Fond du Lac Band stops using COVID-19 test over accuracy concerns

The FDA is looking into inaccuracy reports.
Publish date:

Fond du Lac Band of Lake Superior Chippewa has stopped using a COVID-19 test that gave fast results due to concerns over the test's accuracy.

The band has been using the Abbott ID NOW test that provides results in fewer than 20 minutes, as well as a test through Mayo Clinic that provides results in 1-5 days. But concerns were raised last week regarding the Abbott ID NOW test, which prompted the band to reevaluate using the test, the band posted on Facebook Tuesday.

"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 post said. 

On May 14, the U.S. Food and Drug Administration (FDA) issued an alert that said the Abbott ID NOW test may return false-negative results, with Tim Stenzel of the FDA noting the test can still be used and can correctly identify "many positive cases in minutes," but "negative results may need to be confirmed with a high-sensitivity authorized molecular test." 

The band said not all patients who received the Abbott ID NOW test will need to be retested. It has called and reassessed patients who were tested with this test over the last 14 days and scheduled additional testing when appropriate, which will be sent to the Mayo Clinic Laboratory for testing, the post said. 

During public health emergencies like we're going through now, the FDA will authorize the use of unapproved medical products in emergency situations when no adequate and approved alternatives are available, the band said, noting this is the case "with all COVID-19 testing."

Abbott Laboratories, based in Illinois, said it has been working closely with the FDA throughout the Emergency Use Authorization (EUA) process, noting some "studies being conducted to understand the role of ID NOW in ways that it was not designed to be used," a May 14 news release says. Abbott mentions the NYU study, which prompted the FDA's alert, stating the results "are not consistent with other studies."

"While we've seen a few studies with sensitivity performance percentages in the 80s, we've also seen other studies with sensitivity at or above 90 percent, and one as high as 94 percent," Abbott said.

Sign up for our BREAKING NEWS newsletters

In total, the FDA has received 15 adverse event reports about the Abbott ID NOW test and it is reviewing the reports, the alert said. It is looking into these and investigating whether false negative results could be due to the types of swaps or viral transport media that were used. The FDA said external studies, like the NYU study, are just one piece of the FDA's overall evaluation of a diagnostic performance. 

In response to accuracy concerns, the FDA says Abbott has agreed to conduct post-market studies for the test that will include at least 150 COVID-19 positive patients in a variety of clinical studies, which can help the FDA and Abbott understand the cause or patterns of accuracy issues and inform what steps need to be taken. 

Abbott in its May 14 update said it will further clarify product information, noting negative results should be presumed negative unless it is inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay. It is also reinforcing proper sample collection and handling instructions. 

As of May 11, Abbott said it had shipped more than 1.7 million ID NOW tests to all 50 states, with the majority sent to outbreak hotspots, and it is manufacturing 50,000 tests per day with the goal of increasing the manufacturing capacity to 2 million tests a month by June. 

Next Up

CBP heater

More than $260K in fake heaters seized at Minnesota border

The 780 infrared zone heaters were found in a rail car bound for Ranier, Minnesota.

Ian Cole

Wild trade Greg Pateryn to Avalanche for Ian Cole

Cole won a pair of Stanley Cups in Pittsburgh and is a former first-round pick.


St. Croix County GOP chair resigns after incendiary post on official website

John Kraft sparked controversy with his 'Prepare for War' post on the party website earlier this month.

ann kim

Ann Kim's new restaurant, Sooki & Mimi, to open in February

The James Beard Award winner is the brains behind Young Joni, Pizzeria Lola, and Hello Pizza.

Screen Shot 2021-01-19 at 1.32.19 PM

Firefighters rescue worker after trench fall in Rochester

The construction worker fell about 15 feet.

gray wolf

Grand Marais mayor's dog survives attack by wolves

He heard his 65-pound dog "screaming bloody murder" and then saw the wolves chasing her.

Screen Shot 2021-01-19 at 12.04.55 PM

Minnesota's COVID vaccine appointment site goes live

Huge demand was expected when the site went live at noon.

emily ford

Duluth woman is hiking 1,000-plus miles on the Ice Age Trail this winter

She could be the second person ever to finish a winter-thru hike of the Wisconsin trail.

coronavirus, covid-19, icu

Here is Minnesota's COVID-19 update for Tuesday, January 19

Two days in a row with fewer than 1,000 new cases.


coronavirus, covid-19, drive-thru testing

Here are the 6 latest locations for free COVID-19 testing in Minnesota next week

MDH is conducting the testing amid increased community spread in Minnesota.


Minnesota offering free COVID-19 tests at 6 places this weekend

The testing sites have the capacity to test 6,000 people this weekend.

Fond du Lac Band to choose leader Tuesday

Voting members of the Fond du Lac Band of Lake Superior Chippewa will choose the next chair of their Reservation Business Committee. The position oversees a budget of about $180 million and businesses, including a casino amid a legal battle with the city of Duluth. Pete DeFoe is challenging incumbent Karen Diver for the four-year term.

City of Duluth files lawsuit to stop Fond du Lac Band from expanding its downtown casino expansion

Duluth claims the tribe breached its contract with the city. The News Tribune reports the band is seeking federal authority to expand its downtown gaming activities to include a former hotel without obtaining approval from the city.

3M coronavirus test

3M developing paper COVID-19 test to give results in minutes

This test could be administered at the point-of-care and wouldn't need to be sent to a lab to get the result.

Judge tosses out Duluth's lawsuit against Fond du Lac band

Duluth maintains the band needs city approval before expanding its reservation at Fond du Luth casino to include an adjacent hotel. The city attorney says a St. Louis County judge dismissed the lawsuit because a federal court is a better venue for it.

coronavirus, covid-19, drive-thru testing

Here are the 4 free COVID-19 testing sites in MN for the week of Oct. 19

People don't need to have symptoms or insurance to get tested for free.