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The head of Maine’s Center for Disease Control and Prevention said Tuesday the agency is double-testing some negative coronavirus tests produced by a rapid-results kit after reports that the test may be among the least accurate in circulation.
Research from the Cleveland Clinic medical center in Ohio found that the Scarborough-made Abbott Laboratories test kits — which gained national attention because they promised to produce a positive test in less than 5 minutes and 13 minutes for a negative test — have a false-negative rate of 15 percent, NPR reported Tuesday. That means the test could miss 15 out of 100 positive cases of the coronavirus.
It was the least reliable test of the five tests the study evaluated, including the CDC’s tests and a test created by Cepheid that is said to produce results in under an hour.
Maine CDC Director Nirav Shah said his agency has been aware for a “couple of weeks now” that the test’s results have “raised flags.” To combat the uncertainty, he said he has advised health care providers using Abbott’s test kits to treat patients as if they tested positive if they receive a negative result for patients they are reasonably sure have COVID-19.
In the meantime, the CDC is also asking those providers to send batches of negative tests so the Maine CDC’s own laboratory can double-check, Shah said. The Cleveland Clinic study found CDC-produced tests were accurate 100 percent of the time.
“The positive results are the ones we have faith in,” Shah told reporters Tuesday. “But the negative results, they have a bit of a question mark.”
The federal Food and Drug Administration gave an emergency use authorization to the test kits, meaning the federal agency allowed the tests to be used during the pandemic even though it did not formally approve the product.
An April 15 statement from Abbott acknowledged that the test’s results may be diluted if the sample is transported in a liquid solution called a viral transport media — the method the Cleveland Clinic used in its trial to transport samples — as opposed to when the swab is placed directly in the testing machine. When administered correctly, a spokesperson said, the test “is performing as expected.”
The tests were heralded as a way to quickly eliminate possible coronavirus cases in the state, but their initial rollout was muted. Maine was supposed to receive 15 testing machines and 150 of the kits; but it received only five kits overall. The state had to seek donations from Martin’s Point Healthcare to get more test kits, according to Maine Public.
Watch: Maine CDC press conference, April 21