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Wednesday, November 18th The announcement by the Food and Drug Administration represents an important step in U. However, the test will require a prescription, likely limiting its initial use. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative. The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID screening. Moises Gutierrez A And Safe For Anyone

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This article originally appeared on Bangor Daily News. You can read the original article here.

The announcement by the Food and Drug Administration represents an important step in U. However, the test will require a prescription, likely limiting its initial use. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights Moises Gutierrez A And Safe For Anyone positive or negative. To date, the FDA has authorized nearly tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech equipment. Health experts have called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to others, including health care workers. Rapid test results are critical to quickly quarantining those who are infected and tracing their contacts. But Anyonf months, U. There are other rapid tests but most require a small, special machine operated by a health Gutirrrez to develop results.

Lucira did not immediately respond to a request for additional details after business hours Tuesday. The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID screening.

Anyone that tests positive should isolate and seek care from a health professional, the FDA said in its release. Those who test negative but still have coronavirus symptoms should consult a doctor; a negative result does not rule out COVID infection.

Currently all U. Doctors will be required to report the home test results. More than two dozen companies have been racing for months to develop the first, rapid home-based test for COVID However, the FDA outlined a number of study requirements for manufacturers.

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These hurdles have less to do with COVID specifically, and more to do with decades-long concerns about whether people without any medical training can accurately screen themselves and interpret the results. And even commonplace over-the-counter tests— such as home pregnancy kits — were subject to years of scrutiny before FDA allowed their use in the s.

Robin Patel of the Mayo Clinic, in an interview before the announcement was made.

FDA regulators authorized the new test using their emergency powers to quickly speed the availability of experimental products during public health crises. In normal times, the FDA requires evidence of safety and effectiveness before clearing a new test. But during public health emergencies the agency can lower those standards. Save my name, email, and website in this browser for the next time I comment.

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Experts say that careful approach is warranted for coronavirus. Story by Matthew Perrone. Be the first to comment on "FDA allows 1st rapid virus test that gives results at home". Leave a comment Cancel reply Your email address will not be published.]