FDA Approves New Rapid COVID-19 Test

FDA Approves new rapid COVID-19 test

As the COVID-19 continues to spread through our nation, experts and lead officials have started to search for better ways to test for and treat the virus. The Food and Drug Administration recently approved a rapid COVID-19 test that will now provide results in as little as 45 minutes, as compared to the previous test result time of 72 to 96 hours.

One of the biggest issues with coronavirus is the incubation period in which people don’t even realize they have it, even when symptoms first begin. The shortness of breath, the tell-tale sign that your “cold” might actually be coronavirus, does not appear in most patients until a few days after the fever and runny nose (which could also blamed for a cold or a plethora of other seasonal viruses). With COVID-19 being a highly contagious virus, early detection would help to mitigate exposure as people would be able to find out they have it sooner rather than later. Don’t believe us? Just check out South Korea.

Related: 8 Things You Need To Do RIGHT NOW To Fight COVID-19

The new rapid coronavirus test was approved by the FDA by Emergency Use Authorization. The test was developed by Cepheid, a molecular diagnostic company in California. The FDA approved the EUA earlier this month, and in a statement made by Cepheid, they stated that they plan start shipping the test this week with a full roll-out available to hospitals and clinics by March 30th.

However, this new rapid coronavirus test may not be available where you are. Cepheid makes note that their test will be available for on-location testing in places that have their GeneXpert Systems already in their labs. Cepheid President Warren Kocmond said in the Cepheid statement that Cepheid currently has nearly 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals. Worldwide, they have more than 23,000 automated GeneXpert systems. Otherwise, test samples will still have to be sent out to other locations for testing which again, can take days for results. You may not be able to walk into your local urgent care facility to get the test either. The test will first ship to hospitals and emergency rooms.

However, the EUA by the FDA is a big step towards mitigating the spread of coronavirus. EUA is only authorized by the FDA in the most stringent of circumstances, and this global pandemic is one of them. The U.S. Department of Health and Human Services Secretary Alex Azar stated that “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort…More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”

The rapid coronavirus test is also a bit more comfortable for patients. Instead of the deep nasal and throat swabs necessary for the traditional coronavirus test, this new fast-results test is done by spraying a salt-water type solution into the patient’s nose and collecting the residue that emerges. However, if your rapid test is negative, your doctor still might have you complete the traditional test if he or she believes you have coronavirus.

Related: COVID-19 Helped Me Get Out of My Work FOMO

It is unclear whether this rapid coronavirus test will fall under the previous government-mandated waived fees for coronavirus testing, or how much the test might cost for individuals out of pocket. There is also no statement from Cepheid, the FDA, or the Department of Health and Human Services about the accuracy of the rapid coronavirus test at this time. Dr. David Persing, chief medical and technology officer at Cepheid, did note that the test is “accurate” but not to what degree. He states that “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.”

It is important to note that despite this new rapid coronavirus test becoming available, it’s still recommended you should not get tested unless you have symptoms. (Or you’re rich, but that’s an ENTIRELY different story.) Resources for testing and for labs are still scarce, and those resources need to be available for those with symptoms showing. However, hopefully, as the months continue we will all be able to be tested so we can better mitigate the spread of coronavirus before we show symptoms if we even show them at all.


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