- FDA authorizes Flowflex, a new at-home rapid COVID-19 test manufactured by California-based ACON Laboratories
- Like other antigen tests, this test identifies a protein on the surface that is coronavirus and provides a test result within minutes.
- This authorization is expected to double the testing capacity at home in the US – adding to other home tests that are in high demand, thanks to Delta
- It could also drive down prices – currently rapid tests are ten times more expensive in the US than in other countries
- By the end of the year, ACON Laboratories aims to produce over 100 million home tests a month, doubling to 200 million tests a month by February 2022.
- Experts say that widely available at-home COVID tests can help in early detection of cases, but people should be educated about how to use the tests properly
Flowflex, a new at-home rapid COVID-19 test manufactured by California-based ACON Laboratories, has received emergency use authorization from the Food and Drug Administration (FDA).
The new authorization is expected to double the rapid testing capacity in the US – adding Abbott Binex Now and other tests that are in high demand and potentially driving down prices.
Rapid tests are currently ten times more expensive in the US than in other countries.
By the end of the year, ACON Laboratories aims to conduct more than 100 million home tests a month – with production capacity increasing to 200 million per month by February 2022.
Experts say that widely available at-home COVID tests could help Americans quickly and easily identify if they have been infected with the virus.
But the Biden administration should educate people on how to properly use these tests, says Scott Baker, CEO of the Association of Public Health Laboratories.
Flowflex, a newly-approved rapid antigen test, is expected to double the supply of at-home COVID tests in the US within weeks. Pictured: A French traveler holds a box with a Flowflex test, at an airport in Lisbon, Portugal, June 2021
More than a year after rapid antigen tests authorized for the first time in the USThe tests have become widely popular as a convenient, fast way to identify COVID cases.
Unlike polymerase chain reaction (PCR) tests, which look for coronavirus DNA in a patient’s nasal swab or saliva sample, antigen tests identify a protein on the surface of the virus.
PCR tests require expensive equipment and trained technicians. Patients often do not get their PCR test results for several days after having a swab.
Antigen tests, on the other hand, return results in 15 minutes – and can be used in homes, schools, and many other settings.
The Binex Now test from Abbott Laboratories is a popular at-home antigen test that can be purchased at American drugstores and ordered online without a prescription.
Case growth driven by the Delta variant has fueled the demand for these tests.
The Biden administration has promised to increase the availability of at-home testing and reduce the prices of tests.
But availability and affordability in the US are still pale in comparison For other parts of the world. Rapid tests are less than $1 each in Germany and about $3.50 in India.
That’s about ten times cheaper than in the US, where two-packs of BinaxNOW tests cost $14 at Walmart or $24 at CVS.
A new rapid testing option, authorized by the FDA on Tuesday, is expected to help meet this demand.
The new test is manufactured by ACON Laboratories, a medical device company based in San Diego, Calif.
This test — called a Flowflex — can be purchased over the counter, as can Abbott Binex Now and other models.
Users can swab themselves with the provided disposable swab, then place the swabbed sample on a small card with the solution provided.
Like other rapid antigen tests, the Flowflex test is designed to be easy to use at home
After a short time, the test card will display a red line for a negative result or two lines for a positive result.
ACON Laboratories expects to produce more than 100 million Flowflex tests a month by the end of 2021.
And by February 2022, the company hopes to increase its production even more — 200 million tests a month.
The FDA estimates that ACON Laboratories’ production will double the supply of home tests in the US in a matter of weeks.
“As a result of this authorization, we will now have millions of additional tests available in the US market,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. told USA TODAY.
The company has not publicly said how much the FlowFlex tests will cost, or where Americans will be able to purchase them.
The test displays one red line for a negative result or two lines for a positive result.
Scott Baker, CEO of the Association of Public Health Laboratories, told Politico that The new testing authority is a ‘really nice surprise’.
However, Baker said the Biden administration and other public health leaders have more work to do in educating Americans about using at-home tests.
‘It’s great to have tools, but also to have a companion PSA or some other public information that talks about when to use them, how to use them and what to do with the results,’ Baker said.
As a downside of their speed and convenience, rapid tests are not as accurate as PCR tests.
Rapid testing is more likely to provide users with a ‘false negative’ – meaning the test provides a negative result even if the patient does, in fact, have a COVID infection.
But experts who specialize in rapid tests, such as epidemiologist Michael Minhave argued that rapid tests are better at identifying who is actively infectious – and capable of spreading the virus to others.
Studies have also shown that rapid tests are better equipped to catch COVID cases when they are used twice within several days or at a regular frequency, such as once a week.
because of this reason,…