COVID-19 tests made by Scarborough company coming under scrutiny - Press Herald

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A rapid-fire test manufactured in Scarborough that can detect COVID-19 within minutes is coming under scrutiny after preliminary findings from a new study indicate that it is returning a high rate of false negative results.

The study of the Abbott Laboratories test, which has not yet been peer reviewed, was conducted by epidemiologists at New York University who shared their findings with The Washington Post. The ID Now test made by Abbott, which has been touted by President Trump and is used in the White House, missed from 33 to 48 percent of positive samples found by other tests, the Post reported Thursday.

The tests are being made solely at Abbott’s Scarborough plant, which has been producing about 50,000 tests per day since early April. The Scarborough location has worked for years on rapid-fire flu tests that are used around the world. The COVID-19 tests, like the flu tests, cost about $40 each, and give results within 13 minutes.

The Chicago-based company defended the tests’ accuracy in a statement to the Post on Wednesday. Abbott spokesman John Koval told the newspaper that the company questioned how the samples were collected and that the test was “performing as expected,” according to its customers.

“The NYU study results are not consistent with other studies,” Abbott said in a statement on its website. “For example, in another recent study in Washington state, out of approximately 1,000 subjects there were 23 positive for COVID-19 on a lab test and ID NOW picked up 21, demonstrating 91 percent sensitivity and 100 percent specificity.

“While no test is perfect, Abbott’s ID NOW is delivering reliable results when and where they’re needed most.”

Kimberly LaFleur, an Abbott spokeswoman, told the Press Herald that the company plans “to increase ID NOW manufacturing capacity to 2 million tests a month by June. The majority of these tests have been sent to outbreak hotspots and we’ve asked that customers prioritize frontline health care workers and first responders.”

In Maine, the state CDC has received 345 of the tests since April through the federal government and a donation by Martin’s Point Health Care. Martin’s Point, a network of primary care offices, received about 1,000 of the tests. The Maine CDC was expecting to receive thousands of tests, but the federal government redirected them to areas of the country with more severe COVID-19 outbreaks.

Dr. Nirav Shah, director of the Maine CDC, said the agency is conducting its own analysis of the accuracy of the Abbott tests to see how they stack up against other tests at the state lab. The analysis is ongoing and he said he didn’t have any results to release on Thursday.

“We wanted to see for ourselves what the experience has been in Maine, what the accuracy is for that test,” Shah said.

He said that from what he’s heard, a positive result from the Abbott test “can be taken to the bank,” but that negative tests may not be as accurate.

“That all sounds dire, but there’s no such thing as a perfect test,” Shah said. “All tests have some degree of accuracy tradeoffs.”

Meanwhile, Maine is ramping up its testing capacity, doubling its testing within the past week, and will add another 5,000 tests per week through a partnership with Idexx. The boost in testing will expand Maine’s capability to conduct comprehensive testing and tracing of close contacts.

If successful, testing and tracing can halt the spread of the novel coronavirus. Other countries, such as South Korea, have succeeded in keeping cases and deaths down with widespread testing and tracing.

Shah said some of the Abbott tests are being redistributed to areas where there is a need for more testing capacity. He said that includes Cary Medical Center in Caribou, where the tests will be available for use with the migrant farm worker population.

Other studies also have called into question the Abbott tests, including a reported 15 percent false negative rate, Francis Collins, director of the National Institutes of Health, testified before the Senate last week.

Another study, published April 23 in the Journal of Clinical Microbiology, reported a 25 percent variation of positive test results when comparing rapid-fire Abbott tests with slower Abbott tests.

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