Rapid Coronavirus Test Approved by FDA, Results in 45 Minutes

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The Food and Drug Administration approved a rapid coronavirus test on Saturday that will deliver results in about 45 minutes. The test will be available in the next few weeks and no training will be necessary to administer the tests.

Cepheid, a California-based diagnostic testing company, announced on Saturday that the FDA approved the use of its XpertXpress Sars-CoV-2 rapid molecular diagnostic test for the detection of the Chinese coronavirus that causes COVID-19. The test is designed to work on any of the company’s more than 23,000 automated worldwide testing systems. The test provides results in about 45 minutes, company officials said in a written statement.

“During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid said in the statement. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

The company states it currently has nearly 5,000 of its GeneXpert Systems located across the U.S. that are capable of point-of-care testing. – READ MORE

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