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

The FDA is looking into inaccuracy reports.
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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.

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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. 

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