By now, you’re confused. The President of the United States is telling you that, “The testing is going very well.” So well that New York City, in an effort to conserve its limited supply of tests, has declared that “providers not test patients unless hospitalization is required,” per a report in Gothamist. Meanwhile, health authorities in California are “frantically” counting the number of coronavirus tests available in the state, “reflecting a lack of both testing kits and crucial medical supplies like masks and gowns to protect health-care workers,” reports the New York Times.
The testing shortage for the novel coronavirus then led to reports of the emergence of “private physicians and ‘concierge’ doctors offering tests to their patients at a price,” according to the L.A. Times. This is how your favorite celebrities and professional athletes — most of whom didn’t show any symptoms — got tested while others of lesser means waited to lose their sense of taste and smell and for their fever to set in.
Worse still is the near-simultaneous opportunity that arose from the testing lag for scammers to prey on the sick and the dying. “On Monday, mycoronavirustestkits.com offered two test kits for $75 and $150 — half-price, according to the site,’ reported NBC News. “The site, which offers few details about its operation or owner, displays a banner reading ‘THE TRUTH WILL SET YOU FREE — JESUS.’” Additionally, CNN reported that scammers were using robocalls to spread disinformation about free at-home coronavirus test kits.
But these were just small-time crooks, attempting to profit off the current administration’s abysmal handling of testing for the coronavirus by scamming your grandmother out of a few hundred bucks with medical-grade nasal swabs and a plastic test tube. Far more menacing, the hounds of big tech — gleaning an unprecedented opportunity to formulate their latest marketing initiative from the testing hysteria — began to mount their calculated media assault. Last week, Business Insider reported, “A San Francisco startup is shipping coronavirus home test kits to sick Californians for $167.” The day before, Fierce Healthcare ran a similar headline regarding the imminent introduction of at-home test kits. Similarly, TechCrunch reported more of the same giddy excitement for a big-tech solution to quell our national anxiety by announcing that more “health-care startups roll out at-home COVID-19 test kits.”
And so, amidst the digging of mass graves, the lack of burial space and an utter lack of leadership, the story quickly became that, all thanks to the altruistic genius of Silicon Valley — our real-life Marvel Universe — humanity may have a fighting chance. The messaging from their blogs was such that in a matter of weeks, days, even hours, ordering an at-home coronavirus test kit will be as easy as one, two, download an app.
There was just one nano-size problem: These tests aren’t quite real, either. On Monday, the New York Times reported that the Food and Drug Administration “issued an alert warning consumers that it had ‘not authorized any test’ for the coronavirus that people could buy and administer at home.” Carbon Health and Nurx — two of the online healthcare companies that had begun shipping at-home test kits to the first wave of customers — suspended sales of their kits. As such, if you woke up early Monday morning to purchase one of these tests from Nurx’s website, you were met with this message: “We have paused new test requests. Please check back often for updates.”
This, insists Allison Hoffman, communications director at Nurx, has nothing to do with the quality of their at-home test kits and more to do with the FDA’s approval processes. “I do want to emphasize, however, that neither Nurx nor our partner lab have reason to doubt the accuracy of our COVID-19 self-collection test, given the sensitivity and specificity data collected to date,” she writes over email. The suggestion here, of course, is that the problem isn’t the for-profit online health-care companies, but instead the FDA’s red tape.
Even if they were still available, however, these at-home test kits are no silver bullet against coronavirus. According to Sheldon Campbell, associate professor of laboratory medicine at Yale and director of clinical laboratories for the VA Connecticut Healthcare System, “at-home testing is a weird, peculiar offshoot of testing in general.” “It’s probably better to call it at-home specimen collection instead of at-home testing, because nobody’s going to do one of these ‘tests’ at home for the foreseeable future unless they’re a molecular biologist who sets it up at home for their own use, and that would be unusual, to say the least.”
Along these lines, Campbell isn’t convinced that most people are aware just how invasive this type of collection can be. He refers me to a 41-second video on YouTube from the New England Journal of Medicine called: “NEJM Procedure: Collection of Nasopharyngeal Specimens with the Swab Technique.” In it, a fully gloved hand inserts what appears to be four inches of a six-inch swab into the nose and through the nasal passage of a woman who appears noticeably uncomfortable as the end of the swab inches ever closer to her brain — think the bug-extraction scene from Total Recall and you’re not far off.
The video illustrates a method of specimen collection that’s used in PCR (polymerase chain reaction) testing — the type that was being marketed by online healthcare providers like Nurx, Carbon Health and EverlyWell. The PCR test is looking for the viral RNA, explains biochemist Curtis Schneider, “which is good,” he says. “If you have the infection, it lodges in your nasal cavities and your respiratory tract — those are the most common places that it gets locked in and it starts replicating there. So before you even get a runny nose before your immune system kicks in, any of those immune responses that give you all of those symptoms, the viral RNA is still there and replicating.”
