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The United States has issued emergency clearance for the first rapid diagnostic test for coronavirus, which according to the Food and Drug Administration (FDA), granted with information by agencies, can be done at home.
That is a kit allows users to collect a nasal sample with a nasal swab which, upon rubbing, comes into contact with a vial containing a laboratory solution which in turn is connected to a portable device that emits colored lights that can be identified as positive
Although the FDA has so far authorized nearly 300 diagnostic tests for covid-19, most of them require professionals to collect and process the samples, as well as the interpretation of the results, including those that allow the person to take the sample, so this it would be the first sample that can be done independently.
(Read also: Oxford vaccine generates a safe and immune response in the elderly)
“Now more Americans who may have COVID-19 will be able to take immediate action, based on their findings, to protect themselves and their environment,” said Jeff Shuren, director of the FDA’s Center for Devices, in a statement. . .
For its part, the manufacturer of the test, Lucira Health, a Californian company, did not develop the product, but it emerged that it developed it from research the company had conducted for home tests for influenza.
The test uses a file technology similar to laboratory tests based on the genetic information of the virus which are the standard tool for diagnosing covid-19, in other words, it identifies the virus from its main structure.
According to the FDA, the system has also been cleared for use in medical centers, and all findings must be reported to federal state authorities to monitor the pandemic.
In this sense, the test requires a prescription and the professional who orders it is obliged to report the results. It is worth noting that the FDA does not specify the sensitivity of the test and the studies on which the authorization was based.
(Plus: Study Finds Coronavirus Immunity Could Last For Years)
For now it has emerged that The kit is worth about $ 50 and its results are achieved in 30 minutes. It goes without saying that in Colombia, in order for this test to be available, it will have to go through the studies, analyzes and approval of Invima, subject to validation by the National Institute of Health. For now its use is not authorized.
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