iHealth COVID-19 Antigen Rapid Test Review: Is It Accurate? (2022)

iHealth COVID-19 Antigen Rapid Test Review: Is It Accurate? (1)

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.

(Video) iHealth Rapid Antigen Test Accuracy

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.

(Video) How to use the iHealth COVID-19 Antigen Rapid Test

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.

(Video) Demonstration on using iHealth COVID-19 Antigen Rapid Test

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:

  1. Prepare materials
  2. Collect sample
  3. Process sample
  4. Add sample
  5. Wait 15 minutes
  6. Read result
  7. Test result explanation
  8. 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/

Amazon link: https://www.amazon.com/iHealth-COVID-19-Authorized-Non-invasive-Discomfort/dp/B09KZ6TBNY/

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.

(Video) Former FDA chief Dr. Scott Gottlieb on accuracy of rapid Covid-19 tests

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.

Conclusion

iHealth manufactures a COVID-19 testing device which may be useful for patients who need results quickly to travel, but the type of testing that the iHealth product is based on is less accurate than RT-PCR tests.

We would recommend that patients speak to their doctor about RT-PCR testing if time isn’t an urgent issue.

There are many free COVID testing options for patients in the U.S., and we would recommend any free option over paying for iHealth’s product.

(Video) iHealth COVID-19 Antigen Rapid Test, 2 per Pack, Self Test, Results in 15 Min Warning: Kinda Gross!

Abbott’s BinaxNOW testing product may be a better option for patients exposed to the Omicron variant, because it’s been proven in medical research to be effective at detecting that variant, but otherwise we see no major differences between the two tests.

There seems to be good logic behind completing more than one rapid antigen test in the event of a negative result, because false negative rates are relatively high with rapid antigen testing.

The simplest and fastest way to detect SARS-CoV-2 positivity is the iHealth COVID-19 Antigen Rapid Test which gives super fast results in just 15 minutes. It detects presence of SARS-CoV-2 nucleocapsid protein antigen which can be collected non-invasively, without causing any discomfort. It only takes 4 steps and 15 minutes to complete the test! This Covid Rapid Test kit is a perfect fit for keeping your health in check on a regular basis as it fits your time and budget quite efficiently.

Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen 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.. Easy to use & quick - zero discomfort Rapid Covid Test iHealth has completed testing on several heat inactivated variant strains and the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations 2 Test Per Box Non-Returnable Item. 2 COVID-19 Test Cards 2 Nasal Swabs 2 Tubes User manual for the Covid Test Kit. 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.. iHealth has completed testing on several heat inactivated variant strains and the iHealth® COVID-19 Antigen Rapid Test was able to detect the mutations.. 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.. Indicaid Covid 19 Antigen Rapid Test - 25 Count. The INDICAID™ COVID-19 Rapid Antigen Test is

Multiple COVID-19 home tests have been recalled. Here's a list of which ones to avoid, and which are still authorized by the FDA.

To that end, the FDA continues to issue recalls for certain at-home COVID-19 tests —the most recent one being SD Biosensor Inc.'s STANDARD Q COVID-19 Ag Home Test.. The company issued a voluntary recall of their at-home test on January 31, following reports that the test kits were illegally imported into the US, the FDA said .. The STANDARD Q COVID-19 Ag Home Test is only one of multiple at-home tests that have been recalled lately.. The Centers for Disease Control and Prevention says COVID-19 tests can generally be divided into two camps: rapid antigen tests, which give you results within a few minutes, and molecular tests, which involve you taking a sample and shipping it to a lab for results.. In a safety communication issued January 28, the FDA warned people to stop using Empowered Diagnostics' CovClear COVID-19 Rapid Antigen Test, as well as the company's ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.. Though no adverse health consequences or deaths came from use of the tests, the FDA still urged people to dispose of the tests and ask for a refund.. BinaxNOW COVID-19 Ag Card Home Test BinaxNOW COVID-19 Antigen Self Test BinaxNOW COVID-19 Ag Card 2 Home Test COVID-19 At-Home Test by SD Biosensor, Inc. CLINITEST Rapid COVID-19 Antigen Self-Test iHealth COVID-19 Antigen Rapid Test CareStart COVID-19 Antigen Home Test BD Veritor At-Home COVID-19 Test SCoV-2 Ag Detect Rapid Self-Test by InBios International, Inc. InteliSwab COVID-19 Rapid Test Celltrion DiaTrust COVID-19 Ag Home Test QuickVue At-Home OTC COVID-19 Test Flow flex COVID-19 Antigen Home Test InteliSwab COVID-19 Rapid Test Rx QuickVue At-Home COVID-19 Test Ellume COVID-19 Home Test. Detect Covid-19 Test Lucira CHECK-IT COVID-19 Test Kit Cue COVID-19 Test for Home and Over The Counter Use Lucira COVID-19 All-In-One Test Kit. According to the Federal Trade Commission (FTC), there are a few additional ways to make sure your at-home COVID-19 test is legitimate, like scoping out the seller before you purchase a test (it's best to purchase tests from trusted sources, like pharmacies and retail chains).

At-home COVID tests remain a potent weapon in the pandemic fight but they might not catch early infections.

