The FDA approves a new test that detects coronavirus in 45 minutes

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The Food and Drug Administration (FDA) has approved a coronavirus test that can provide a diagnosis of COVID-19 in as little as 45 minutes. The test, performed by Cepheid, a California-based molecular diagnostics company, got emergency clearance on Saturday 21 March, eight days after the agency quickly authorized a test from Roche, which can diagnose the new coronavirus in three hours.

The response time in test results so far ranges from 24 hours to four days, which is causing a number of problems in its own realm. The tests will begin shipping this week, according to a statement from Cepheid, which manufactures the new tests.

"During this time of increased demand for hospital services, doctors urgently need a real-time diagnostic test for the treatment of patients being evaluated for admission to health facilities," said David Persing, Cepheid's medical and technology director.

The company has not communicated how much the tests will cost.

"Accurate testing close to the patient can make a difference and help relieve the pressure that the emergence of the COVID-19 outbreak has placed on health-care facilities that need to properly allocate their respiratory isolation resources," Persing added.

The diagnostic test has been designed to work in any of Cepheid's 23,000 automated GeneXpert Systems worldwide.

This announcement of much more efficient coronavirus testing comes as the medical community seeks precisely to obtain faster results to stem the wave of infections of recent days in many countries around the world, such as the United States, Italy and Spain.

However, it is likely that at this time the tests will only be used in a hospital setting, where the patient is already in an emergency room or hospital triage wing and needs a quick diagnosis, not for people concerned about their condition who go to the doctor's office.

In part, this is because Cepheid's production capacity is limited; it can produce millions of tests in the coming weeks, but not every week.

The United States and Spain are two examples that have been affected by a severe testing shortage, allowing the new SARS-CoV-2 coronavirus to spread undetected for weeks. In addition, in the U.S., the test kits initially sent out by the Centers for Disease Control and Prevention were defective, and for weeks the government prohibited local laboratories from developing their own kits, causing the country to see an unstoppable increase in cases of infection in recent weeks (the global shortage of essential chemicals needed to perform the tests did not help either).

Meanwhile, the World Health Organization has called for "order and discipline" in the marketplace for the health kits needed to combat the outbreak.

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