CHICAGO – A five-minute, point-of-care coronavirus test could come to urgent care clinics next week, and experts say it could be “game-changing.”
The US Food and Drug Administration issued emergency use approval to Illinois-based medical device manufacturer Abbott Labs on Friday for a coronavirus test that produces positive results in as little as five minutes and negative results in 13 minutes, the company said.
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The company expects that the tests will be available next week and expects to increase production to deliver 50,000 tests per day.
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“I am pleased that the FDA approved Abbott’s care test yesterday. This is great news and will help get more of these tests out in the field quickly,” FDA Commissioner Steve Hahn said in a statement. “We know how important it is to get care points quickly out in the field. These tests that can give results quickly can be a game changer when diagnosing COVID-19.”
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Scott Gottlieb, former FDA commissioner, echoed Hahn’s comments on Twitter, the development calls it a “game changer.” Gottlieb also said that it is “very likely” that we will see additional medical diagnostics approvals behind this, and extend testing to medical offices across the United States.
The new test comes in the form of a small cartridge that fits in the hand, said John Frels, Abbott’s vice president for research and development.
The test runs on the company’s ID NOW platform, a 6.6-pound portable unit the size of a small toaster. There are currently about 18,000 ID NOW instruments in the United States – the most widely available molecular evaluation platform in the country, Frels said.
Unlike high-throughput batch test platforms that can run hundreds of tests at a time but take several hours, the ID NOW platform is an instrument used in medical offices and emergency clinics. The platform is usually used to perform tests for other respiratory diseases, such as influenza, strep and RSV – and similarly uses samples from throat and nose chips.
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Last week, the FDA approved another Abbott coronavirus test, the m2000 RealTime SARS CoV-2 EUA test, which is used for large batch testing at university and community hospitals. Between the two platforms, Abbott expects to produce about 5 million tests a month.
“We believe this pandemic will be combated on a number of levels, beginning with the diagnostic front being able to clear the backlog of tests. This is done by making high-volume flow tests available and in the front lines when patients present themselves in emergency care,” so Frels.
Abbott did not immediately say whether it planned to manufacture more ID NOW platforms, in addition to the new test cartridges. Company spokesman Darcy Ross said the company was working with the Trump administration to decide where the tests would be sent.
Other companies have also been approved for emergency use by the FDA, which allows the use of unauthorized medical devices during a public health emergency.
California-based Cepheid said last week that it was granted a test that the company says will produce results within 45 minutes. Another California-based company, Mesa Biotech, said Tuesday that it received approval for a palm size test that the company says results in 30 minutes. The test is intended for use at temporary screening facilities, medical office laboratories, urgent care and long-term care facilities.
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USA. has struggled to get us tested across the country, and in the early days of the outbreak, the Centers for Disease Control and Prevention initially developed and emailed incorrect test kits. Many doctors have reported rationing tests to prioritize the most vulnerable.
Public health labs, as well as approved private laboratories, universities and hospitals, can perform the tests. As of March 26, 92 public health laboratories in 50 states plus Washington D.C., Guam and Puerto Rico had successfully verified COVID-19 diagnostic testing and offered testing, according to the CDC.
Although there are no official nationwide test totals, the COVID Tracking Project, an online effort by two journalists to track the number of tests conducted in the United States, said Friday that more than 620,000 tests had been conducted all over the country – most tests done by any country.
But the United States, with a population of about 329 million, does not lead the world in the number of tests per capita. South Korea, a country of about 51 million, had tested more than 370,000 people as of Friday, according to health officials. Italy, which has a population of 60 million and has reported the most coronavirus-related deaths, has tested more than 390,000 people, according to health officials.
Dr. Deborah Birx, the White House corona virus response coordinator, said in a Friday briefing that about 95% of tests in the United States are done in commercial laboratories. The $ 2.2 trillion stimulus package approved on Friday will require those labs to report total test numbers, Birx said.