But new guidance from public health agencies has left some Americans confused about how and when to best test for COVID at home.. Spurred by the availability of free tests from the government and health insurance covering the cost of kits , the use of at-home COVID tests increased dramatically at the start of this year, between the fall of delta and the rise of the omicron variant .. At-home rapid antigen tests can detect the COVID virus without the need of laboratory equipment.. A nasal sample is mixed with a chemical solution that extracts the antigen proteins.. For those exposed to COVID but not showing symptoms, the FDA recommends taking three at-home COVID tests, each also 48 hours apart.. Their study showed that two rapid antigen tests two days apart detected COVID infections 94% of the time in people with symptoms.. For people without symptoms, two at-home tests taken at the same interval detected COVID infections 63% of the time, but a third test increased that percentage to 79%.. The agency no longer suggests quarantine after a COVID-19 exposure.. People can stop masking earlier than 10 days if they received negative results from two rapid antigen tests taken 48 hours apart.. Yes, it seems that at-home COVID tests are as good at detecting the omicron variant of COVID-19 as they were detecting earlier variants like delta.. Omicron variants BA.4 and BA.5 contain most of their mutations on the spike protein, which is not what triggers at-home COVID tests.. If you're not insured or have used up your limit of at-home COVID tests, you may want to try a community health center.

As COVID-19 cases and hospitalizations increase with new infections of the BA.4 and BA.5 variants, experts weigh in on at-home test shelf life.

Though studies regarding the accuracy of at-home tests were performed specifically on previous variants, experts say the sensitivity on the tests should be enough to pick up on BA.4 and BA.5, two highly infectious omicron subvariants currently spreading throughout Ohio and the Cincinnati region.. A study of the effectiveness of BinaxNow, a commonly used at-home rapid antigen test, found that the BinaxNow test accurately registered a positive result in 95% of samples that were also found positive by a polymerase chain reaction (PCR) test.. "Any time you can take an additional step to mitigate the spread, whether it's taking a proactive test before you see someone who's high risk, whether you're coming from a county that has high community spread, we recommend tests for anyone who wants to be cautious and take prevention steps," Carter said.. The risks are that the tests can become dried out and over time and won't give an accurate test result.. If you are immunocompromised or high risk for severe disease: Wear a mask or respirator that provides you with greater protection; Consider avoiding non-essential indoor activities in public where you could be exposed; Talk to your healthcare provider about whether you need to take other precautions (e.g., testing); Have a plan for rapid testing if needed (e.g., having home tests or access to testing); Talk to your healthcare provider about whether you are a candidate for treatments like oral antivirals, PrEP, and monoclonal antibodies.. To help agencies get a better understanding of community spread, local health departments have asked individuals who do utilize at-home tests, to self report positive tests.. Some tests given through a doctor, clinic, or health department are proctored, meaning a staffer watches the test be administered and the result through a smart phone or app.

All You Need To Know About Home COVID Tests—And How To Get Them For Free

A home COVID test is best for people who want near-immediate results for their COVID infection status.. Once you complete the test instructions, you can find out your status within 15 to 30 minutes.. She says rapid antigen tests can help limit the spread of the virus while you wait for PCR results, which can take days to be processed.. While most home COVID test kits you’ll find contain nasal swabs, you might encounter some that test a saliva sample instead.. Beginning Jan. 15, 2022, insurance companies and group health plans are required to pay for or reimburse insured parties for the cost of at-home COVID tests, according to the U.S. Department of Health and Human Services.. Availability of free at-home COVID tests depends largely on where you live.. If you get a negative result, you may still want to follow up with a PCR test in case you have low levels of the virus load, says Hokeness.. And if you have symptoms that persist after a negative antigen test, it’s prudent to get a PCR test and consult a medical professional.. It’s also best to get a PCR test if you need proof of your negative status, such as for an event, to attend school, to go to work or to travel.

Does Tramadol show up on a drug test? The answer is not so easy, it varies from person to person. There are several things to take into account.

AllWhen going into drug testing you should know does tramadol show up on a drug test and how long the drug can stay in your body, a common misconception is that drugs usually vacate the body quickly.. So if you’re going for a swab test then it’s important to know that even after 48 hour the test can find traces of Tramadol.. Approximately 7% of all people who take Tramadol are slow metabolizers of the drug, meaning it will stay for longer periods of time.. This can further be extended if people take other drugs that further slow down their metabolism.. The risk of impaired kidneys or liver function can also further slow down the process.. Dosage – People taking higher doses of Tramadol will have a tough time trying to clear it out of their system, and so the drug will stay on and show up in testing.. Frequency of use – People who take this pain medication more often will have trouble clearing their system as well.. Metabolism – A slower metabolism in general means that drugs that have come into your system will take some time to leave it.. The best way to make sure Tramadol doesn’t show up on testing strips or other types of tests is to stop using the drug for some time.

Videos

1. How to use iHealth COVID-19 Antigen Rapid Test Kit Step 5 - Read your results at 15 mins
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2. How to use the iHealth COVID-19 Antigen Rapid Test
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4. iHealth Covid-19 Antigen Rapid Test Tutorial-Vietnamese
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5. How to use the iHealth COVID-19 Antigen Rapid Test
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6. Tested Myself for COVID Live with iHealth Test Kit
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