The US Food and Drug Administration yesterday authorized the first-ever at-home COVID-19 test without any prescription, which will soon be available for purchase at local stores.
In a statement released from the official website of the FDA, the over-the-counter COVID-19 test minus the prescription will allow people to determine if they have contracted the virus.
According to Ellume, the Australian company developing the product, the test will cost around $30 and will be available for purchase by January.
Earlier on, the FDA already authorized other tests devised to help people have themselves tested at home to avoid long and possibly-dangerous lines of ill patients.
However, these tests mandated consumers to send a sample to a laboratory and wait for the results. A different currently-approved test avoids bypasses the laboratory but necessitates a legitimate prescription.
Un-Boxed Rapid COVID-19 Testing kit at King Charles Court nursing home was overseeing a rapid COVID-19 test in November in Falmouth, England. The home is one of 20 across Cornwall, Hampshire and Devon that are participating in a pilot program to screen residents' family members and friends for COVID-19, to allow more ‘meaningful visits.’
5-Minute Test, Result in 15 Minutes
The at-home test enables people to buy a viable test for COVID-19 without taking the risk of a trip to a doctor to get a prescription, putting considerably more control in the potential patients' hands.
Interesting Engineering reported, the test takes approximately "five minutes to collect relevant samples, and produces a diagnosis within just 15 minutes.
In the said statement of the agency, FDA Commissioner Stephen Hahn said, yesterday's authorization is a major milestone in COVID-19 diagnostic testing.
The test kit comes with a special swab that enables a user to collect a sample from inside his nose. Since adults and children aged not younger than two years old can use the diagnostic test, the swab also comes with an extra adapter so that users can shorten the length of the device when swabbing young potential patients.
How the At-Home COVID-19 Test is Executed
For the test's execution, unlike the usual home pregnancy test, a user adds a few drops of liquid to the sample and place it inside a small plastic bag.
Results are then electronically sent to an individual's smartphone app for around 15 minutes. In an early interview with NPR, Ellume's CEO Sean Parsons said, "This is the first test which is really designed to be true at-home test yourself" and get results.
The company official said it could be used for people to have themselves tested, for instance, before they go to an event, be it a sporting, a concert, or a church activity, to lower the chance of possibly spreading the virus to others.
Ellume to Produce Roughly 100,000 Tests a Day by January
A USA TODAY report said, Ellume received approximately $30 million from the National Institutes of Health "to scale its production capacity." Parson also said the company would reach a production rate of approximately 100,000 tests a day by January.
By March next year, production should rise to approximately 250,000 each day, and by June, it should reach as high as one million units per day.
The said report also said, testing experts applaud FDA's authorization. However, some have cautioned "the cost and limited capacity will blunt" the possible impact this new test might have on the reduction of the spread of COVID-19.
Game-Changer But not Designed to Truly Stop the Pandemic
According to Harvard TG Chan School of Public Health infectious disease specialist Michael Mina, this new test "will be a game-changer, I think," in terms of helping people identify fast if their symptoms are brought by COVID-19.
However, he added, from the perspective of really stopping or massively slowing the pandemic, this Ellume-developed testing is not designed for that.
On the heels of this authorization of the Pfizer vaccine of the FDA, and seemingly, a few days prior to the succeeding authorization of Moderna equivalent, the agency has come out with another surprise for a worldwide population devastated from the impacts of this pandemic.
ALSO READ: Emergency Use of Pfizer COVID-19 Vaccine Recommended by FDA Advisory Committee
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