May 07, 2020
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FDA approves first in-home test for COVID-19. Maine proceeds cautiously.

Robert F. Bukaty | AP
Robert F. Bukaty | AP
Downtown Gardiner, Maine, is nearly deserted, Monday, April 20, 2020. The state is under a stay-at-home order to help prevent the spread of the coronavirus.

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The U.S. Food and Drug Administration approved the first in-home test for COVID-19 on Tuesday, permitting one company to sell kits that allow people to collect nasal swab specimens on their own.

The FDA worked with the company, LabCorp, to ensure that taking samples at home “is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” it said.

[Our COVID-19 tracker contains the most recent information on Maine cases by county]

Despite limited capacity to test for COVID-19 in Maine, the state is proceeding carefully and reviewing how well the home collection kits work before promoting their use, Nirav Shah, the director of the Maine Center for Disease Control and Prevention, said Tuesday afternoon.

The FDA authorized its approval on an emergency basis.

“Things are getting approved without necessarily having the full battery of tests, which means that our laboratory staff, our statisticians, have to be extra careful to review those data right now, to make sure we know what we’re actually acquiring,” Shah said.

Once patients complete a nasal swab, they mail their sample in an insulated package to a LabCorp lab for testing, LabCorp said. It is currently prioritizing distribution of its kits to health care workers and first responders who are symptomatic or were exposed to COVID-19.

But it said it intends to make the kits available to consumers who have a doctor’s order “in the coming weeks.”

Called Pixel by LabCorp, the kits cost $119, and customers have to pay upfront.

Pixel by LabCorp does not bill insurance for this testing, a company spokesman said. Rather, patients should contact their insurer to determine if their plan would reimburse them.

Results are usually available within one to two days after the sample has been received by the lab, though this can vary based on demand, the spokesman said.

Health care organizations across Maine said they would be researching the test and trying to understand more about it.

Maine Medical Center clinicians “are just learning about this testing option and are evaluating what role, if any, home collection of samples might play in treating patients suspected of having COVID-19,” said a spokesperson for the Portland hospital.

“We do feel it is important to note that we currently are using the most accurate test available now with an appropriate turnaround time for results,” said Suzanne Spruce, a spokesperson for Northern Light Health.

The kit may be helpful if people can follow its directions and obtain the sample properly, said Dr. Noah Nesin with Penobscot Community Health Care.

“These tests are most useful when there is a seemingly low likelihood of infection but knowing a test result could make a significant difference in decision making,” he said.

Medical providers might order the in-home test if it proves accurate and is covered by insurance — but only if their own testing supply remains limited, added Dr. David Koffman, with St. Joseph Healthcare.

“In the Bangor area, we have not been having any trouble testing health care providers, and the test currently is limited to them, so I don’t feel this is something that will change things right now,” Koffman said. “When this becomes more widely available, I could see the benefit if the test is indeed accurate.”

Watch: State sets up hotline for health care workers

 


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