FDA: COVID-19 tests city is using may give false negatives
Chicago’s public COVID-19 testing sites for months have been using test kits that the Food and Drug Administration warned this week should not be used on people who don’t experience symptoms.
The Curative tests have been used since last spring at city testing sites, where Chicagoans who aren’t showing coronavirus symptoms can get tested.
On Monday, the FDA issued a directive “alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-CoV-2 test.”
“Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events,” the FDA directive reads in part.
The city has partnered with Curative since the spring to run testing sites around Chicago, with no requirement that people who come in for the tests be showing symptoms. People whoare about to travel, who worry that they’ve been exposed to someone who has COVID-19 or who are planning to see at-risk family members often will get tested even if they aren’t showing symptoms.
Thecity’sCOVID-19 testing website says anyone who has had a “high-risk exposure” is eligible to get tested.
Those infected with COVID-19 can transmit it to others before they start showing signs, so a false negative test result could lead peoplewhodon’t know they have it to spread it.
The FDA notes that the instructions for the Curative tests say it should only be used on “symptomatic individuals within 14days of COVID-19 symptom onset.”
The Chicago Department of Public Health on Friday issued a statement that said the agency is aware of the FDA statement and reached out to the FDA and Curative “for further details.”
But the department expressed confidence in the Curative tests. “CDPH closely monitors the results of Chicago’s communitybased testing program, and currentlyhas no evidence to be concerned about the population-level performance of this test at Chicago community-based sites,” the statement reads in part.
The health department did not respond to questions about how many asymptomatic people have received the Curative tests since the city started administering them.
In a statement, Curative said the company’s tests are “labeled with specificwarnings, precautions, and limitations that FDA reiterated in the Safety Communication.”
“The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance,” the statement reads in part.
Mayor Lori Lightfoot in May announced the city would partner with Curative to expand community testing, focusing on the hardest hit areas of the city.
In November, Lightfoot announced Curative would be helping the city prepare for the winter at the community testing sites in response to a local surge in coronavirus cases.
ABC News reported on Friday that the city of Los Angeleswould continue using the Curative test in spite of the FDA directive, but that the U.S. Congress would seek a new test.