THE Food and Drug Administration has approved an emergency use authorization for the first rapid at-home Covid-19 test that can quickly get you the results at home.
The Lucira Health Covid-19 All-In-One Test Kit is a molecular single-use test available by prescription only and solely approved for those 14 and older for self-diagnosis of the coronavirus.
According to the FDA, the kit can return results in 30 minutes.
“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Dr Stephen Hahn said in a statement.
“Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
A molecular Covid-19 test searches for signs of the coronavirus genetic material.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” Dr Hahn added.
The test produces the results in just a few step. First, users take a nasal swab, which they then place into a vial that plugs into a portable testing unit.
Within 30 minutes, the device interprets the results and displays using LED lights whether the person tested positive or negative for Covid-19
The kit is authorized for people 14 and older with suspected coronavirus – however, a health care provider has to perform the test for those 13 and younger.
The new self-testing kit includes a sterile swab, a sample vial, a test unit, batteries and a plastic disposal bag.
The FDA has authorized nearly 300 coronavirus tests to date.
Previously, a handful allowed people to collect their own nasal or saliva sample at home and ship it to a lab, where folks typically receive their results within a few days.
Experts say allowing people to test themselves at home will help reduce turnaround times and curb the possible spread of the virus to healthcare workers.
The authorized at home self-testing kit comes after both Moderna and Pfizer announced their Covid vaccine is nearly 95 per cent effective.
On Monday, Moderna said its two-dose jab was 94.5 percent successful at fighting the deadly virus in infected volunteer – and Dr Anthony Fauci said it may be rolled out as soon as December,
While the Pfizer-BioNTech vaccine has met the safety criteria needed for emergency authorization, the firm said Wednesday.
And company bosses plan to submit the vaccine to the regulators in the US for emergency use approval “within days” before sharing with others around the word.
Pfizer chairman, Dr Albert Bourla said, “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic.
“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”
The vaccine news and self Covid-19 home test are steps that could bring the country closer to a new normality.
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