When Abbott Laboratories announced a made-in-Maine coronavirus test kit last week that could produce results in minutes rather than days, excitement rippled across a nation strapped by too many patients, too few testing supplies and slow results.
President Donald Trump highlighted the Abbott product during a news conference on Monday. In other countries, including South Korea, there is evidence that early detection can save lives and slow the spread of the virus.
On Tuesday, top health officials and the White House said the coronavirus could kill between 100,000 and 240,000 Americans. The toll Wednesday was at 4,361 deaths and 199,000 positive cases, almost double the number last week, according to Johns Hopkins University. New data suggest as many as 25 percent of infected people may not show symptoms, Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, told NPR.
The new test can get quick results to frontline workers with results in minutes because it can be used at a patient’s bedside. Traditional tests require samples to be sent to outside laboratories, sometimes delaying results for a few days or more than a week in some cases.
But it has limitations. The machine that processes the test can only handle one test at a time, or four per hour. Traditional machines can handle 300 or more tests in a three hour period. The new machine needs a professional to run it, taking a nurse or doctor away from his or her duties with patients, though it can more quickly identify patients who need help and let medical personnel isolate and treat them.
“Faster is better,” said Peter Pitts, a former U.S. Food and Drug Administration commissioner and president of the nonprofit Center for Medicine in the Public Interest in New York City. “But there is no panacea. We need to use all the tools we have at our disposal. Anything additive will help with the backlog.”
Some 1 million Americans as of Monday had been tested for COVID-19, the illness caused by the coronavirus, but thousands of tests are still pending, according to the COVID Tracking Project. Maine had 600 from people considered to be of the lowest risk to the coronavirus waiting to be processed as of Tuesday.
The new test kits being made in Scarborough by Illinois-based Abbott promise results within 5 minutes for a positive test and 13 minutes for a negative test, the fastest results on the market now. The company received “emergency use authorization” for the experimental test from the FDA. Almost two dozen tests have been granted that special authorization.
Maine will soon get 15 Abbott test machines and enough supplies to test 2,400 people, Maine Center for Disease Control and Prevention Director Nirav Shah said Wednesday. There are an estimated 18,000 Abbott machines installed nationwide, but Shah said he didn’t know how many there are in Maine nor where they are.
Other treatment facilities must already own or buy the machine that processes the tests, which costs an estimated $5,000. Abbott was not immediately available to confirm that cost.
The Abbott machine uses an “isothermal” technique to examine the genetic material in the coronavirus, meaning it examines each sample at the same temperature. Traditional machines change temperatures for more specific results.
If there is a lot of the viral genetic material, the sample will read positive after 5 minutes. If there is no reading after 5 minutes, the machine continues to process the sample until 13 minutes. At that time if no genetic material registers, the sample is negative.
“The Abbott machine will probably not detect a low viral load in a patient. It is for people with symptoms and it is sensitive enough to detect the coronavirus,” said Catherine Klapperich, director of the Laboratory for Diagnostics and Global Healthcare Technologies and a professor in Boston University’s biomedical engineering department.
For the influx of patients with symptoms of the highly infectious coronavirus, the quick result can be a lifesaver, getting them care more quickly and letting health care workers know they must wear protective gear around the patient.
But the limitations on the number of tests that one Abbott machine can run per hour, combined with it diverting a nurse or doctor from their treatment work to running the machine, means the traditional machines will remain the mainstream test, Klapperich said.
The 50,000 test kits per day Abbott plans to make are also a small number compared with how many patients will need to be tested, she said.
Maine had performed at least 6.5 coronavirus tests for every 1,000 people in the state, putting Maine in the top 10 in tests completed per capita among states, according to the COVID Tracking Project. Nationally, only 3.2 people out of every 1,000 have been tested for the virus.
“But the Abbott machine could be a game changer at a large hospital if they have enough of them, say 5 or 10,” Klapperich said.
Klapperich said a positive for the Abbott machine is that the test kit contains all materials and chemicals needed to process the patient sample. Traditional machines usually require separate chemicals, swabs and other equipment. Recently, one chemical was in short supply and held up testing.
She said that while Abbott could experience supply shortages of some of its materials, it has a broad product network, including swabs and its own traditional test.
The current COVID-19 tests, which include other rapid tests that take longer than Abbott’s and a lot of traditional tests, cannot test for antibodies, which the body makes after it is infected. Antibodies typically may provide immunity, but scientists have not said conclusively whether that will be the case with the novel coronavirus.
Henry Schein, a New York-based health company, released an antibody test last week that it says can help assess the likelihood of past and present infection and help determine if someone has recovered from the virus.
Klapperich said that broad antibody testing in COVID-19 patients will come, but right now the focus is on testing whether people have the disease.
“This is an all-hands-on-deck situation,” she said.
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