A Maine laboratory helped design and will mass produce a new COVID-19 test that will give results within minutes.

National public health experts are calling the made-in-Maine tests a potential “game changer” in the fight against the novel coronavirus pandemic.

Lack of early and widespread testing is considered by scientists to be one of the failures of the Trump administration. Abbott Laboratories and other private testing labs are working to fill the supply gaps left by the U.S. Centers for Disease Control and Prevention.

The tests – about 50,000 produced per day – will be made solely at Abbott’s Scarborough plant, starting this week. The Scarborough location has worked for years on rapid-fire flu tests that are used around the world. The COVID-19 tests, like the rapid flu tests, will cost about $40 each.

Norman Moore, scientific affairs director for Abbott’s Scarborough location, told the Press Herald in a phone interview that production will ramp up this week. Abbott scientists in Maine, California and Illinois moved within a few weeks from an idea to producing the new tests because the tests use similar equipment that the company employs for influenza testing, Moore said.

The Food and Drug Administration approved the tests on Friday. Dr. Scott Gottlieb, the former FDA commissioner, responded to the news enthusiastically.

“This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min,” he tweeted on Friday.

The test kits will have all the components necessary for health care workers to use as soon as they receive them, Moore said, including reagents. Reagents – which have been in short supply for labs looking to expand testing in the U.S. – are chemicals used to isolate the virus’ genetic code so that it can be tested.

“This is really an historic moment,” Moore said. “The feeling that we have been able to make these tests this quickly is quite amazing.”

Eric Feigl-Ding, an epidemiologist and health economist at the Harvard T. H. Chan School of Public Health who has been advocating for expanded testing in the U.S., echoed Gottlieb’s assessment in his own tweet Friday.

“HUGE! Abbott Laboratories is unveiling a #COVID19 test that can tell if someone is infected in as little as 5 minutes, and is so small and portable it can be used in almost any health-care setting.”

Abbott, an Illinois-based company that has a laboratory and manufacturing plant in Scarborough, will start producing the tests on Wednesday, with a capacity to do 50,000 tests per day, or more than a million per month. Called ID NOW, the test machine, which is about the size of a toaster, can produce a positive test within 5 minutes and a negative test within 13 minutes.

Moore said the test will help patients and health care systems on a number of fronts. For instance, health care workers can better conserve their protective gear, such as masks, gloves and gowns, if they know whether a hospital patient is positive or negative within minutes of receiving the test. Currently, a patient at a hospital who has COVID-19 symptoms must be considered to be positive for the disease while waiting for results to come back, which currently can take a few hours to a few days.

“The idea was to bring this test to the front lines of the fight against the virus,” Moore said.

According to the COVID-19 Testing Project, which tracks public reporting by the states of how many tests have been conducted, the U.S. has tested at least 850,000 people, with about 140,000 testing positive, as of Monday. More than 2,500 Americans have died from the disease. In contrast, South Korea began extensive testing much more quickly than the U.S. and has tested about 4,000 people per 1 million population, compared to less than five people per 1 million in the U.S., according to Harvard Business Review. South Korea’s testing strategy “flattened the curve” and the health system there has not been overrun. About 150 people have died in South Korea of the novel coronavirus, out of a population of 51 million.

The Abbott tests will be immediately shipped to hard-hit areas of the country, such as New York and Michigan, but some also could soon be used in Maine.

John Koval, an Abbott spokesman, said the tests “will be available in Maine,” but as of Monday he couldn’t provide details about how many or when.

Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said the development is promising, but it would potentially add to and not supplant the testing Maine is already doing. Maine has been having problems with testing backlogs, which reached about 1,300 last week but have been cut by nearly in half since then, to about 800.

Shah said on Monday that the current capacity is about 3,000 tests. Maine has already performed more than 6,000 tests, with 275 positive as of Monday.

“It’s a big step forward,” Shah said. “We are very interested in this test and its ability to turn around a result very quickly.”

Stanley Schofield, president of MaineHealth’s NorDx Laboratories, said the Abbott tests are a welcome development, but it’s unclear how many will be quickly made available to Maine hospitals. Schofield said he’s requested the test kits from Abbott, which would be especially useful in hospital settings.

“We could really use them if we could get them,” Schofield said. “Getting to know a patient’s COVID-19 status is really important. Minutes count.”

Schofield said with results in minutes instead of hours, hospitals can more efficiently use their resources, not only protective gear, but also decisions about whether to use negative-pressure rooms – which help prevent cross-contamination in hospitals – and how to allocate staff.

“It would really help us leverage our existing resources,” Schofield said.

Schofield said it’s too early to tell whether the Abbott tests will help alleviate national problems with testing supplies. Many labs and government agencies are working to address shortfalls.

“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” Robert Ford, president and chief operating officer of Abbott, said in a statement. “With rapid testing on ID NOW, healthcare providers can perform a molecular point-of-care testing outside of the traditional four walls of a hospital in outbreak hot spots.”

Abbott makes rapid tests not only for influenza, but also to detect other common infectious diseases, such as pneumonia, strep, a respiratory virus and HIV.

After the news of the rapid test became public, shares of Abbott stock rose more than 6 percent in day trading on the New York Stock Exchange on Monday, to $79.34. The stock’s price has ranged from $61.61 to $92.45 during the past year.

 

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