But obviously, all of that depends on how accurately and responsibly a person can conduct the specimen collection. “Okay, so could you do that to yourself?” Campbell says after waiting for me to watch the video. “And if you had someone else do it for you, would you probably sneeze on them and give them whatever you had? That’s a big part of the FDA’s concern.”
To his point, in the third comment for the YouTube video, someone who claims to have had their nasal passage swabbed notes, “She [the woman in the video] took that like a champ. I instinctively kept grabbing my nurse’s wrist to stop her.” Others, too, wrote that they were “sneezing” and “crying” the whole time. Which speaks to yet another of Campbell’s concerns: Who would actually get tested this way? “Will we test people who are sick, or will we test people who aren’t sick and don’t really need a test at this point?” he asks. “And if you’re not sick but you got exposed yesterday, you definitely don’t need a test because you almost certainly won’t be positive whether you’ve got the disease or not. People only turn positive with the test a couple of days before they become symptomatic, and people don’t become symptomatic for four to ten or more days after they’re exposed.” In other words, if you get tested the day after you’re exposed, your test will report a false negative.
“There isn’t a test for [finding] incubating COVID-19,” Campbell adds. Not to mention, it’s the delays in the PCR model — a day to ship out the kit and a day to ship it back, then getting your results four days later — that have potentially lethal side effects. “You’re negative, and you say, ‘Okay cool, I don’t have it,’” says Campbell. “Except that you were incubating it four days ago. And now that you’re actually infectious and getting ready to crash, you’re going to give it to your mother, who you went to see because you’ve got a negative test.”
And again, it takes skill and doing everything in the right order and in the right proportions for a PCR test to provide an accurate result, “Because RNA, the genome of the virus, falls apart easily,” says Campbell. “Everything in the world chews up RNA, so the virus has to be kept pretty well intact. That’s why we have these special collection devices, which are in shortage.”
There is, however, an alternative form of at-home coronavirus test-kit currently in development by Scanwell Health — another medical testing kit company — that uses a serological approach (a blood sample) that looks for the presence of antibodies. “This is still pending FDA approval, and the company [Scanwell] is seeking that under the emergency use authorization, with an anticipated approval process time of around six to eight weeks,” reports TechCrunch.
Campbell says that the process of this test — which is a combination of a finger stick test for glucose and a pregnancy test — is the more feasible approach to any at-home specimen collection and subsequent test. “However, it’s not a great test for diagnosing COVID-19,” he says. “It isn’t terribly sensitive when people first get sick and are shedding the virus. It turns positive by a week or so thereafter, pretty reliably. But it’s not a particularly good acute diagnostic.”
Not only does this type of test render a higher percentage of false negatives, but the technology it uses — that’s being marketed by these online healthcare companies as state-of-the-art — is, according to Schneider, at least a decade old. “They’re just making a blood collection device and a supply chain service,” says Schneider. “So I don’t know that it’s a big jump in technology.” He points to companies that offer similar at-home testing, like the 23andMe genetic testing model. “You’re collecting a sample and shipping it to the centralized lab, but we don’t have the infrastructure necessary to support a bunch of extra samples being piled onto our public health and hospital laboratories,” says Schneider. “The companies that are working on getting that sample collection at home, their technology is really the collection device and a cell phone app to track your results. That’s not really developing any form of a test for SARS-CoV-2 at all. It’s all about giving people the warm fuzzies with the right colors.”
Instead, he says, the only thing these companies are doing is applying a technology solution to a perceived supply chain limitation. “Some of those companies set up their own centralized laboratories, but it’s not doing anything with the testing that makes it easier and generally more accessible,” he says. “They’re just running another clinical laboratory, which taps into the same clinical laboratory scientists and the same lab directors and the same pool of MDs that every clinical lab currently taps in to.”
Which is a problem considering everything, including the necessary lab materials needed to process these at-home specimen samples in a lab, is currently in grave shortage. “The companies that have gotten FDA-approved tests — Roche, Cepheid and three or four others — are all allocating the number of their reagents [substances added to spur a chemical reaction] and their cartridges that they have gotten approved for,” explains Campbell. Put bluntly, he continues, “The labs that at-home startups are working with are taking resources from labs doing more effective testing models. I’m sure that’s something else that the FDA thinks about.”
As things currently stand, there are still no FDA-approved at-home test kits. The closest model to getting FDA approval — which again, is still six to eight weeks away — is Scanwell’s serological at-home test kits, but they’re not going to do the job required of them. “My question becomes, how useful and actionable is that information for people to actually work on?” says Schneider. “It’s not catching you pre-infection or pre-symptoms. By the time you’re expressing enough antibody to be detected by that test, you’re symptomatic.”
It’s a nice way of saying that the bulk of these online health-care providers offering supposed state-of-the-art, tech-driven solutions for mitigating the coronavirus testing catastrophe are nothing more than today’s snake oil salesmen.
Isn’t the future great?