COLUMBIA, S.C. (WIS) – The Food and Drug Administration said the number of rapid COVID tests that Americans can take at home is expected to double in the next several weeks.
The boost will come as the result of the FDA granting emergency use authorization to a new test, ACON’s Flowflex COVID Home Test, this week.
ACON will manufacture more than 100 million at-home tests per month by the end of the year, and the federal government said about 200 million of these tests will be available by December, which is about quadruple what was available earlier in the year.
“Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests. The FDA considers at-home COVID-19 diagnostic tests to be a high priority and we have continued to prioritize their review given their public health importance,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.
These at-home, rapid tests are available over-the-counter, without a prescription, and people can have results within minutes of a nasal swab.
“If it’s positive, the person can immediately isolate, and that would prevent exposure to others and prevent the possible spread of disease,” DHEC Assistant State Epidemiologist Dr. Jane Kelly said. “The downside is that these tests are not as sensitive as the gold-standard PCR test.”
At-home, rapid tests have been widely available in Europe but harder to find in the U.S.
As opposed to PCR tests, which are typically administered by nurses or medical professionals, the at-home tests can be self-administered.
Doctors said that can lead to mistakes and false results if people don’t carefully follow directions.
“It’s got to be a clean environment, and if you want to test yourself because your spouse just tested positive, and she has coughed all over the little area that you’re putting your test on, you will still measure her positive test result, not yours,” Dr. Helmut Albrecht, an infectious disease doctor with Prisma Health, said.
Albrecht said the rapid tests work best with people who are symptomatic and take the swab in the first four to 10 days of their illness.
“There’s virtually no data on how this testing works in totally asymptomatic folks, so you have to know what you’re doing a little bit,” he said.
Earlier this week, about 200,000 at-home testing kits from Ellume were recalled because some of the tests were throwing false positives.
“It’s better than no test, but it’s not the best test for most patients,” Albrecht said.
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