October 6, 2021 — Finding a home COVID-19 test has been an impossible task for many lately, but that search will get easier soon, thanks to Monday’s FDA authorization of a new home test and today’s announcement that the federal government will spend another billion dollars to speed production of these tests.
The White House said it would also double the number of pharmacy locations in the federal government’s free testing program to 20,000. With the number of community-based free testing sites, that would make 30,000 locations where Americans can get a free COVID-19 test.
Jeff Zentes, the White House COVID-19 response coordinator, said the move, along with vaccination efforts, will help businesses and schools keep cases low and continue to operate safely and smoothly.
“The steps we are taking together will ensure that every American, regardless of their income level or ZIP code, has access to accurate, convenient and affordable testing,” he said.
The announcement is in line with the administration’s commitment in February of $1.6 billion to provide rapid testing to underserved schools and communities.
The increase in access to testing at home cannot come soon enough. President Joe Biden and his predecessor have been criticized for the lack of authorized COVID-19 tests compared to other developed countries. There are barely a half dozen approved for use in the United States, compared to the 30 authorized in the European Union. Home tests cost more in the US, too.
This lack of supply and increased demand can make the search for tests frustrating. I know firsthand. I was fully vaccinated, but wanted to take the test after a recent flight, so I checked the tests online at Amazon and at CVS, Walgreens, and Rite Aid stores in my area, 10 miles from downtown Los Angeles.
Time after time, I get “out of stock” messages, both online and in stores. Finally, I found a supply at CVS about 8 miles away and called to check. First, I was told they are in stock. But that soon changed to “No, sorry, we’re out.”
Then, the Rite Aid next door told me they would have supplies in a couple of days and would show up at 7 AM. And when I did, the store clerk told me the shipment hadn’t arrived – the supplier didn’t call or explain why. it did not arrive. Finally, another CVS close to me said they already had some and would keep two sets for me – max per customer. I drove to take them right away. I tested myself twice. Both were negative, fortunately.
New home test gets permission
The U.S. Food and Drug Administration (FDA) has granted an emergency use authorization, or EUA, for a new home test, Flowflex. Like other home tests, it’s an antigen test, looking for bits of a protein that’s in or inside the virus. It is performed, like other tests, by collecting a sample from the nose with a swab. But unlike most other home tests, the new test is only done once. Others recommend serial testing, with a second test within 3 days of the first.
By the end of the year, the manufacturer of the new test, Eikon Laboratories, says it will produce more than 100 million tests per month. The FDA says the number will rise to 200 million per month by February.
The new Acon self-test can be used by anyone 14 years of age or older, and can be performed by adults in children up to age 2. Details of costs were not readily available from the company.
White House pledges more money
On Wednesday, the White House announced an investment of another $1 billion in rapid in-house testing. In September, the administration pledged $2 billion for home testing.
“It seems like a great investment, and I think that’s a good thing,” says Emily Falk, MD, president of the College of American Pathologists and chief medical officer of Baptist Health Floyd in New Albany, Indiana. While at-home testing can help identify infected people, Falk and others note that it’s not ideal, recent safety guidelines from the U.S. Food and Drug Administration suggest.
On Tuesday, the US Food and Drug Administration (FDA) announced the recall of one home test, the Ellume COVID-19 Home Test. The manufacturing problem has led to possible false positives in many tests. More information is available on the company’s website about serial numbers and how to find out if your test is included in the recall.
The Food and Drug Administration is working with Ellume to fix the problem.
Affected tests increased the chance of false-positive results, not false-negative results.
It’s important to follow the instructions given in the home tests to the letter, Falk says. For example, the BinaxNOW test instructs users to place 6 drops of test chemicals into a slot on the test card. Then you need to carefully wipe both nostrils, insert the tip of the swab to an inch in the nostril and rub the swab against the walls of the nostril, making 5 large circles and wiping for 15 seconds on each side.
The swab is then inserted into a slot in the test card, and users wait 15 minutes, but no more than 30, for the result to be read. Negative results will appear one line on the card; Positive results have a control line and another line below.
Falk suggests taking the test when there aren’t any distractions from phones, doorbells, pets or family members. I’ve used home tests and learn that it’s easy to put a lot of droplets of chemicals, for example, in the sample.
When choosing a test, she advises making sure the box says the test has an emergency use authorization from the Food and Drug Administration. Pay attention to the instructions for keeping the test within a certain temperature range before use. Test materials should include a toll-free number to get more information or to ask questions.
As Falk says, if the test is negative but you still have symptoms, “please go to an accredited laboratory and get a PCR test done.”
These tests, which are generally seen as more accurate than antigen tests, work by detecting the genetic material of the virus.
Lindsey Calter contributed to this report.