A COVID-19 test you can take at home? Lee’s Summit lab joins a growing movement
A Lee’s Summit company is joining a growing field that lets people test themselves for COVID-19 without ever leaving home — part of a movement for better convenience and speed to fight the pandemic.
The at-home test, created by Viracor Eurofins, can be ordered online for $89. Viracor says patients will get results within 24 hours — no more than 48 hours — from the time it receives the sample.
You collect the sample yourself from your nose, rubbing a swab inside both nostrils. The test’s developers say it’s more comfortable than that COVID-19 test you might have had at the doctor’s office or community testing site.
“The kit is designed for individuals with mild symptoms, not severe, so that’s a pretty important distinction,” said Steve Kleiboeker, vice president of research and development for Viracor.
“If you have severe symptoms you should see a physician in a health-care setting. But if you have mild symptoms, or you’ve been exposed to somebody who’s had a recent diagnosis, or if there’s just a lot of spread within your community, those are all reasons to be tested.”
The kit is sold by EmpowerDX, the direct-to-consumer arm of Eurofins, Viracor’s parent company based in Luxembourg. Eurofins’ U.S. labs are doing COVID-19 testing for thousands of clients, from hospitals and doctor’s offices to sports organizations and workplaces. This week Eurofins also launched a new saliva COVID-19 test available to health care providers.
The U.S. Food and Drug Administration granted Eurofins an emergency use authorization for the at-home test. That is not an official approval or clearance. The agency’s emergency process is quicker, designed to meet urgent needs.
Since June, the FDA has authorized about two dozen home collection kits, according to its website.
Eurofins was one of two companies that announced Monday they had received the authorization. California-based biotech company DxTerity Diagnostics also received one for an at-home saliva test.
Accuracy is one standard the FDA uses to review a test before it grants authorization. Though the at-home kits have not been studied extensively, a small Stanford University School of Medicine study found that people can be taught to do their own nasal swabs to get accurate results.
Test samples collected by people who swabbed their own noses “yielded results for the COVID-19 virus that were as accurate as samples collected by a health care worker,” reported the study, published June 12 in the Journal of the American Medical Association.
In another study that confirmed that accuracy, 185 people, most of them health care workers, were tested for COVID-19 in a clinic, then asked to test themselves at home with a nasal swab.
The at-home swabs picked up 80% of the positive cases found in the clinic and as much as 95% of the positive results when the patients had more virus in their nasal cavities. The results were published in a July research letter in the Journal of the American Medical Association.
Nasopharyngeal swabs are considered the gold standard of COVID-19 testing because of their high accuracy rate, but studies show that at-home kits have proven to be nearly as accurate, said Kleiboeker. Not a “new gold standard,” but very close to it, he said.
Here’s how the at-home test developed at the Lee’s Summit labs works.
First, you fill out a questionnaire on the EmpowerDX website. A physician will review it to determine whether you’re eligible for the test, based on Centers for Disease Control and Prevention testing priorities, which include showing symptoms and having close contact with someone infected with COVID-19.
You must be 18 or older and can’t live in a state that prohibits self-collection of COVID-19 samples, so the test isn’t available in New York, New Jersey, Rhode Island and Maryland.
The kit arrives with “what we hope are self-explanatory instructions,” said Kleiboeker. “We did a fair amount of field testing to ensure that the instructions were clear and straightforward to follow.
“It’s a really super easy process. I don’t know if you’ve had a nasopharyngeal swab collected. But those can be a little (uncomfortable). Few people sign up for two of those.”
That method involves having a long swab inserted into the nostril and deep into the space above the roof of the mouth behind the nose. Then it’s slowly rotated as it’s removed to grab the sample.
The at-home kit comes with a similar, Q-tip-looking swab, but it doesn’t have to go in as deep.
“Essentially you rub that around the inside of your nose three times on each side. And you apply a light amount of pressure,” said Kleiboeker. “The Q-tip has to firmly contact your nose, but it should not hurt. It really only tickles, at best.”
You put the swab into a collection tube, place it into a prelabeled, biohazard bag — the feds signed off that it’s safe to transport — and place it in a FedEx drop box on the same day you collect it, before the last express pick up.
Samples should not be placed in drop boxes on Saturday or Sunday and not be taken to a FedEx office, the FDA’s instructions say.
“And then everything past that point is exactly the same as all the standard testing we perform,” said Kleiboeker. “The fact that it’s a nasal swab versus a nasopharyngeal swab doesn’t result in any different type of testing in the lab. It’s just a different source of the sample.”
Since March, Eurofins labs in the United States have ramped up their testing capacity to more than 500,000 samples a week, with a turnaround time for results averaging less then 18 hours from the moment samples arrive in the lab, the company says.
Since the FDA’s authorization was just granted for the at-home kit, Viracor doesn’t “have any real-world experience yet,” Kleiboeker said, on how fast the lab will be able to turn them around.
“But the goal is to have it come out no more than two days after the sample is collected, and ideally more quickly,” he said. “We’ll have some track record and know how we’re doing with that pretty soon.”
Viracor and other labs developing tests are staring down the potentially deadly convergence of influenza and COVID-19 that has bothered health care professionals for months. The hope is that tests with quicker turnarounds will help cut down transmissions.
This story was originally published October 20, 2020 at 10:39 AM.
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