Worries over potential inaccuracies from a fast-acting COVID-19 test touted by the Trump administration has prompted the Fond du Lac Band of Lake Superior Chippewa to stop using the product, after federal regulators warned the public about it.
Fond du Lac Band shelves instant COVID-19 test amid accuracy concerns
The FDA says the Abbott ID NOW test can return false negatives, but Abbott says it is accurate in its studies.
May 21, 2020 at 3:49AM
"After thorough research and investigation it was decided that the immediate removal of Abbott ID Now from our COVID-19 testing options was necessary, until further research has been conducted," the band announced Tuesday on Facebook. All patients who were tested with the system in the past 14 days were contacted, and additional testing may be done through the Mayo Clinic Laboratory.
Last Thursday, the U.S. Food and Drug Administration said the test, in use at more than 1,000 sites nationwide, may be returning false negative results in some cases.
Illinois-based Abbott Laboratories said its ID Now system is the most widely used point-of-care instrument in the U.S., and was one of the first systems to be granted an emergency authorization by the FDA for use to detect molecular traces of the virus that causes COVID-19. More than 2 million of the tests have been delivered nationwide.
Abbott said the system can positively detect COVID-19 in as little as five minutes, making it the fastest system on the market. The toaster-sized system is intended to be used near the patient after they have given a nasal- or throat-swab specimen. Internal testing showed the system correctly detected COVID-19 in 30 of 30 viral samples, and ruled out detection in 30 of 30 negative samples.
But the system has been criticized for its accuracy.
A comparative, non-peer-reviewed study of samples from 101 patients at New York University Langone Tisch Hospital found what the researchers characterized as "low sensitivity" and "high false negative results."
Abbott said the NYU study that prompted the FDA warning "is an outlier" and the company was reinforcing proper sample collection and handling instructions with users. "We've seen well-conducted studies with accuracy rates ranging from the mid-80s to mid-90s, which is what you'd expect from a rapid point of care test," Abbott spokesman John Koval wrote in an e-mail.
Though the FDA is investigating at least 15 complaints alleging the system delivered inaccurate negative results, regulators do not recommend providers stop using the system.
"This test can still be used and can correctly identify many positive cases in minutes," FDA official Tim Stenzel said in a statement. "Negative results may need to be confirmed with a high-sensitivity authorized molecular test."
Abbott said a negative reading from the ID Now system should be presumed to be accurate. But if that negative result seems inconsistent with other clinical signs or symptoms, the patient should be tested with an alternative molecular assay.
The test is used in urgent-care clinics, physicians' offices, hospital emergency departments, retail pharmacy chains and by the U.S. government. The Associated Press reported the system is used daily at the White House, including on President Donald Trump and his staff.
Asked whether use of the system has dropped nationwide since the FDA communication, Koval said Abbott has seen no such decline.
Several large Minnesota health care providers — including Allina Health, HealthPartners, Essentia Health and St. Luke's — said they don't use the Abbott test.
Pharmacy giants CVS and Walgreens have set up testing sites that use the ID Now test, but the chains don't offer the service in Minnesota.
The Fond du Lac Band opened drive-through testing late in April using the ID Now test for high-risk patients and sending other samples to the Mayo Clinic. The band will shelve the instant test "until further research has been conducted from Abbott Laboratories and the FDA verifying its accuracy of its device."
The band's medical director, Dr. Charity Reynolds, said just a couple of patients who were first given the ID Now test needed to be retested, and all came back negative. The band's clinic has not seen a confirmed case of COVID-19 so far.
A majority of the 67 confirmed cases in Carlton County, where the Fond du Lac Reservation is located, are tied to the outbreak among inmates and staff at the Moose Lake prison.
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The governor said it may be 2027 or 2028 by the time the market catches up to demand.
