An Abbott Laboratories COVID-19 test has potential accuracy issues, the U.S. Food and Drug Administration warned, citing a number of studies that have raised doubts about the product’s ability to quickly diagnose patients.
The FDA issued a public alert Thursday evening, saying that it had become aware of several scientific studies that had raised questions about the device, a printer-sized machine called ID Now that can take a sample from a nasal swab and diagnose a coronavirus infection. The agency said that it was particularly concerned about false-negative results, in which an infected person is told by the test that they don’t have the disease.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.
Abbott shares fell in late trading, dropping 3.6% after the market closed in New York. The stock is up 5.7% this year to date, in part because of the company’s rapid deployment of diagnostic products to help combat the coronavirus pandemic that has killed more than 85,000 people in the U.S.
Accurate tests are important for doctors and health workers. A patient with a false-negative diagnosis might not take precautions and could infect other people around them. False-negative results can also impede efforts to identify patients and track their contacts, a key part of expanding efforts by states to track and contain the virus as they reopen businesses and lift social distancing rules.
The FDA said that the Abbott test, which has been used at the White House, can still be used to diagnose positive results, often within minutes. But it warned that a negative result might need to be confirmed with a different test to be certain the person doesn’t have the virus.
The FDA’s alert comes as research is raising more questions about tests used around the U.S. to diagnose COVID-19 patients. One study released this week from researchers at New York University examining the Abbott machine indicated it may miss as many as half of positive cases.
In a statement, Abbott Park, Illinois-based Abbott said some of the studies had used the machine in ways that it wasn’t intended to be. But the company acknowledged that some studies had shown rates of false negatives as high as 20%, far greater than the 0.02% that users had previously reported.
“While we understand no test is perfect, test outcomes depend on a number of factors,” Abbott said in the statement. The company said that sample handling, storage and transportation could all affect performance, as well as other factors. The company said it was in contact with the FDA, and was examining how the test performance could be improved.
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