At the start of the COVID-19 pandemic, not nearly enough Americans were being tested for the coronavirus disease (COVID-19). This was largely due to a shortage of diagnostic testing capabilities. And while testing supply eventually ramped up, shortages continue to occur with regional increase in demand. However, tracing infected individuals was and continues to be an important step in preventing new infections.

Now, as the Omicron variant is dominating the COVID-19 landscape, at-home test kits are in high-demand. These are tests that anyone can order and complete without physically visiting a provider. A number of companies are selling at-home tests authorized by the FDA. Here’s what you need to know about at-home test kits. 

Are at-home COVID-19 tests authorized by the FDA?

The FDA has authorized at-home COVID-19 tests under an Emergency Use Authorization (EUA). Receiving an EUA does not mean that the product is officially FDA-approved. It’s an authorization that allows unapproved products to be used during the public health crisis. Several testing companies including Amazon (iHealth) and LabCorp (Pixel) obtained an EUA for their own at-home COVID-19 tests.

Others like Vault, Vitagene, and hims & hers are all selling an FDA -authorized test developed by RUCDR Infinite Biologics.

Some at-home tests are authorized for at-home collection only. This means you’ll collect a sample and mail it to a lab for your results. Others are authorized to be used completely at home (sometimes called self-tests). This means you’ll collect your sample and perform the test yourself at home.

The National Institute of Health (NIH) and the FDA are working together to be able to bring more tests to market faster. These two organizations working together will streamline the approval process so more companies can manufacture test kits and get more kits on the shelves sooner.

How do coronavirus home test kits work?

There are two types of at-home tests for COVID-19: molecular (PCR) and antigen tests. They work differently to confirm if you’re infected with SARS-CoV-2, the virus that causes COVID-19.

Molecular tests will detect if SARS-CoV-2 genetic material is found in yoursample. Antigen tests are aimed at detecting specific proteins found on the surface of the virus. More information about the different types of COVID-19 tests available can be found here. 

PCR tests:

FDA-authorized at-home collection COVID-19 PCR tests are available from a number of companies. These tests are not included in the Biden-Harris reimbursement plan.

At-home collection PCR tests generally require you to complete some type of questionnaire or online consultation to assess your COVID-19 risk first. Then you will be sent a test along with instructions on how to collect a sample. The sample is generally collected via a nasal swab or by spitting into a vial and sent to a lab. A provider from the company will follow-up with results and next steps 1-2 days after the sample is received through an app, email, or by phone.

While many at-home PCR tests require sample processing at a lab, there are also a few fully at-home rapid PCR tests. These tests are different from the ones above because you perform the test yourself and get your results in 30 minutes or less. Examples include the Cue COVID-19 test and the Lucira Check It COVID-19 test.

Antigen tests:

Rapid antigen tests are available over-the-counter, such as iHealth from Amazon and BinaxNOW from Abbott. Some people may have to pay for their tests up-front and submit a claim for reimbursement while others will be able to get their test directly from the retailer at no cost.

Just like the PCR test, you’ll use a nasal swab to collect your sample. From there you’ll expose the swab to the included chemicals and await your results. You won’t have to wait long, just 10 to 15 minutes. The tests are pretty simple but you’ll want to follow the manufacturer instructions exactly to get the most accurate results. 

How accurate are coronavirus home tests?

The foundation of any diagnostic test is its accuracy. In fact, the FDA provides recommendations for the test validation in its EUA policy, emphasizing that “false results can have broad public health impact.” The FDA stated that they worked with LabCorp to ensure that data from at-home sample collection is as safe and as accurate as collection in a doctor’s office, hospital, or other testing site.

Everlywell used data from other studies that demonstrated stability of testing samples during shipping. Vault claims that their test is very sensitive for the presence of SARS-CoV-2, with only 1% of tests providing an inconclusive result.

PCR tests replicate parts of the virus so they’re able to detect small amounts of virus in your system. This makes them less likely to turn out a false negative and more accurate for asymptomatic people and people in the earlier stages of the virus. But you’re also more likely to continue testing positive for awhile after you’ve recovered.

Antigen tests have lower sensitivity rates than PCR. Though the individual manufacturers may report higher rates, one review of 64 studies revealed that antigen tests correctly diagnosed COVID-19 infection in 72% of people. Antigen tests aren’t able to pick up on smaller amounts of virus.So, they’re most accurate when people have symptoms and when viral load is at its highest. This is typically within the first week of symptoms. The lower sensitivity rates with antigen tests means false negatives are more likely with them.

While many of the companies are claiming high accuracy, it is important to remember that the tests are only FDA authorized and not FDA approved. Therefore, the tests are only authorized for the duration of the public health emergency, and have not been put through the same type of rigorous review that the agency normally conducts. To get a better understanding on what lab test accuracy really means, check out this article.

Test accuracy is one of the many standards the FDA is reviewing as part of the EUA application. A list of all diagnostic tests beyond at-home tests authorized under the FDA EUA is available here.

Are coronavirus at-home tests available in all states yet?

Test availability seems to be a problem in most states. While at-home test kits are legal and valid in all states, the recent surge of the Omicron variant has increased demand making it difficult for people to find them.

The Biden-Harris Administration is working to help this. Via the American Rescue Plan, the Administration’s goal is to reduce costs of tests, increase access to tests, and get more tests to market. As more manufacturers get FDA authorization, more tests will become available. You can also order at-home tests from the government here. 

Is at-home coronavirus testing covered by insurance?

As of January 15, 2022 insurance companies are required to cover the cost of over-the-counter, FDA-authorized, at-home COVID-19 tests. The government is incentivizing insurance companies to cover the cost up-front when you buy the test which makes the whole process a lot easier. If your insurance company doesn’t cover the cost up-front, you’ll need to submit your receipt and possibly more to get reimbursed.

PCR tests are generally covered by insurance when they are considered medically necessary. This means they won’t be covered for travel or return to school. All plans are different though so check with your plan to see what tests they cover and how.

What other ways can I assess if I have COVID-19?

Self-assessment guidelines provided by the CDC that can be found here. You can also see an online doctor if you have concerns about your symptoms and want to know more about what to do next.

If you feel that you need to be tested or are told to do so, the CDC recommends that you call your local or state health department or medical provider first. While testing supplies are increasing, it may still be difficult to find a place to get tested.

The bottom line:

COVID-19 testing has become an important part of protecting yourself and others from the spread of COVID-19. At-home tests make testing a lot more convenient for many of us, as long as you can find one.

References:

Brennan, Z. (2020). Why FDA’s issuance of EUAs are not ‘approvals’ and why that matters.

Buchanan, L., et al. (2020). U.S. lags in coronavirus testing after slow response to outbreak. The New York Times.