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Oct. 6, 2021 — Finding an at-home COVID test has been mission impossible for many lately, but that search will soon get easier, thanks to the FDA authorization Monday of a new at-home test and today’s announcement that the federal government will spend another $1 billion to speed up production of these tests.
The White House said it will 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 were Americans can get a COVID-19 test free of charge.
The move, combined with vaccination efforts, will help businesses and schools keep cases down and keep operating safely and smoothly, said Jeff Zients, the White House COVID-19 response coordinator.
“Together, the steps we’re taking will ensure every American, no matter their income level or ZIP code, can access accurate, convenient, and affordable testing,” he said.
The announcement aligns with the administration’s February commitment of $1.6 billion to supply rapid tests to schools and underserved communities.
The increase in access to at-home tests can’t come soon enough. President Joe Biden and his predecessor have both 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 30 authorized in the European Union. Home tests cost more in the U.S., too.
That lack of supply and increased demand can make the search for tests frustrating. I know first-hand. I’m fully vaccinated, but I wanted to test after a recent flight, so I checked for 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 got “out of stock” messages, both online and in the stores. Finally, I found a supply at a CVS about 8 miles away and called to verify. First, I was told they were in stock. But that quickly changed to, “No, sorry, we’re out.”
Then, my nearby Rite Aid said they’d get a supply in 2 days and to show up at 7 a.m. When I did so, the store clerk told me the shipment had not come — and the supplier didn’t call or explain why it didn’t arrive. Finally, another CVS near me said they did indeed have some and would hold two kits for me — their limit per customer. I drove to get them right away. I tested myself twice. Both were negative, thankfully.
New At-Home Test Gets Authorization
The FDA granted an emergency use authorization, or EUA, to a new at-home test, Flowflex. Like other at-home tests, it is an antigen test, which looks for fragments of protein found on or within the virus. It is done, like other tests, by collecting a nasal sample using a swab. But unlike most other at-home tests, the new test is done only once. Others recommend serial testing, with a second test done within 3 days of the first.
By the end of the year, the maker of the new test, Acon Laboratories, says it will produce more than 100 million tests a month. The number will rise to 200 million a month by February, the FDA says.
The new Acon test can be used for self-testing by anyone 14 years or older, and can be done by adults in children as young as 2. Details on costs were not readily available from the company.
White House Pledges More Money
The White House on Wednesday announced another $1 billion investment in at-home rapid tests. In September, the administration pledged $2 billion for home testing.
“It sounds like a significant investment, and I think that’s a good thing,” says Emily Volk, MD, president of the College of American Pathologists and chief medical officer at Baptist Health Floyd in New Albany, IN. While at-home testing can help identify those infected, Volk and others note that it isn’t perfect, as recent FDA safety guidance suggests.
On Tuesday, the FDA announced the recall of one at-home test, the Ellume COVID-19 Home Test. A manufacturing issue resulted in possible false positive results in certain lots of the tests. More information is on the company website about serial numbers and how to tell if your test is included in the recall.
The FDA is working with Ellume to fix the problem.
The affected tests only increased the chance of false positive results, not false negatives.
It’s crucial to follow the instructions on the home tests to the letter, Volk says. For instance, the BinaxNOW test instructs users to put 6 drops of the testing chemicals into a hole on the test card. You then need to swab both nostrils carefully, inserting the swab tip ½ to ¾ of an inch into the nostril and rubbing the swab against the nostril walls, making 5 big circles and swabbing for about 15 seconds on each side.
The swab is then inserted into a hole in the test card, and users wait 15 minutes, but not more than 30, to read the result. Negative results will show one line on the card; positive results have the control line and another line below.
Volk suggests doing the test when there are no distractions from phones, doorbells, pets, or family members. She has used home tests and knows it’s easy to put too many drops of the chemicals, for instance, in the sample.
When choosing a test, she advises making sure the box says the test has the emergency use authorization from the FDA. Pay attention to the instructions about keeping the test at a certain temperature range before use. The test materials should include a toll-free number to get more information or to ask questions.
And, Volk says, if you test negative but still have symptoms, “please go to an accredited lab and get tested with a PCR test.”
These tests, generally viewed as more accurate than the antigen tests, work by detecting genetic material from the virus.
Lindsay Kalter contributed to this report.
Acon Laboratories: “Flowflex COVID-19 Home Test Receives FDA EUA.”
FDA: “Coronavirus (COVID-19) Update: FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers,” “Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue — FDA Safety Communication.”
Emily Volk, MD, president, College of American Pathologists; chief medical officer, Baptist Health Floyd, New Albany, IN.; assistant professor, University of Louisville School of Medicine, Kentucky.
White House: “The Path Out of the Pandemic.”
News briefing, White House COVID-19 Response Team, Oct. 6, 2021.
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