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Dubai, United Arab Emirates (CNN) – The US Food and Drug Administration has issued an emergency permit for the first self-test for “Covid-19”, which can provide quick results at home.
The “Lucira COVID-19 All-In-One Test Kit” is a single-use molecular test available by prescription for coronavirus self-diagnosis, according to the US Food and Drug Administration on Tuesday.
The US Food and Drug Administration said the rapid test uses molecular amplification to detect the virus in people who are infected or suspected of having “Covid-19”.
The test can provide results within 30 minutes.
“Although diagnostic tests, collected from home for COVID-19, have previously been approved, this is the first fully self-administered test capable of providing results at home,” FDA Commissioner Dr. Stephen Hahn said in a statement. .
The new test uses self-collected nasal swab samples and is allowed for people 14 years of age or older suspected of having the virus.
People under the age of 13 can also use it, provided it is used by a healthcare professional.
The administration has indicated that it can also be used in places where health care is provided, such as doctor’s offices, hospitals, emergency care centers, emergency rooms and all ages, but must be collected by a healthcare professional.
“This new testing option is a major diagnostic advance in the pandemic response,” Han added.
However, some health experts have urged caution.
“The data is still emerging,” said Tom Polley, director of the Global Health Program and senior fellow for global health, economics and development at the Council on Foreign Relations, adding, “It is clear that with some prior permits for emergency use, it’s helpful to be careful what the FDA provides. But it’s definitely a promising sign. “
This home test could be another step in bringing the United States closer to the new normal.
Pulecki pointed out that if we had the ability to at least determine the viral load we have, and perhaps on a daily basis, that would help keep us safe and make others safer.
The new self-test includes a sterile swab, sample vial, test unit, batteries, and plastic bag.
The sample collected from the nasal swab is placed into the vial, which is subsequently inserted into the test unit, where it is analyzed.
Results are displayed via the test unit by changing the colors of the LED indicators, according to the Food and Drug Administration.
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