Voluntary Recall Notice: On October 1, 2021, Ellume issued a voluntary recall of specific lots of its Ellume COVID-19 Home Test, due to an “increased chance” that tests may provide an incorrect positive result (also known as a false positive). In a safety communication on October 5, 2021, the U.S. Food and Drug Administration (FDA) confirmed this issue was “due to a recently identified manufacturing issue” and that “negative results do not appear to be affected by the manufacturing issue.” To see if your Ellume COVID-19 Home Test is included in the product recall, compare the lot number on the test carton to the lot numbers on Ellume’s website. If you have unused tests from an affected lot, you can request a product replacement via ellumecovidtest.com/return.
In more than 18 months of COVID tests and scares, toilet paper hoarding, lockdowns, vaccines, and cautiously optimistic travel, I had never had a family member test positive for COVID—until my two-year-old daughter got a positive result from an at-home antigen test last month.
It was the evening before we were supposed to fly to Los Angeles to visit family we hadn’t seen since February 2020. We had all agreed to test the unvaccinated kids (all the adults were fully vaxxed) just to be on the safe side. Up popped the result on my smartphone, and 24 hours of straight panic ensued, marked by a trip to a nearby clinic for a follow-up PCR test, a sleepless night waiting for the results, and lots of creepy parental stares as we studied our daughter for any hint of a symptom (she had none).
Despite suspecting it was a false positive result—and knowing that children have fared better in the pandemic than adults—it didn’t stop my stomach from churning. Could it be the Delta variant? Would we have to cancel our trip? Would we all need to get tested, or risk bringing it across the country? Most importantly: Was my kiddo OK?
Thankfully, the PCR test came back negative that morning, and our trip was on, despite a few new gray hairs. But I did wonder: What if we had been abroad? U.S. citizens are required to show proof of a negative COVID test (antigen or PCR) before boarding a plane home, and the CDC only recently approved home COVID tests with video proctoring as a suitable re-entry plan. If you travel with these tests and don’t pack backups, what do you do?
I put all my hand-wringing questions to another parent (of three boys), Dr. Sean Parsons, the founder and CEO of Ellume, an Australia-based digital diagnostics company that was the first to market with a COVID-19 home test. (The company has since partnered with Alaska Airlines and Delta Air Lines to give passengers easy access to home antigen tests.) Ellume was the test we had used before flying to L.A.—it’s a 15-minute process that promises results for both asymptomatic and symptomatic cases, for ages two and up. Despite the false positive, I would use Ellume again, especially after our conversation.
The following interview has been edited and condensed for clarity.
Can we talk a little bit about false positives and how you might handle that if you’re abroad?
First of all, I’m sorry to hear you had a false positive with our test. I’m sure that was a stressful thing for you and for the family. We at Ellume fully recognize the impact these results have on people, and so I’m sorry about that. All of the antigen tests have some level of false positive rate. When we developed the product . . . we were being very deliberate about chasing positives. We wanted to catch every single positive we possibly could. It becomes a tradeoff—you can win more positives, but you’re going to pick up a few more false positives as a part of that.
That meant that in the clinical trial, we had about 3 percent false positives. We were a little surprised by that. We really target 99 percent [correctly identified positive results]; nevertheless, we felt that the goal was to get out and catch these positive cases.
If we’re thinking about the adverse outcomes for people, a false positive is really frustrating, and worrying, and anxiety provoking; a false negative is genuinely dangerous. So we said we’ll chase the positives pretty hard. . . . If you take our test and it’s negative, you can be pretty darn sure that you’re negative.
Now, when we developed the test, we hadn’t really imagined the travel scenario in depth—the whole use for people going overseas and returning to America. In that scenario, it’s even more painful, and anxiety provoking, and worrisome for folks to get that false positive. So we’re strongly recommending that people take another test with them. ... And with Azova, who are there as the proctors of the test, they have a network internationally of places to go and get a lab test.
[Editor’s note: Ellume also recommends you leave enough time to get a second confirmatory test before your flight, and download the app while you’re still in the U.S. To re-enter the U.S., you have to show a negative test, so consider getting travel insurance that covers epidemics in case you do get sick.]
I did wonder about using home COVID tests on two- year-olds (the cutoff age). Is there something about a two-year-old’s biology or a baby’s biology that makes this test less accurate?
[It’s less the baby’s biology, and more the biology of the disease.] The background story to all of this is that we spent a decade, from 2010 to 2020, creating a home flu test. That’s how we were the first ones to get a home COVID test through, because the FDA knew all about our technology from the work we’d been doing. As a company, we’re already looking to combine our flu assets with our COVID assets to make a combined COVID/flu test, which is the natural progression.
Flu is a bit different to COVID in terms of the impact on young people. Infants, small children, are at higher risk of severe disease and death from flu than they are from COVID. When we developed the product, we said, if you’ve got a really little kid, less than two, and you think they’ve got the flu, we think you should see a doctor. We didn’t want someone coming in with a six-week-old baby who got the flu from a sibling, and they do a test, and the parents think they’ve got this covered, rather than getting clinical care from the beginning. So we set our threshold at two [for the flu test and the COVID test]; we felt that was the age above which it made sense for parents. Trying to swab a two-year-old is no easy thing, which I’m sure you found out. They don’t like it much at all and they’re surprisingly strong when they put their mind to it.
If you can account for the flu with a home test, how hard is it to account for the variants—the Deltas and Lambdas?
We won’t easily be able to detect the variants of COVID. We won’t be able to say you’ve got Delta, you’ve got Lambda, you’ve got Alpha. The protein we detect isn’t really changing between the variants. We detect the protein that replicates the viral RNA when it hijacks your cells
This is going to be an ongoing thing as this virus evolves and mutates, and we figure out what we have to do on the vaccine front to cover the main bases until this all subsides. I don’t think it’s going to go away—I just think it’ll bubble in the background. We’re going to get used to that new normal, I think.
Is the new normal constant testing for COVID, or something else?
The real game changer is going to be the drugs. They’re a little bit like flu [meds] with Tamiflu and Xofluza the two big therapies that are out right now. There are going to be time-sensitive therapies, where the sooner you take them, the more effective they are. . . . You know how people will get cold sores and the sooner they put the stuff on their lip for the cold sore, the better the outcome? It’s exactly the same with the flu. The further advanced that disease gets, the harder it is to modify the course of the illness.
When the drugs come for COVID, and there are a couple of pretty serious groups a fair way down the road here, we’re going to find that this is a game changer. The three big groups—Merck in partnership with Ridgeback Bio; Pfizer; and Shionogi, which developed Xofluza—are really muscling up. . . . If you can get tested as soon as you’re symptomatic [and take medicine], you’re going to make a big dent in how this thing affects you personally, but also how much virus you shed.
I do think that from a travel perspective, it’ll be an even bigger deal. I think traveling with a couple kits of drugs and a couple of tests is going to be part of [our] approach. Engaging with healthcare authorities as an international traveler can be difficult and expensive. It’s kind of why some people go traveling with their pillbox, right? They get their antibiotics before they go. They recognize they’ll self-manage to the greatest extent possible. I think we’ll find the same thing will happen with COVID in the future.
Ellume COVID-19 Home Test with Azova
Buy now: $50 for test kit and video observation required for international travel, azova.com; $39 for test kit only, amazon.com (video observation must be scheduled separately through azova.com and costs an additional $15)
This article was originally published on August 12, 2021; it was updated with new information on October 6, 2021.