First COVID and flu at-home take a look at OK’d by Meals and Drug Administration
Now that we have all been skilled on doing nostril swabs for COVID-19 checks, we’ll quickly have the choice to take a look at for the flu on the similar time, too.
The Meals and Drug Administration has licensed the primary over-the-counter at-home take a look at that may detect and differentiate between a take a look at end result for flu and a take a look at end result for COVID-19.
The Lucira COVID-19 and Flu Dwelling Check is a single-use take a look at, which will be bought with no prescription. A nasal swab is used as with an at-home COVID take a look at; in half-hour or much less, the take a look at shows the outcomes – constructive or destructive for influenza A, Influenza B and COVID-19.
“At the moment’s authorization of the primary OTC take a look at that may detect Influenza A and B, together with SARS-CoV-2, is a significant milestone in bringing higher client entry to diagnostic checks that may be carried out fully at residence,” stated Dr. Jeff Shuren, director of the FDA’s Middle for Gadgets and Radiological Well being, within the announcement Friday.
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How a lot will an at-home COVID-19 and flu take a look at price?
Lucira Well being started making its COVID-19 & Flu take a look at obtainable in Canada in August 2022 and it is at the moment priced at about $70.
Insurance coverage protection can also have an effect on how a lot shoppers pay.
Lucira Well being will announce a U.S. price ticket and launch date at a later date, firm president and CEO Erik Engelson advised USA TODAY. “This can be a main milestone for Lucira Well being and at-home diagnostics, and I can’t thank our staff and companions sufficient for seeing this by, and naturally, for the FDA’s recognition,” he stated.
The corporate at the moment additionally sells an Lucira Examine It COVID-19 Check ($34.99), which is a molecular take a look at – much like polymerase chain response (PCR) lab checks – and regarded extra correct than different at-home speedy antigen checks.
Along with Canada, at-home checks for COVID and flu are already obtainable in Australia and Europe (the take a look at obtainable there additionally checks for RSV), in response to medical web site WebMD.
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How correct is the at-home COVID and flu take a look at?
The FDA stated the take a look at accurately recognized:
- 100% of destructive and 88.3% of constructive COVID-19 samples
- 99.3% of destructive and 90.1% of constructive Influenza A samples.
- 99.9% of destructive Influenza B samples.
What’s Lucira Well being?
A medical expertise firm primarily based in Emeryville, California, Lucira Well being had hoped to obtain an emergency use provision from the FDA at about the identical time it obtained authorization from Canada.
It had already begun manufacturing checks to fulfill anticipated demand – as demand for its COVID-19 take a look at declined. With out the anticipated income from the combo take a look at, the corporate has filed for Chapter 11 chapter safety and plans to pursue a sale of the enterprise, it introduced Feb. 22.
“Sadly, as restrictions lessened in 2022, we noticed decrease demand for COVID-19 checks. This, mixed with slower than anticipated regulatory approval for the brand new mixed take a look at package developed for the 2022-2023 flu season led to inadequate income and capitalization to offset expenditures,” Engelson stated within the chapter announcement. “Regardless of each effort to cut back capital outlays and restructure our enterprise, we took this motion to guard and maximize the worth of our property.”
In January, the corporate introduced the addition of a free Medi-Name telehealth name with the acquisition of its COVID-19 and Flu take a look at in Canada.
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Comply with Mike Snider on Twitter: @mikesnider.
