Disclaimer: None of the information in this article constitutes medical advice, and is just the opinion of the writer(s), and is presented for informational purposes only. We recommend that patients follow their doctor’s guidance in regard to medical testing.
iHealth is a medical device brand which sells one of the leading COVID-19 test products, called the iHealth COVID-19 Antigen Rapid Test. Their tests are advertised as Centers for Disease Control (CDC) compliant, meaning the test results can be used as proof of health status for re-entry into the United States after international travel.
In this article we’ll review iHealth’s COVID test based on published medical research to determine if it’s the most accurate type of COVID testing, or if there are alternatives we would recommend instead.
What is Antigen Testing?
iHealth’s test is an antigen test. We believe it’s important for patients to understand the different types of infection testing for COVID.
Antigen testing is a type of medical testing commonly performed to detect respiratory infections. It’s not only used to detect COVID-19, but also to detect the common flu.
According to the CDC, antigen tests are most accurate when performed while the patient is symptomatic.
The way antigen tests actually work, according to the American Society for Microbiology, is by detecting a specific type of protein unique to COVID-19 from patient swabs.
Antigen tests provide results back to the patient quickly; typically in under an hour and often in under 30 minutes. This is one of their advantages compared to other types of infection testing.
Is iHealth’s Test Accurate?
Antigen testing is less accurate than a different type of testing called Reverse Transcription-Polymerase Chain Reaction (RT-PCR), as we outlined in our Everlywell review article about a similar COVID testing service.
Medical research has proven that RT-PCR testing is more accurate. The linked study compared accuracy of antigen and RT-PCR testing in real-world medical settings, and found that RT-PCR results were more accurate.
The study authors noted that in asymptomatic patients especially, antigen testing was significantly less accurate, leading them to conclude that RT-PCR tests should be the default option when a patient is suspected to have COVID-19: “The lower sensitivity of antigen tests compared with RT-PCR testing supports the strategy of using a more sensitive NAAT test if there is high clinical suspicion for COVID-19.”
iHealth’s test is still likely to be accurate, and certainly better than nothing, but we don’t find it to be a good option compared with RT-PCR testing which is becoming the medical standard.
How Accurate is the iHealth COVID Test?
There doesn’t appear to be any published medical research on the exact accuracy of the iHealth device, but there is research on the accuracy of rapid antigen tests for COVID-19 generally.
Since this is a well-established type of medical testing, and since iHealth’s device has been approved by the Food and Drug Administration (FDA) in the U.S., we can assume that the accuracy of iHealth tests is similar to the general accuracy of antigen tests.
The accuracy of COVID-19 antigen tests is measured in terms of sensitivity and specificity. Sensitivity measures the likelihood of an antigen test correctly diagnosing an infectious patient as infectious, while specificity measures the likelihood of an antigen test correctly diagnosing a non-infectious patient as non-infectious.
Medical research has shown antigen tests to have a sensitivity of 82% in symptomatic patients and 68% in asymptomatic patients. We don’t find these to be particularly impressive results. This means that the rapid antigen testing provides a false negative result to an infectious patient 32 times out of 100 on average.
This data demonstrates why frequent testing is so important for patients who only have access to rapid antigen tests for COVID-19. The probability of an asymptomatic patient receiving a false negative twice in a row is only 10%, rather than 32% for a single test.
Free COVID Testing Options
If you can access more accurate COVID testing at a lower cost, it seems logical to do so.
We’ve already established that RT-PCR testing is more accurate than the antigen testing provided by iHealth, and there are several resources available to U.S. patients for finding free RT-PCR COVID testing sites.
The pharmacy brand CVS has over 4,800 COVID-19 testing sites and all of them are free to the patient. Input your ZIP code and find the closest location to you: https://www.cvs.com/minuteclinic/covid-19-testing
The Department of Human Health Services (HHS) in the U.S. maintains an updated database of over 20,000 sites where patients can access free COVID testing, both RT-PCR and antigen testing depending on location. Resource here: https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html
The U.S. government also will ship COVID tests to your door at no cost. Find more information here: https://www.covid.gov/tests
In some situations patients may find a need for a paid COVID testing service, but unless it’s more accurate it seems illogical to us in the vast majority of situations to pay for iHealth’s service when there are so many free options, many of them likely to be more accurate.
Abbott Vs. iHealth COVID Test
Abbott is a pharmaceutical company that manufactures a COVID test called BinaxNOW. Like iHealth’s test, it has been authorized for emergency use by the FDA.
Both tests are antigen tests, so we don’t believe there’s any reason to prefer one over another. There have been no medical studies directly comparing the efficacy of the two tests, but they’re likely to be equally accurate.
It is notable that BinaxNOW has been tested in several published medical studies, while we can’t find any studies on iHealth’s device.
We recommend using whichever option is cheaper, but would recommend BinaxNOW over iHealth’s Antigen Rapid Test if both tests are the same price or free.
iHealth COVID Test Instructions
iHealth has an instruction manual which isn’t very easily accessible or well-defined on their site. To access the test instructions, you need to go to their test details page, and scroll down to the “Downloadable Resources” header.
The test instructions can be downloaded by clicking on the “Quick Start Guide for Consumers” link.
We don’t understand why they title their instructions “Quick Start Guide for Consumers” rather than “Instructions for Use” which would be much more clear. Their website has a notably poor user experience in our opinion, especially for a medical device company.
Here is a summary of their instructions:
- Prepare materials
- Collect sample
- Process sample
- Add sample
- Wait 15 minutes
- Read result
- Test result explanation
- Dispose the test kit
The entire process should take under 30 minutes.
Where Are iHealth COVID Test Kits for Sale?
iHealth COVID test kits are for sale both on their website and on Amazon.
Website link: https://ihealthlabs.com/
At the time of writing, the price is exactly the same on both platforms.
iHealth COVID test kits are also for sale on some third-party websites, but we would recommend avoiding those because it’s impossible to guarantee authenticity. If you buy from iHealth’s website or their official Amazon listing which we’ve linked to, you’ll ensure you’re getting a product manufactured by iHealth.
How Should I Interpret iHealth COVID Test Results?
Because rapid antigen testing can provide false negative results nearly 35% of the time based on medical studies, we recommend that patients reach out to their doctor about potentially performing another test if they receive a negative result.
False negatives can delay proper treatment and increase the risk of complications from infectious disease, so minimizing this risk with multiple tests upon receiving an initial negative result seems logical, but should be discussed with a healthcare professional.
Does the iHealth COVID Test Detect Omicron?
We can’t find any medical research proving that the iHealth COVID test can detect Omicron. It likely can in most cases, due to the protein being the same, but we cannot conclusively say until it’s been proven in medical studies.
iHealth issued a press release indicating that they “are confident” their product will detect Omicron, but without conclusive proof we find these statements to be less useful.
Abbott’s BinaxNOW test has been proven in one medical trial to effectively detect the Omicron variant, so that product may be a superior option for patients who believe they’ve been exposed to Omicron.
Are iHealth COVID Tests FDA Approved?
No. The FDA has issued Emergency Use Authorization (EUA) to iHealth due to the public risk of the COVID-19 pandemic, but this product has not completed the formal FDA approval process, as documented by the FDA.
As the linked document published by the FDA states, the iHealth test “is not yet approved or cleared by the United States FDA.”
There are currently no rapid antigen tests that are approved by the FDA.