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The US authorizes a rapid test for COVID-19 to be done at home

Regulatory authorities in the United States have authorized the emergency use of the first rapid coronavirus test that can be done entirely at home and offers results in 30 minutes.

The announcement by the US Food and Drug Administration (FDA) was a major step in the US efforts to expand COVID-19 diagnostic testing options beyond health centers and points. of tests. However, the test will require a prescription, which will likely limit its initial use.

The FDA granted emergency authorization for the single-use kit from Lucira Health, a California manufacturer.

The company’s test allows users to take a nasal swab themselves. The nasal swab is then rubbed into a vial with a laboratory solution that is connected to a portable device. Results are displayed as colored lights identified as positive or negative.

So far, the FDA has authorized nearly 300 diagnostic tests for coronavirus. The vast majority require a healthcare professional to take the samples from the nose and they must be processed in laboratories using high-tech equipment. Some allow people to collect samples at home – either with a nasal swab or a saliva sample – which is then sent to a laboratory, and often requires a wait of several days for results.

Health experts have called for options that allow people to get tested at home, reducing waiting times and the possible spread of the virus to others, such as healthcare workers.

Rapid tests are crucial to quickly quarantine those infected and trace their contacts. But for months, diagnoses in the United States have been marked by slow results due to the capacity of laboratories.

There are other quick tests, but most require a special little machine operated by a professional to get the results.

“Now, more Americans who may have COVID-19 will be able to immediately take action, based on their results, to protect themselves and their environment,” Dr. Jeff Shuren, director of the FDA’s device center, said in a statement.

Lucira did not initially respond to a request for additional details, sent after the end of her working hours on Tuesday.

Lucira’s system was developed from the company’s research for a home flu test, according to the company’s website. Lucira adapted her technology to detect COVID-19 after the outbreak.

The test uses a technology similar to laboratory tests based on genetic information that are the standard tool for detecting the new coronavirus. Instead, most of the rapid tests now in use in the United States look for viral proteins called antigens, not the virus itself.

Anyone who tests positive should isolate themselves and seek medical attention, the FDA said in its press release. People who test negative but still have symptoms of coronavirus should see a doctor, as a negative result does not rule out a COVID-19 infection.

The system was also licensed for medical consultations and testing centers. All test points in the United States must report their results to state and federal authorities to keep track of the pandemic. Physicians will be required to report test results at home.

The FDA authorized the new diagnostic test using its emergency powers to accelerate the availability of experimental products during public health crises. Under normal circumstances, the agency requires tests of safety and effectiveness before giving the green light for a new test. But those demands can be lowered during public health emergencies.

The FDA did not release the reliability of the test or the results of the study used by regulators to make the decision.