iHealth® COVID-19 Antigen Rapid Test cannot be accepted as proof of a negative COVID-19 test for travel.
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.
Individuals can utilize this test, as needed, regardless of vaccination status.
You do not need a doctor’s prescription to purchase and perform this 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.
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.
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:
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.
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.
No, DO NOT use it on anyone under 2 years old.
No. All the components of iHealth® COVID-19 Antigen Rapid Test Kit are not reusable and can only be used once.
No, the nasal swab is not sharp, and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test, and seek advice from a healthcare provider.
Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.
With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have a second person to hold the child’s head while swabbing
In some cases, it has been observed that only one nostril has the detectable virus. Swabbing both nostrils is important because it gives you the best chance of a collecting sufficient sample to generate an accurate result.
Yes. The iHealth ® COVID-19 Antigen Rapid Test can be used with or without any noticeable symptoms of COVID-19 (including a blocked or runny nose).
Once the Test Card is removed from the pouch, perform the test as soon as possible. Use the Test Card within 1 hour after opening the foil pouch.
Yes. After adding the sample to the sample port, do NOT confirm your result before your 15-minute timer is up. The positive indicating line would take as long as 15 minutes to appear, so you may get an incorrect result (false negative) if you do not wait for 15 minutes.
Potential risks include: • Possible discomfort or other complications that can happen during sample collection. • Possible incorrect test result (see below for more information).
Potential benefits include: • The results, along with other information, can help your healthcare provider make informed recommendations about your care. • The results of this test may help limit the spread of COVID-19 to your family and others in your community.
No. Use of app is optional. You can follow the paper instructions to perform the test if you wish.However, we do recommend you use the iHealth COVID-19 Test App as step-by-step instructional videos are available in the app for more intuitive understanding of how to perform the test correctly. In addition, the health pass and group testing features in the app would benefit you in your daily life.
The iHealth COVID-19 Antigen Rapid Test app saves your test results if you select and submit your results within the App. This record can be shared with your healthcare professional as proof of COVID-19 testing. Your date of birth and zip code, together with test results, are the information required as they are shared with the relevant health authorities to support monitoring of COVID-19 infection and test positivity rates across the country.
If you leave the iHealth COVID-19 Antigen Rapid Test app during test without exiting it, you may be able to return to the same screen. If you exit the app during your test or if the app was force quit by accident, a button to continue your test will be available on the home page once you re-open the app. However, we recommend keeping the app on the screen until you get your result to avoid any possibility of interrupting the test.
The iHealth COVID-19 Test App is compatible with most smartphones with operation systems iOS 12 or above, android 6.0 or above. Below is the full list of compatible smartphones.
The following people are considered high risk for severe disease:
People aged 65 and older
People in nursing homes or long-term care facilities
People of all ages with underlying medical conditions, particularly if they are not well controlled
Chronic obstructive pulmonary disease
Chronic kidney disease
Immunosuppressed following solid organ transplant
Obesity (BMI >30)
Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
Sickle cell disease
Type II Diabetes
People may be at increased risk due to the following conditions:
Cerebrovascular disease (affecting blood vessels to the brain)
High blood pressure
Immunocompromised (weakened immune system) from blood or bone marrow transplants, immune deficiencies, HIV, use of corticosteroids, use of other immune weakening medications
Neurologic conditions such as dementia
Type I Diabetes
The Swab is sterile and safe to use. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril (Note: With children, you may not need to insert the swab as far into the nostril.). You may experience some discomfort when swabbing your nose, but this is to be expected. Do not insert the Swab any further if you experience sharp pain.
In the unlikely event your nose starts bleeding, do not insert the Swab again. Apply pressure to your nose until the bleeding stops and consult a healthcare professional.
No. You will need to obtain a new test kit. The swab with Extraction Reagent cannot be used for sample collection, the Extraction Reagent contains harmful chemicals (refer to Hazardous Ingredients for Reagent Solution part of Instructions for Use).
The liquid should be wiped off your phone or surface immediately as per the recommendations of your phone manufacturer. Please note that you may not have sufficient liquid remaining to perform the test and may need to obtain a new test kit.
No, do not reuse any test components. Please obtain a new test kit and perform a new test.
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To Whom It May Concern,
It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. market.
We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc.
Please be cautious of the following situations:
When the seller offers the pricing below market rates;
When the seller claims that they can import iHealth tests directly from China.
Below is a list of iHealth’s authorized distributors (in alphabetical order):
Biolabs International LLC / GriffMaier LLC
Concentric Health Alliance Inc
Eighty6 Medical LLC
Focus Industries Med LLC
MJM Sourcing LLC
Paramount Sourcing LLC (exclusively partnered with Office Depot)
Sunshine Paper LLC / Marketing Promotion Image Inc
If you want to verify whether a seller not on the list is authorized to distribute iHealth tests, please contact us at email@example.com.