TOKYO/NEW YORK :
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 precision when used to quickly diagnose patients.
The FDA issued a public alert Thursday evening, saying that it had become aware of several scientific studies that 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 in less than 15 minutes. 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 2.3% to $89.65 at 12:09 p.m. in New York. The stock is up 3.3% this year to date, in part because the company quickly introduced diagnostic products to help combat the coronavirus pandemic that has killed more than 85,000 people in the U.S.
There have been 15 reports of adverse events tied to the tests, said Health and Human Services Secretary Alex Azar, out of more than 1.8 million that have been run. The agency and the company are studying those cases, which could have stemmed from something as simple as a user error, he said.
“We gotta get to where the evidence is, we gotta get to the bottom of it, but we still have confidence in the test or we wouldn’t have it on the market," Azar said during an interview on Fox Business Friday.
The company said it’s working with the FDA and health care providers to make sure they understand that negative results should be considered just one part of a person’s health history, along with recent exposure to the virus and signs and symptoms of Covid-19. It is also re-emphasizing the proper way to collect and handle samples, as some tests are being run in ways the device wasn’t intended to be used, the Abbott Park, Illinois-based company said in a statement.
Accurate test results are important for understanding and controlling the outbreak, particularly since they are used to help guide personal behavior. Someone who is erroneously told they aren’t infected may have a false sense of security and could infect others if they don’t take precautions. False-negative results can also impede efforts to identify patients and trace 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 high sensitivity 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.
Abbott acknowledged in its statement that some studies have raised questions about how accurate the test is, though it previously said users have reported false-negative rates of only around 0.02%. It is continuing to improve on the test as the world learns more about the virus, the company said.
“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 features.