BodySphere Inc. said the U.S. Food and Drug Administration has issued Emergency Use Authorization for its Two-Minute Testing Kit COVID-19 IgG/IgM Rapid Test Cassette, to diagnose the novel coronavirus.
The company is working with State and Federal governments to deliver tests across the country directly to the front lines, as the United States is facing a surge in the coronavirus cases.
The test, which is designed strictly for use by medical professionals, can be administered as easy as a glucose test. Results are delivered on site in as fast as two minutes.
BodySphere said it is positioned to have millions of test kits on the front lines in weeks. The company is distributing the new testing kit, and has already contracted cargo planes to deliver the product to the front lines faster.
The test kit uses antibodies in blood to test for current or past infection. According to the firm, the tests have a 91% clinical specificity rate and a 99% clinical sensitivity rate.
BodySphere said the test kits have been used successfully in several states.
As the COVID-19 continues to sweep across the world, all the countries are racing to develop reliable diagnostic tests as well as a vaccine or treatment against the virus.
This week, the FDA has also granted Emergency Use Authorization for Abbott’s diagnostic test for coronavirus, which delivers fast positive results in as little as five minutes and negative results in 13 minutes.
Last week, Happiness Biotech Group Ltd. announced that the company, together with Fuzhou University, achieved a breakthrough in developing Covid-19 Testing Kits.
Recently, the FDA has allowed anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile as possible treatments for COVID-19 patients.
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