Editor's note: Ellume has voluntarily recalled its COVID-19 home rapid test kit. Some lots of the home rapid tests were found to produce false positive results Read more about the recall on Ellume's website.
In the early days of the pandemic, it was nearly impossible to get a Covid test; in the spring of 2020, health officials told people to assume they were infected with COVID if they felt symptoms and to isolate themselves. Over time, tests became available, but by the end of the year and the beginning of the new year, there were lines of several hours waiting at the testing center in my city.
From the beginning, there was talk of making COVID testing available at home, but this seemed a distant prospect. Instead, the focus was rightly on the development and dissemination of a vaccine.
COVID has not yet completely ended, but the more infectious delta form is still causing a spike in cases in some states. I myself just boarded a plane for the first time since the pandemic began. So easy access to covid testing is as critical as ever. And now I no longer have to go to the pharmacy or doctor's office to get tested.
The $40 Ellume home COVID test (available online and in stores at Amazon and CVS) is the first commercially available rapid home antigen test to receive emergency approval from the FDA. It connects to an app via bluetooth, analyzes nasal swab fluid, and processes the results. Although the packaging does not tout its accuracy, Dr. Sean Parsons, CEO and founder of Ellume, told Tom's Guide that the test is 96% accurate in 15 minutes.
I used Ellume's test the morning after I returned from my trip. Here are the results.
When I opened the Ellume box, I found four components: an analyzer, a nasal swab with an adapter for children, a dropper, and a vial of treatment solution. All parts were packaged separately, sealed, and designed for one-time use. The box also contained an information package and a quick guide.
To use the test, I first downloaded the Ellume app to my iPhone (available in both the Apple and Google Play stores). Before taking the test, the app prompted me to answer some basic information. The app then played a brief video explaining the process. Only after the video was over was I able to begin the actual test.
The app guided me through each step. First, the analyzer was connected to the iPhone via Bluetooth. Next, a vial containing the treatment solution was emptied into a dropper. Next, a cotton swab was placed on the nose (both nostrils) and screwed firmly onto the dropper. The dropper cap was opened and five drops of the treatment solution were dropped into the small hole of the analyzer.
The app then began processing and a 15-minute countdown began until the results were available. The app indicated that my test was negative.
The entire testing process was straightforward, aside from the discomfort of wiping my nose. But the instructions were clear, the app worked seamlessly, and I felt confident in my results. And since each kit retails for less than $40 (currently available on Amazon), even if I were to test for several days in a row, I wouldn't have to shell out the money myself.
Parsons explained that the seed for Elume's home COVID test was planted more than a decade ago, during the 2009 swine flu pandemic. The company saw a need for a rapid test that did not require going through a lab. Then, as technology advanced dramatically with smartphones, Ellume set about integrating its diagnostic technology with smart devices. The result was a patented detection method that uses proprietary fluorescent nanoparticles and a sophisticated reader system.
Still, Parsons and his team did not want to just "bolt on an app that takes pictures of inspection strips. What we did was go further than that. We created a fully integrated instrument," he said. And what we arrived at was a fully digital analyzer with Bluetooth connectivity."
The analyzer looks unassuming, but "there is so much electronics used to make this simple: ...... There is a bunch of firmware that is on disposable cartridges."
But the most important aspect of the home inspection was to make it easy for anyone to use. This meant creating proper instructions to minimize human error. Other rapid tests rely heavily on proper consumer use, which can result in false negatives.
Also, despite its high accuracy of 96%, Elm recommends that anyone with a positive result consult a physician.
The pandemic is certainly not over yet, and Parsons cited the coming winter as a time when testing is still essential.
"The U.S. is doing spectacularly well with vaccines, and the trajectory is impressive. But when the next winter comes, we're going to see a lot of people getting colds and coughs and flu again," he said. And the question will be, "Is this COVID?" the question will arise."
As he points out, many people have not yet been vaccinated and may not choose to be in the future. Parsons adds, "COVID transmission is still going on." And there are still a lot of people who, for whatever reason, want to use our tests as a means of proving that they are not infected with COVID." It's to get on a plane overseas, or to visit family, or some other reason."
I myself tested myself after my trip using some of the samples I received. This seems like an ideal scenario for testing at home. In fact, Delta recently partnered with Ellume to provide kits for international travelers.
The technology developed for home COVID testing could be applied to other diagnostics as well; Ellume is working on a home flu test and plans to follow with a streptococcal test.
And beyond that, the possibilities are manifold. We see the convergence of technology and biology as a big part of the future." The future of health care is putting these tools into the hands of consumers."
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