Coronavirus: How to Get First FDA Approved Rapid Test

Coronavirus testing has been a hot topic across the nation over the past two weeks. President Trump and The White House pandemic team have faced a steady stream of questions about testing since declaring a national emergency a week ago. Many have questioned why the government didn't accept tests from the World Health Organization while ramping up our the nation's production.

Adjustments have been made since then and now the FDA has approved a rapid test for the virus that can give results within 45 minutes. While this is far from the numerous take-home tests that are now being offered without FDA approval, it does offer healthcare professionals a speedier test for those who will need them in the coming days.

The test, named Xpert Xpress SARS-CoV-2 is being produced by Cepheid under approval by the FDA according to PEOPLE. The emergency use authorization allows the company to ramp up production and deliver tests immediately, with Cepheid saying tests will begin to ship next week.

"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 Pershing, 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 statement adds that there are 5,000 GeneXpert Systems from the company that are capable of point-of-care testing in hospitals. This fact is reportedly what allows the test to move so quickly, alongside automation.


"Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today," Cepheid President Warren Kocmond added in the statement.

With the rise in testing, there will be a rise in reported cases. Some states have already decided to forgo tests on those who have symptoms but could quarantine until they recover, so the news that some tests have been fast-tracked is refreshing news. It is especially comforting as death tolls rise exponentially in Italy, with over 700 being reported in one day Saturday.