The U.S. Food and Drug Administration has issued an alert about possible false negative results associated with Curative's COVID-19 tests, which are commonly used nationwide, including in Chicago.
The FDA offered no information on what triggered the so-called safety communication Monday, but it appeared to be about the test’s accuracy for people who don’t exhibit COVID-19 symptoms, such as fever, sore throat and fatigue.
To reduce the risk of false negative results, the agency said, the test must be performed as described in authorized labeling. The faulty results pose the biggest risk from a health perspective because people who are erroneously told they don’t have the virus can unknowingly spread it.
In a statement, the Chicago Department of Public Health said it has no evidence to be concerned about the population-level performance of the test at its community-based sites.
A spokesperson added that CDPH is aware of the FDA communication and has reached out to both Curative and the FDA for additional details.
If a patient has tested negative, but suspects they may be infected and have questions related to their test, CDPH encourages them to reach out to Curative or call their healthcare provider.
No test is 100% accurate and even the most sensitive are expected to deliver a small percentage of false results. Most of the molecular tests authorized by the FDA, including the Curative test, are expected to catch upward of 95% of COVID-19 cases.
All COVID-19 tests on the U.S. market have been quickly developed and rushed through testing to respond to the pandemic. Under “emergency use authorization,” companies such as Curative needed only show a test “may be effective,” a lower bar than the FDA’s standard under normal conditions, requiring study data showing “safety and effectiveness.”
Curative was founded just a year ago by British wunderkind, Fred Turner, then 25, who was making sepsis tests and pivoted to the coronavirus when the pandemic struck.
He developed an easy-to-use method that collected a specimen by swabbing the inside of the mouth after coughing. The test didn’t require the nasal swabs that were in short supply and had created a bottleneck at a time when more testing for COVID-19 was desperately needed.