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New COVID-19 Test That “Will Deliver Results In About 45 Minutes” Approved by the FDA




The first rapid coronavirus test has been approved by the FDA.

For most COVID-19 tests, it takes anywhere from 24 hours to a few days to receive results.

Now, results can be determined and sent to people in as little as 45 minutes thanks to a new test that has been approved by the FDA.

The rapid test was developed by California-based Cepheid, one of the many companies that are joining the historic private-public partnership headed by President Trump.

Trump has unleased the power of the private sector and has cut red tape within federal government to make sure the fight against COVID-19 is as strong as possible.

In order to fight the virus, we need to be able to test people across the country.

Thanks to this new test, people will no longer have to wait for days to get results. People can know whether or not they have the novel coronavirus in just 45 minutes.

More details below:

This is the first test that can be performed for point-of-care patients. Results are received within the hour.

Cepheid has announced that the test kits will be shipping on Friday, March 28. They first testing kits should be arriving at their destinations and ready for use the following Monday, March 30.

CNBC has more details on the new test approved by the FDA:

This is the first coronavirus test that can be conducted entirely at the point-of-care for patients and deliver results in less than an hour. Typically, tests are sent to central reference labs that can take several days to deliver results.

Cepheid said tests will begin to ship on Friday, March 27 with plans to roll it out by Monday, March 30.

“We are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” HHS Secretary Alex Azar said in statement Saturday.

FDA Commissioner Stephen Hahn added that “today marks an important step in expanding the availability of testing and, importantly, rapid results.”

“Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory,” Hahn said.

The test, called SAR-CoV-2 Xpert Xpress, was developed by Cepheid, a Sunnyvale, California, company was designed to detect SARS-CoV-2, the virus that is causing COVID-19.

Cepheid uses a testing machine called GeneXpert that can run a full test in 45 minutes. There are currently more than 23,000 automated GeneXpert systems worldwide, with nearly 5,000 of them in the U.S., Cepheid said in a statement.

As testing capacity increases, we will have a better understanding of the actual number of cases already in the United States.

It will also help those infected with COVID-19 know to quarantine themselves from family and friends.

Fast testing will make an incredible difference in the fight against the novel coronavirus.

This is the first COVID-19 test from the private sector that the FDA has approved. 

Accuracy is of the utmost importance, especially now that the coronavirus has been classified as a pandemic.

The FDA approved the test, which is multiples faster than the current testing kits being used across the country and the globe.

CNN has more on the importance of identifying new COVID-19 infections quickly:

If cases of the disease are not identified quickly and community spread continues unchecked, it could soon overwhelm the nation's medical system, just as it did in Wuhan, China, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Vice President Mike Pence announced during a Saturday news briefing on coronavirus response that more than 195,000 Americans have been tested for the virus as cases surpassed 22,000, with about half confirmed in New York. He noted that the number does not include county hospitals or health care labs around the country. Currently, only 19,343 tests have come back positive, Pence said.

As officials work to increase the availability of the tests, they've also sought to make clear in what cases people should seek them.

Officials have urged Americans to use discretion before seeking a coronavirus test, advising them to be administered to people who are symptomatic and not for those who do not show signs that they could be infected with the disease.

"We want to remind Americans as Dr. Fauci will emphasize in a moment, if you don't have symptoms, don't do a test," the vice president said Saturday." It is another way that the American people can make sure that we are preserving the resources that our health care workers need to administer and support those who are dealing with the coronavirus and other illnesses."

Thanks to Trump's visionary leadership, private sector companies such as Cepheid will begin to expidite testing.

The scope of American ingenuity is only beginning to be revealed. 

The world is about to see the strength of the American private sector and its ability to create new, groundbreaking solutions.


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