iHealth COVID-19 Self-Test At-Home, 2 Tests/Kit

Description Of Our iHealth Covid-19 Self-Test Kit

EXP DATE: January 5th, 2025

Expiration Date Extension: On Jan 11, 2023, the FDA granted another 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 15 months. Please refer to the FDA website for the detailed list of extended expiration dates by lot numbers.

The Ihealth tests are a 15-minute self-test to detect nucleocapsid protein antigen from SARS-CoV-2. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.

Please call us at 1-877-597-3224 or e-mail us sales@peachmedical.com for wholesale pricing. We are more than happy to provide references within production, government, finance, education, fortune 500 companies, and more. Over 1,000,000+ orders of test kits sold over the past year.

EASY TO USE ZERO DISCOMFORT

The test can be done by inserting only 1/2 to 3/4 inches with a simple non-invasive nasal swab, easy to use, and has zero discomfort. Step-by-step instructional videos are available in our app for easy following. (Installation of the 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 in-lab testing on several heat-inactivated variant strains and the results show that the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations of both the Delta and Omicron variants.

GROUP TESTING MANAGING VIA MOBILE APP

The iHealth COVID-19 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.

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.

ihealth tests are 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.

DISCLAIMER

Please note that all Peach Medical shipments do not require a signature upon delivery. Since most test kits should be stored between 35.6 and 86 degrees F range, we strongly recommend that you track your order and anticipate its delivery. However, if the test is stored outside the temperature range for a relatively short period of time – for a couple of hours up to a day or two – it will be fine to use as long as the test and its components are used at room temperature. Peach Medical is not responsible if the test kits are left outside in extreme temperatures for longer than the recommended time frame after delivery.

FAQ

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 can detect small parts of the SARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions.

Will this test detect COVID-19 variants?

iHealthcovid test 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 is the difference 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 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 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.

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 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 tests 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 this test covered by insurance?

The test is available for self-test at home without a prescription. Please consult with your health insurance to make sure if your test will be covered.

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

Based on the results of a clinical study where the iHealth® COVID-19Antigen 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 positive test results?

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 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 by 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.

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 the illness increases. In symptomatic patients, specimens collected after day 5 of illness may be more likely to be negative compared to an 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 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.

Do I have to use the app?

No. Use of the 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 a 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.

Why is the iHealth COVID-19 Test App asking me for my personal information?

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 the monitoring of COVID-19 infection and test positivity rates across the country.

Can I leave or exit the iHealth COVID-19 Test App while the test is still running?

If you leave the iHealth COVID-19 Antigen Rapid Test app during the 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 forced to 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.

What devices are compatible with the iHealth COVID-19 Test App?

The iHealth COVID-19 Test App is compatible with most smartphones with operation systems iOS 12 or above, and Android 6.0 or above. Below is the full list of compatible smartphones. Apple iPhones: iPhone 7, iPhone 7 plus, iPhone 8 plus, iPhone 10, iPhone11, iPhone 11 Pro, iPhone 12, iPhone 12 max, iPhone 12 pro max, iPhone SE, iPhone SE2, iPhone X, iPhone X, iPhone XR, iPhone XS, iPhone XS MAXAndroid Phones: LG Stylo 5X, Moto G8 Power, Moto G7 Plus, SamsungGalaxy Note8, Samsung Galaxy Note9, Samsung Galaxy S10, SamsungGalaxy S20, Samsung Galaxy S6, Samsung Galaxy S8, Samsung Galaxy S9, Google Pixel 4a, Huawei P20Health

Who is considered high risk for severe disease?

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 arenot well controlled• Cancer• 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 orcardiomyopathies• Sickle cell disease• Type II DiabetesPeople may be at increased risk due to the following conditions:• Asthma (moderate-severe)• Cerebrovascular disease (affecting blood vessels to the brain)• Cystic fibrosis• 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• Liver disease• Pulmonary fibrosis• Smoking• Thalassemia• Type I Diabetes• Can I injure myself using the swab? 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.

I have a nosebleed after swabbing my nose. What should I do?

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.

troubleshooting inserted the nasal swab into the tube before I swabbed my nose.

Can I re-use the swab?

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).

I received an invalid result when I performed the test and I need to use a new test kit. Can I use the same sample I used in the previous test?

No, do not reuse any test components. Please obtain a new test kit and perform a new test.

This product has not been FDA-cleared or approved, but has been authorized by FDA under a 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.

Important Documents

Manufacturer Extension

IHealth Fact Sheet

IHealth Laboratories FDA Emergency Use Authorization

At-Home Test Instructions For Use

FDA Extension Letter

Shipping and Returns

How Long Does It Take For My Item(s) To Ship?

Items are shipped Monday - Friday from our warehouse. 1-2 Day Processing Time.Delivery times vary according to your selected delivery address, the availability of your items, and the time of day you place your order.For B2B accounts, please get in touch with us at sales@pechmedical.com for urgent order requests.Please feel free to visit our Support Page for FDA Extension Letters, Submit a Ticket, and more.

What Shipping Methods Do You Offer?

At Peach Medical Corp we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. Currently, our shipping methods are as follows:

• UPS Next Day Air
• UPS 2nd Day Air
• UPS Ground (3-5 Day Delivery)

When Will I Receive My Tracking Number?

Our system updates clients every evening with tracking numbers for their orders. This will be sent via e-mail with an additional copy of your receipt.

Incorrect Address

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical Corp. is not able to have packages rerouted or contact the carrier for you.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please contact the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

The Peach Medical COVID-19 Antigen Rapid Test and all face masks are Non-returnable & Non-refundable as they are considered personal-use items. Replacement may be shipped if the item is defective. Proof of purchase, photos of defects, lot numbers, and other information are required to authorize a replacement. Please reach out to customer service for detailed requirements before disposing of the defective units. We will not replace your COVID-19 Antigen Rapid Test kits that are expiring soon based on the printed label. Our expiration dates have been shown on each product page. More information can be found at support.peachmedical.com/portal/en/kb/peachmedicalsourcing. We will continue to update the FDA documents for shelf-life extensions for our tests.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once they leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services.

All Products must be packed in the original, unopened, and unmarked packaging including any accessories, manuals, documentation, and registration that shipped with the Product.Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored. Please email us at support@peachmedical.com for return authorization and the shipping address.