Since the start of the coronavirus pandemic, health officials have assured us that more tests are on the way. But week after week, it’s become abundantly clear that we still don’t have the number we need to properly assess the spread of the virus.
A few weeks ago, the Food and Drug Administration acknowledged the devastating lag in testing and announced that private companies could begin making their own tests. We’ve since seen an uptick in testing, but the country continues to lack widespread screenings.
To address the lag, at-home COVID-19 test kits have popped up from diagnostic startups like EverlyWell, Nurx, and myLAB Box. But a recent FDA warning advising against the use of at-home tests has left the companies in limbo, and they’re now scrambling to make sense of the new guidelines and figure out how to get the tests to market.
Infectious disease experts say we need to drastically scale up testing to blunt the spread of COVID-19. But are at-home kits the answer?
Here’s how the at-home kits work.
The at-home kits are, in theory, very simple. You sign up online and undergo a screening based on COVID-19 diagnostic guidelines from the Centers for Disease Control and Prevention. If you qualify, a test kit — which costs anywhere from $135 to $190 — is shipped to your home. Then, you open the kit, swab your nose, put it in a vial and overnight it to a certified lab.
The specimen is evaluated and results are sent digitally within a day or two. If you test positive, some companies offer a telehealth session to review your next steps.
Those experiencing more severe symptoms are encouraged to go straight to the emergency room, but for people who develop a more mild illness, the at-home test seems like a good solution.
The folks behind the at-home tests claim they improve access to testing and keep those who would otherwise spread the virus at home. Sheldon Campbell, a professor of laboratory medicine at Yale School of Medicine and associate director of Yale Medicine’s Clinical Microbiology Lab, said the at-home kits may be particularly helpful for people who live in rural areas and have little to no options when it comes to getting tested for COVID-19.
But Campbell, along with other health experts, have a few major concerns about the at-home kits.
It’s not easy for people to swab themselves.
The first red flag, health experts said, is the step where you have to swab yourself.
Swabbing your nasal passage is downright uncomfortable. (If you’ve ever been nasal-swabbed for the flu, you know what I’m talking about. Not fun.) It’s easier when someone else (ideally, a trained health care professional) does this for you, according to Dwayne Breining, the executive director of Northwell Health Labs.
Breining said you have to push the swab brush “into the nose and back toward the ear, as far as you can go back, until you actually hit something” — the back of what’s known as the nasopharynx.
People’s eyes will water, they’ll want to sneeze, fall into a coughing fit, and generally recoil — making it challenging to get a good self-swab.
“Most people won’t have an easy time causing themselves discomfort or pain,” Breining said. Without a good sample from the very back of your nasopharynx, you run the risk of not being able to produce an accurate test. And according to Breining, a good specimen “means everything.”
The specimen could get compromised.
When a test kit travels from point A (your home) to point B (the lab), the room for error is a bit higher. The specimen is typically protected by special gels and packaging, but there’s a risk of interfering with the swab quality.
Campbell said the FDA is now asking the at-home testing companies to run a shipping study to validate the test results and ensure they aren’t affected through shipping.
“These complex laboratory-developed tests are like making a soufflé; everything has to work just right or it falls flat,” Campbell said.
Another concern of Campbell’s: People who actually have COVID-19 may test negative for a period of time after they’re exposed to the virus and before they show symptoms.
“If it takes a day to mail you the swab, a day to mail it back, a day to send it to the lab and a day to test and get the results back to you; how much does that mean for whether you’re infectious now?” Campbell asked.
Because people in this in-between zone are likely to go out and spread the virus to others, Campbell has “real concerns with this approach.”
“These complex laboratory-developed tests are like making a soufflé; everything has to work just right or it falls flat.”
They may provide false negatives and false security.
Due to these issues, test kits — even when conducted in a health care setting — can produce a false negative (or a test that shows a person’s negative for coronavirus when, in fact, they’re positive).
According to Breining, this can happen in up to one-third of all diagnostic test kits. When patients swab themselves, the number of false negatives could easily be higher — and that can put the country in even more danger.
“The consequence [of a false negative] is you end up with a lot of people walking around thinking that they have a negative result,” Breining said. These people would go on spreading the virus with a “false sense of security” that they don’t have the disease, he added.
Breining says he’s very open to the opportunity to get more people tested, but doing it in a way that could potentially give people false results is very dangerous.
“The only thing worse than no answer is the wrong answer,” Campbell said.
At-home diagnostics don’t account for your entire health history.
Another concern is that these diagnostic companies don’t know people’s entire health history. Yes, there may be a screening evaluating a person’s health, but the company cannot get a comprehensive look at a person’s entire health history unless they explicitly share it.
Because so many underlying health conditions ― like hypertension and lung disease ― can increase a person’s risk of COVID-19, it’s critical to have a full, accurate assessment of a person’s health.
“It’s better to have a doctor you know and who knows you order the test and tell you what to do with the results than to have somebody who doesn’t know your medical history tell you from a telehealth script,” Campbell said.
The kits work best when used by a health care professional.
All of this doesn’t mean these tests are entirely a wash. They just probably shouldn’t be used the way they are marketed right now ― meaning on your own.
If they’re done by a health care professional, they actually can be helpful. “The stumbling block is really the specimen quality,” Breining reiterated, and a trained health care professional is more likely to get a good swab.
Everywell has halted the release of its consumer at-home kits and allocated the first batch (of about 30,000 kits) to hospitals and health care systems where trained health care personnel can administer the tests. Ideally, more of the at-home diagnostic labs will follow suit.
If and when people start swabbing themselves, Breining recommended doing it over a telehealth call.
“You could have somebody observing and coaching the patient [virtually] as they take the swab,” he advised. Another solution is to hire a team of health care workers who can go out on the road and collect swabs in person, he suggested.
In the meantime, Breining recommends heading to an in-person testing facility if you suspect you have a severe case of COVID-19.
“You really want to be right at the absolutely highest percentage that you can possibly be,” Breining said. At this point, you’re not going to get that by swabbing yourself at home.
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