The US manufacturer Lucira Health’s test received an authorization for emergency use, the FDA said in a statement, where it stressed that it is for single use and is “intended to detect the new SARS-CoV coronavirus. -2 causing covid-19 “. . / TANNEN MAURY / Archive
Washington, Nov 18 . .- The US Food and Drug Administration (FDA), in charge of giving the green light to the commercialization of drugs, authorized this Wednesday the first test of covid-19 to self-diagnosis at home, the result of which can be known in a maximum of 30 minutes.
The test from the US manufacturer Lucira Health received an authorization for emergency use, the FDA said in a statement, where it stressed that it is single use and is “intended to detect the new coronavirus SARS-CoV-2 that causes covid-19 “.
The test, which can be accessed with a prescription, can be used at home for people over 14 years of age suspected of having contracted the disease; or in healthcare facilities, such as doctor’s offices, hospitals, first aid clinics, and emergency rooms.
“While there are covid-19 diagnostic tests that have been authorized for collection of samples at home, this is the first test that can be completely done and provide results at home,” said the FDA commissioner, Stephen Hahn, in the statement.
For the official, this new option “is an important diagnostic advance to address the pandemic and reduce the public burden of disease transmission.”
The test is applied by collecting a nasal sample through a swab, which is then placed and removed in a vial to impregnate it.
This tube is then placed in a test unit, which in 30 minutes or less will provide the result, positive or negative, on a bright screen.
The FDA clarified that those who test positive will have to isolate themselves and seek health care; and if it is negative, but the person has symptoms similar to those of covid-19, then you should consult with your doctor, since such a result does not rule out that the person may have contracted the virus.
The test will also allow the tracking of cases, since the doctors who prescribe the test must report all the results they receive.
The new test was approved at a time when the US is experiencing a rebound in the pandemic, which is the most affected country in the world.
According to the independent count of Johns Hopkins University, the US exceeded a quarter of a million (250,029) deaths from covid-19 this Wednesday, while infections close to 11.5 million.