Since the COVID-19 pandemic spread across the globe, science has made great strides, from the rollout of multiple vaccines to the ability for people to now test themselves for the virus at home.
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Adding to that latest accomplishment are the recent emergency use authorizations (EUA) handed out by the U.S. Food and Drug Administration (FDA) for a new group of at-home COVID-19 tests that allow users to get results in 30 minutes or less.
To get a better idea of what you can expect from them, we talked to infectious disease testing expert Gary W. Procop, MD.
Understanding the new round of at-home tests
Dr. Procop and his colleagues reviewed three of the available at-home tests, two of which are only cleared for symptomatic individuals and require a prescription. The third is available over-the-counter (so it doesn’t require a prescription) and is cleared for use by both symptomatic and asymptomatic people.
These tests are essentially home versions of rapid test kits. You collect your own samples and get the results at home. There’s no sending a swab to a lab and waiting days for a result.
These types of at-home tests also make it possible for you to find out if you’re positive for the virus without having to visit a healthcare provider’s office, possibly exposing others.
In most cases, you can get the test from your healthcare provider and you’ll have the option of having them administer the test or taking the test home. These are approved for at-home use by adults, with applications for children varying for the different tests. Once the results are in, the reporting of the results to local health officials also varies by manufacturer, so read the instructions carefully.
But just as with the self-collecting at-home specimen kits, you should have an understanding of how each test works and the pros and cons of the tests.
Isothermal amplification testing
The Lucira COVID-19 All-In-One Test Kit, uses a process called isothermal amplification. It’s a similar process to the polymerase chain reaction (PCR) lab tests that are considered the “gold standard” for COVID-19 testing.
Like the PCR test, an isothermal amplification test makes copies of the genetic material from your self-collected swab, including any viral RNA that may be included, in a process called amplification. By making all these copies, it’s easier for the test to detect any presence of the COVID-19 virus.
There are two big differences between the home version and the laboratory version of this test. First, the laboratory version pulls out that genetic material, including any genetic material of the virus, from the rest of the specimen. Second, while the laboratory version uses heat in the amplification process, the home version uses enzymes for amplification or antigen detection methods.
By removing the genetic extraction and heat from the testing process, Dr. Procop says, this type of testing becomes more doable at home and doesn’t require the more complicated laboratory equipment that’s typically used for laboratory-issued PCR tests.
Two of the at-home tests — one produced by Ellume and the other by Abbott — are antigen detection tests. These tests look for antigens, proteins produced by the virus that prompt a response by the body’s immune system. “It’s the same process used to test for strep throat,” Dr. Procop notes.
Of the two antigen tests, the Ellume test does not require a prescription and has been cleared for use by both symptomatic and asymptomatic individuals. Anyone from the age of two and up can have the test performed, with the test for children being performed by an adult. The test even has its own smartphone app that provides a walk-through on how to collect a specimen with the included swab.
Once collected, the device tests the specimen and delivers results in about 15 minutes to the app by way of a bluetooth connection. One thing to keep in mind: While you have the option of whether or not to share the results with your healthcare provider, the Ellume system does send positive results, along with your age and zip code, to local health officials for the purposes of tracking case rates in your area.
The Abbott test, alternately, requires you to undergo an online screening via the eMed website. If your symptoms meet the necessary requirements, you’ll be shipped a test overnight.
Once the kit arrives, you can log onto the platform and receive a live video walk-through of collection via nasal swab by a guide. This test also comes with its own app that allows you to access test results, which are delivered within 20 minutes. Like the Ellume test, positive results are reported to local health officials for monitoring the spread of the virus.
The pros and cons of at-home tests
There’s a lot to like about these at-home tests. Besides the previously mentioned advantage of keeping potentially infected patients home, there are other positives. They’re relatively affordable, with a price range of $24 to $50. And they should also be relatively easy to obtain, even if a prescription is required.
But you should still keep certain potential drawbacks in mind when thinking about using one of these tests.
Collecting the sample
“One of the issues with these tests can be the quality of the specimen collected by the patient,” Dr. Procop says. “The collection is left to a user who has less experience than a healthcare provider and an incorrectly-collected sample can lead to an incorrect test result.”
While the idea of wiping a swab around the inside of your nose seems simple enough, there are plenty of ways for things to go wrong. It’s very important, Dr. Procop says, for anyone using these tests to follow the included instructions. “The collection is safe to perform yourself,” he says, “it’s just essential that it’s done correctly.”
Overall, the three tests perform quite well with accuracy ratings above 90%. But each has some issues to be aware of.
With the Lucira test, the removal of the genetic extraction step makes the test more convenient for at-home use. The downside, Procop says, is that the genetic material being copied for virus detection by the at-home version isn’t quite as “clean” as with the laboratory version of the test.
“Without the genetic extraction, the specimen contains cellular debris and other biological material that can interfere with the amplification part of the test,” he says.
As for the Ellume and Abbott tests, they are (like healthcare provider-performed rapid antigen tests) slightly less accurate than PCR tests.
“These rapid tests have a tendency to generate some false-positive results in asymptomatic people,” Dr. Procop notes. “So if a person is asymptomatic but has been exposed to someone else who has COVID-19, it can create some confusion as to whether it’s a false-positive or an accurately positive test.”
In that case, he says, additional testing would be needed.
The bottom line: A big step forward, but keep practicing guidelines
These tests and their availability via the FDA’s emergency use authorizations represent a big step forward for COVID-19 testing and prevention. “This means there are now more tests available and there’s a better chance someone who’s infected can more easily isolate thanks to these quick results,” Dr. Procop says.
But, even so, it’s important that everyone continues to follow current CDC guidelines, he says. “Taking precautions – maintaining social distance, frequently washing hands and wearing a mask – are still essential to preventing the spread of COVID-19.”