Europe Approves 15-Minute COVID-19 Test - COVID-19 Clinical Trial
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Europe Approves 15-Minute COVID-19 Test

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    While the rapid BinaxNOW coronavirus test is making waves in the United States, another company is accomplishing the same feat in Europe. 

    Becton, Dickinson and Co.’s COVID-19 test has officially been cleared for use in countries that accept Europe’s CE marking, even though it’s still only accepted under an Emergency Authorized Use agreement by the FDA in the United States.  

    The test is expected to become available at the end of October for use in emergency departments, pediatricians, and doctor’s offices.  

    How Does the BD Rapid Test Work? 

    Becton, Dickinson and Company, more commonly known as BD, is a leading global medical technology company based in New Jersey.  

    According to an announcement published by BD over the summer, its “simple new assay leverages more than 25,000 BD Veritor™ instruments already used across the U.S to immediately increase access to COVID-19 testing in frontline health care settings.”  

    The BD Veritor™ system was developed for rapid detection of SARS-CoV-2 assay. Research indicates the test achieves 84% sensitivity and 100% specificity, which matches the benchmark of other common tests for the flu, RSV, and Strep A.   

    “This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD.  

    It’s only slightly larger than a cell phone and works with one button to offer real-time testing and reporting. Results are available within 15 minutes.  

    “The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of Covid-19,” BD EMEA Roland Goette said. 

    BD’s Rapid Test Approved for use in Europe 

    The FDA has yet to approve BD’s rapid test for anything more than an EUA, but it’s considered a “game-changing” device in Europe.  

    According to BD, the company is harnessing its global manufacturing footprint to ramp up production as fast as possible. BD expects to have 8 million COVID-19 antigen tests per month by October and 12 million tests per month by March 2021.  

    However, BD isn’t without some friendly competition in Europe. Another test developer, LumiraDx, also received the CE marking for its antigen test this fall. The company plants to produce 2 million tests in September, and as many as 10 million in December.  

    For people around the world working to protect themselves and their loved ones from the coronavirus, the accessibility of rapid testing may be the key to safety and health.  

    SOURCES: 

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