iHealth® At-Home COVID-19 Test

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Prepare Materials

  1. You may have Test Set 1 OR Test Set 2 in the package. Please follow proper steps based on the specific set you received.
  2. Test Set 1: Open the package, take out the COVID-19 Test Card in Pouch, the Tube filled with the extraction buffer and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19 Test Card.
  3. Please go directly to Step 2 Collect Sample
  4. Test Set 2: Open the package, take out the COVID-19 Test Card in Pouch, empty Tube, sealed Solution and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19 Test Card.
  5. Please look carefully, there are two Edges on the empty tub. Then squeeze the sealed solution completely into the empty tube.
  6. Please confirm the liquid level with or above Edge 2, then go to Step 2 Collect Sample.
    Note: It is acceptable if the liquid level is above Edge 2. However, please do not proceed with this test if the liquid level is below Edge 2, as this may result in false or invalid results.

Collect Sample

  1. Remove the swab from its package, being careful not to touch the tip of the swab. Please keep the swab package for later use.
  2. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.
    Note: With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child's head while swabbing.
  3. Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Using the same swab, repeat the same sample collection procedure for the other nostril. Be sure to brush BOTH nostrils with the SAME SWAB.
    Note: Failure to swab properly may cause false negative results.

Process Sample

  1. Tap the tube vertically on the table and twist the large orange cap to open the tube.
  2. Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.
  3. Squeeze the sides of the tube to express as much liquid as possible from the swab, and then remove the swab.
    Note: If you don't squeeze the swab, there may not be sufficient sample material to perform the test properly (i.e., potentially resulting in a false negative result).
  4. Screw back the large orange cap, put the swab back into the package. Safely dispose of the swab and the package.

Add Sample

  1. Twist to open the small white cap of the tube. Add 3 drops of sample to the Sample Port of the COVID-19 Test Card. Screw back the small white cap.
    Note: A false negative or invalid result may occur if too little solution is added to the test card.

Wait 15 Minutes

  1. Start the timer by clicking the “Start Timer” button, immediately after adding sample to the Sample Port. The result will be ready in 15 minutes.
    Note: Do NOT interpret your test result until after your 15-min timer has completed, as the T line may take as long as 15 minutes to appear.

Read Result

  1. Results should not be read after 30 minutes (Result shown at 2x magnification).
    NOTE: A false negative or false positive result may occurif the test result is read before 15 minutes or after 30 minutes.
    NOTE: The T line can be extremely faint.

Test Result Explanation

  1. A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19.
  2. A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19.
    Below are photos of actual positive tests. Please note that the T line may be faint.
  3. Persons who test positive should self-isolate and seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary.
  4. A NEGATIVE result will show ONLY a C line. A negative result means that viral antigens from COVID-19 were not detected and that the individual is presumed negative for COVID-19.
    • Please note that negative results do not rule out COVID-19.
    • In case of negative test result: Continue to follow all social distancing recommendations and take protective measures. If suspicions of infection persist and/or your first test is negative, repeat the test after 1-2 days and consult your healthcare provider or local COVID-19 center.
    • Note: A negative result is presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Individuals without symptoms that test negative should be tested again with at least 24 hours and no more than 48 hours between tests. Additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.
  5. If there is NO LINE, or if there is ONLY a T line, the test is INVALID. Invalid result means that the test did not function correctly. You will need to retest with a new test kit. If upon retesting, the test result is still invalid, contact your doctor or local COVID-19 center. An invalid result does not indicate if the individual did or did not have COVID-19 and should be repeated.

Dispose the Test Kit

  1. After test is completed, dispose the kit components in trash.

Report Test Result

  1. Report the result following the App instructions or share your test result with your healthcare provider.
  2. In the U.S.A. (1) This test is intended to be used as an aid to the clinical diagnosis of a current COVID-19 infection, Do not use this test as the only guide to manage your illness. (2) In USA - This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other virus or pathogens. 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.

Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection.

SARS-CoV-2 Coronavirus

The GoToKnow™ COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Testing Use

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 anterior nasal (nares) 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 (nares) 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.

Materials provided in the Test Kit

Each kit contains the following components: COVID-19 Test Card(s), Nasal Swab(s), Tube(s), User Instruction for Use.

This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA).

About the test

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

The iHealth COVID-19 Antigen Rapid Test is designed to detect proteins of the SARS-CoV-2 virus (the virus that causes Covid-19) in 15 minutes from a nasal swab.

Will the iHealth® COVID-19 Antigen Rapid Test detect COVID-19 variants?

iHealth has completed testing on several heat inactivated variant strains and 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?

Viral tests, sometimes called diagnostic tests, can detect if you have SARS-CoV-2, the virus that caused COVID-19. There are two types of diagnostic tests: molecular and antigen. A molecular test (commonly referred to as a PCR test) is designed to detect genomic material from the virus. Antigen tests (sometimes referred to as paid tests) detect specific proteins on the surface of the virus.

Antibody tests look for antibodies in your blood that fight off the virus. Antibodies can be found in your blood from either a past infection or vaccination. An antibody test cannot tell you if you currently have COVID-19.

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 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 may be less sensitive than molecular COVID-19 tests and false results may occur, repeat testing may identify individuals with COVID-19 more reliably than a single test. By testing more frequently, it may be possible to identify cases of COVID-19 and reduce spread of infection.

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.

Can this test be used as proof of a negative COVID-19 test for travel?

Learn more about CDC’s COVID-19 testing requirement for international travel to the United Stateshere.

https://www.cdc.gov/coronavirus/2019-ncov/travelers/testing-international-air-travelers.html (link connects to this)

For other conditions such as a cruise, entry to a foreign country, private events, etc., it will depend on the specific organization’s requirements if a verified test can be accepted as proof of a negative test.

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?

To determine if you’re eligible for reimbursement, please contact your health insurance provider.

Is a prescription required to perform this test?

You do not need a doctor’s prescription to purchase and perform this test.

Result & Accuracy

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 an Inconclusive test result?
An inconclusive result is neither positive nor negative. This result can occur from inadequate sample collection, very early-stage infection, or for patients close to recovery. With an inconclusive result, collecting and testing another sample is recommended.

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.

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 may 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 means that proteins from SARS-CoV-2 were not present in the specimen above the limit of detection. The amount of virus 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 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 did not function correctly. You will need to retest with a new test kit.

Using the test

Can the iHealth® COVID-19 Antigen Rapid Test be used in children under two years old?

No, the test is not authorized for anyone under 2 years of age.

Is the iHealth® COVID-19 Antigen Rapid Test reusable?

No. All the components of iHealth® COVID-19 Antigen Rapid Test Kit are not reusable and can only be used once.

Will the test hurt?

No, It should not hurt if used as directed. The nasal swab is not sharp, but sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test, and seek advice from a healthcare provider.

How far do I need to insert the Nasal Swab?

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.

Why must I swab both nostrils?

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.

Can I perform the test if I don’t have a blocked or runny nose?

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) or other epidemiological reasons to suspect COVID-19.

How much fluid should I squeeze into the sample port of the Test Card?

3 drops.

Within how much time should the test card be used, after the foil pouch is opened?

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.

Do I have to wait for 15 minutes to read the result?

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 could 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.

What are the known and potential benefits and risks for the home test?

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.

Health

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 are not 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 or cardiomyopathies
  • Sickle cell disease
  • Type II Diabetes

People 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 as directed. 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

I 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).

What should I do if some of the liquid splashes onto my phone or anywhere else except the sampling port?

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.

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.

Disclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance.

iHealth® COVID-19 Antigen Rapid Test may take several days to ship. 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.