Great news: the US Food and Drug Administration (FDA) has approved its first over-the-counter, totally at-home test. Unlike previously authorized models, the Ellume COVID-19 Home Test requires neither a laboratory to process results, nor a health worker to facilitate, nor a prescription to purchase. Using an accompanying app that provides instructions and displays results, anyone can test themselves for Covid-19 and know their status in 15 to 20 minutes.
In terms of convenience, the Ellume test is difficult to beat, similar functionally to a home pregnancy test. Technically, it is a rapid antigen laminar flow test—a mouthful of a term that means the kit comes with a swab, a dropper, and a tiny capsule of processing fluid. After swabbing their tonsils, the user is instructed to mix their sample into the fluid for 15 seconds. An analyzer with Bluetooth capability, also included in the kit, scans the sample and sends the results to the user’s phone and, if a country’s infrastructure allows it, relevant health authorities.
The BinaxNOW COVID-19 Ag Card Home Test created by Abbott Laboratories, also FDA-approved quite recently, deploys a similar technology, but like the Lucira Health home testing kit—the very first of the bunch to receive emergency authorization—requires a prescription and supervision from a health provider.
How accurate is the Ellume test? That depends. A study that compared the home test with a standard PCR test on about 200 people found it correctly identified 96 percent of the positive cases and 100 percent of the negative—but only in those with symptoms. In those without, the number of correctly identified positives fell to 91 percent.
Like the vast majority of rapid tests, then, the Ellume home test isn’t as sensitive as its PCR counterpart. Epidemiologists like Michael Mina have argued, however, that from a public health perspective high sensitivity isn’t necessarily a dealbreaker. When containing disease at the population level, what matters significantly more is frequency and volume—that more people can get tested more often. What I personally recommend to those who fear the ramifications of a false positive is, after testing positive initially, an immediate second test. This would, per a back-of-the-envelope calculation, reduce your chances almost a hundredfold, from 4 in 100 to 16 in 10,000.
It follows that the bigger issue with the Ellume test and others like it isn’t convenience or sensitivity, but cost. The first kits, due to go out next month, will sell for about $30 a pop at your local pharmacy. The Abbott home tests, at $25 each, aren’t much better, and the $50 Lucira Health tests even worse. For many working families across the United States, especially those with children, these costs are nothing short of prohibitive. Ellume has said that it plans to pump out about 20 million of its Covid-19 home tests in the coming months. For Abbott, that number is 30 million. But it is difficult to imagine these tests making much of a difference if the people who need them most can’t afford them.
The cost of a home pregnancy test Free On Board (FOB), which is to say the price point after factoring in manufacturing and shipping, is 79 cents, and less than 10 million pregnancy tests were used by women in the United States this year. Home Covid-19 tests, if made in batches of hundreds of millions, could potentially be priced at less than 50 cents—comparable to the cost of rapid hepatitis C tests in Egypt, which were used to screen more than 60 million people and, with follow-up treatment, effectively eliminate the disease. I would go so far as to urge state and federal governments to step up and provide Covid-19 home tests in mass quantities for free.
In retrospect, one of the most serious mistakes made this year by world leaders everywhere was to relegate far too little attention and too few resources to testing. Done right, widespread and frequent testing could not only curb infection rates much faster than a vaccine, but also assist vaccination efforts in reducing the threshold for population immunity. The lower the prevalence of disease in a population, the lower the percentage needed to form a bulwark against transmission. Plus, if immunity conferred by Covid-19 vaccines ends up being short-lived, frequent testing would also mitigate the whiplash of subsequent outbreaks, allowing health authorities to isolate and contain them accordingly.
With enough home tests available at a low enough price, parents could test themselves before going to work and their children before going to school. And if home tests were, with federal and state government support, made free to schools and businesses, employers and administrators could get ahead of pending outbreaks and save their staff a whole lot of pain. Frequent testing could even pave the way forward for Covid-19 drug treatments, many of which are more effective when given early on in the disease course—in other words, when someone tests early enough to know they need one.
We have the technology to make the dream of widespread, frequent, and low-cost or even no-cost testing a reality—to flood US households with millions, even hundreds of millions, of home tests per day. What we need are the funds and political will to execute. If we secure both, it won’t be long before we have the momentum we need to wrench ourselves free of this crisis. But if we needlessly delay, we’ll remain down in the muck, too swamped by rising case counts to see the way out.