iHealth COVID-19 Antigen Rapid Test Kit

iHealth COVID-19 Antigen Rapid Test Kit

Brand/Manufacturer: iHealth Labs Inc.
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  • Non Returnable

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Key Features of iHealth COVID-19 Test Kit

  • FDA authorized At-Home Rapid Covid Test Kit (EUA)

    The test has been authorized by FDA under an EUA; to detect proteins 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.
  • Easy to use & quick - zero discomfort Rapid Covid Test

    Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab. It's done in just 4 simple steps which are also included in step-by-step instructional videos that are available in our app for easy following(Installation of app is optional).
  • At-Home Covid Test Kit for ages 2 and above

    Self-administered testing is only recommended for individuals aged 15 years and older. Adult-collection is required for testing children under 2-14 years of age.
  • COVID-19 Test Kit that detects current and new 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
  • iHealth Test App enables easy management of group testing

    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 events.

 

What to buy with At-Home Rapid Covid Test Kit

 

How to test myself with the iHealth At-Home Covid Test Kit?

In order to perform self-administered testing for SARS-CoV-2 Antigen Test, you will need to follow the below steps with full precaution -

Preparing Materials for Self-Administered COVID-19 Testing

Wash or sanitize hands using a hand sanitizer. Make sure your hands are dry before covid testing. 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.

Collecting Non-Invasive Sample for Rapid Antigen Covid Testing

Collecting Nasal Sample for At-Home COVID-19 Testing

  • Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Using the same swab, repeat the same sample collection procedure for the other nostril. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Be sure to brush BOTH nostrils with the SAME SWAB.

Collecting Non-Invasive Nasal Cavity Sample for COVID19 Testing at Home

Processing the COVID-19 Sample At Home

COVID-19 Antigen Test Sample Preparation

  • Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.
  • 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.

Qualitative Detection of nucleocapsid protein antigen from SARS-CoV-2

  • Screw back the large orange cap, put the swab back into the package. Safely dispose of the swab and the package.
  • 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.

Detection of nucleocapsid protein antigen from SARS-CoV-2

  • Wait for at least 15 minutes for the results to appear. You can use a timer for further convenience.

How to Read COVID Test Results from the iHealth COVID-19 Test Strip?

Results should not be read after 30 minutes. A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

Positive COVID-19 Test Result

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.

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.

Testing Positive on At-Home Rapid Covid Test Card


Negative COVID Test Result

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 forCOVID-19.

Negative Result on iHealth Covid Test Card


Invalid Results of At-Home Antigen COVID Test

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.

Invalid COVID19 Test Results on iHealth COVID-19 Test Kit

Disposing the Test Kit & Reporting Results

  • Once test is completed, dispose of the kit components in trash and make sure to wash your hands thoroughly.
  • Report the results following in-app instructions or share them with your healthcare provider.

iHealth COVID-19 Antigen Rapid Test Kit Instruction For Use

 

Procedure To Use iHealth COVID-19 Test Kit

  • Easy Results Management - Each individual added to the group can test themselves at home and upload their results confidentially to the group manager within a selected timeframe.
  • iHealth Pass - Test results, once entered in the app, generate an iHealth Pass that can be used as digital proof of negative results for private events.
  • Vaccine Proof - The iHealth App allows you to store your vaccine record in the app for easy access.

 

iHealth COVID19 Antigen Test Kit FAQs

 

  • Will the iHealth COVID Test Kit detect other 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.
  • 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 the At-Home COVID 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.
  • Is a prescription required to perform the iHealth Rapid Covid Test?

    No, 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.
  • How far do I need to insert the Nasal Swab for collecting non-invasive sample?

    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.

Got more unanswered questions? Check out the complete list of frequently asked questions on iHealth COVID Test Kit -
iHealth COVID-19 Antigen Rapid Test Kit FAQs

 

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