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Law360 (May 15, 2020, 3:14 PM EDT) -- The U.S. Food and Drug Administration on Thursday said early data suggests potential accuracy problems with an Abbott test for COVID-19 that may return false negatives.
The agency said some scientific studies have identified accuracy issues with Abbott's ID NOW test and it is looking into whether it could be due to the types of swabs used or how specimens were transported. The agency emphasized that these studies do have limitations, such as small sample size, and that tests might not have been carried out following the instructions.
The FDA said it is investigating 15 adverse event reports of false negatives and it is working with Abbott to analyze the information. It also collaborated with the company to send a letter alerting that negative tests results inconsistent with a patients' symptoms should be confirmed with another test.
The agency also noted that these reports can be incomplete or inaccurate, so its staff has to comb through the reports to find data to support any patterns about how the test is used.
"This test can still be used and can correctly identify many positive cases in minutes," Tim Stenzel of the FDA's center for devices said in a statement. "Negative results may need to be confirmed with a high-sensitivity authorized molecular test."
According to the FDA, no diagnostic test will be 100% accurate due to user error and specimen handling, so it is important to study patterns and identify the cause of suspected false results to quickly address any important issues.
"The world needs a variety of tests in labs and at the point of care if we are to help reduce the risk people have every day of contracting the virus," an Abbott spokeswoman told Law360 on Friday. "Risk reduction is the goal, which is why we're developing and continually optimizing as many tests as we can across all of our diagnostics platforms."
The spokeswoman also said a recent study from the Detroit health department found that the tests had a 98% accuracy rate.
The FDA said Abbott has agreed to conduct post-market studies for the tests that will include at least 150 patients positive for the novel coronavirus in a variety of clinical settings.
"The information gathered from the post-market studies can further help the agency understand the cause or patterns of any accuracy issues and inform any additional actions the company or the FDA should take," the FDA said. "The FDA will keep working with Abbott to further evaluate these accuracy issues and will publicly communicate any updates."
As of May 11, Abbott has shipped more than 1.7 million of the tests to all 50 states, Washington, D.C., Puerto Rico and the Pacific islands, with the majority going to outbreak hotspots, according to the company's website.
The company said it is making 50,000 tests a day with plans to expand manufacturing capacity to 2 million tests a month by June.
--Editing by Stephen Berg.
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