FDA approves new coronavirus test that delivers results in 45 minutes

One of the biggest roadblocks to getting ahead of the spread of coronavirus is the lack of efficient, accessible test kits.

In what has been described as a “key milestone” in the fight against COVID-19, Cepheid, a medical device manufacturer, announced on Saturday that the FDA had approved their COVID-19 test, which delivers results within 45 minutes. 

Testing lag

Over a week after Donald Trump declared the coronavirus outbreak in the US to be a national emergency, it’s still difficult to get tested for a suspected case of COVID-19. Additionally, most tests can take 48 hours or more to deliver results.

Until March 11, only 11,000 tests had been administered in the U.S. After Trump’s emergency declaration, commercial labs stepped in and boosted the numbers to 142,000 tests as of Saturday. While the number of tests administered has risen dramatically, it’s still not enough.

South Korea’s successful management of its coronavirus outbreak is largely credited to an aggressive testing protocol. According to Lee Sang-won, an infectious disease expert at the Korea Centers for Disease Control and Prevention, South Korean officials “acted like an army” in the very early days of the nation’s coronavirus outbreak.

In early February, just one week after the first cases were reported in the country, the South Korean government had approved a test for the virus, with more on the way. Residents were able to access tests via drive-through and got their results quickly, allowing officials to quarantine the sick during the most contagious stage of their illness.

According to Reuters, at this point, South Korea has tested more than 290,000 individuals and reported 8,000 infections with a death toll at just over 100. The nation appears to be on the downslope now, recording only 93 new cases on Wednesday, a significant reduction since their peak of 909 per day two weeks ago.

Major breakthrough

U.S. infectious disease experts are hopeful that breakthroughs in rapid, accessible testing will help the U.S. follow South Korea’s trajectory. However, testing efforts in the U.S. have fallen so far behind, it will take a monumental effort to test enough individuals to contain the virus at this point.

It’s not all doom and gloom though. Former FDA commissioner Dr. Scott Gottleib tweeted after the announcement that “Approval of Cepheid system for rapid point of care #COVID19 testing is key milestone. We need other point of care tests like swabs that give readable results. Testing and serology are key to complementing population based mitigation with case containment.”

The FDA was not expected to approve a rapid COVID-19 test until April, but Emergency Use Authorization allowed the company to bypass much of the red tape typically involved in the process of approval.

FDA Commissioner Stephen Hahn, M.D said of the development:

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. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.

Cepheid’s new rapid testing kit will begin shipping out next week, and President Warren Kocmond said that the tests are compatible with 5,000 GeneXpert Systems located throughout the US, and another 18,000 around the world. 

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