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FDA Approves First COVID-19, Self-Testing Kit for Rapid Results

School districts and student transporters could potentially have a new tool at their disposal when trying to not only ensure parents are not sending sick children to the school bus stop but that their own employees aren’t infected with COVID-19 and yet still reporting to work.

The U.S. Food and Drug Administration (FDA) granted on Tuesday an emergency use authorization for the first rapid-response diagnostic test that can be administered at home for people ages 14 and older who are suspected of having COVID-19. The Lucira COVID-19 All-In-One Test Kit is a single-use test designed specifically to detect the SARS-CoV-2 virus in 30 minutes or less.

The FDA also approved the kit for use in doctor’s offices, urgent care centers and emergency rooms.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Dr. Stephen M. Hahn. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

After a nasal swab is collected from an individual, the specimen is swirled in a vial that is then placed in the test unit, the FDA explained in a press release on Tuesday. A light-up display indicates in about a half-hour whether the person has tested positive or negative for the new novel coronavirus.


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The FDA advised that all people who test positive should self-isolate for 14 days and contact their health care provider. FDA added that a negative test does not mean the person who has COVID-19-like symptoms is in the clear of contracting the virus. These people should still follow up with their health care provider.

Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said the federal government will continue to work with test developers to increase the availability of at-home testing options.

Meanwhile, diagnostic company SummerBio LLC announced on Wednesday that it has partnered with the University of California at Los Angeles and the Los Angeles Unified School District to provide comprehensive SARS-CoV-2 testing that costs less than $20 per test. The company said in a statement that it plans to increase the testing capacity of its COVID-19 testing lab to reach approximately 100,000 nasal swab tests a day, with results in about 24 hours.

As has been widely reported this week, pharmaceutical company Pfizer said testing of its trial COVID-19 vaccine has shown a 95-percent efficacy rate in preventing infections. The company is seeking FDA approval “within days.”

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