ORLANDO, Fla. – The U.S. Food and Drug Administration is raising a red flag about a type of rapid coronavirus test being used in Florida.
Abbott Laboratories’ “ID NOW Point-of-Care” rapid coronavirus tests is under investigation by the Food and Drug Administration after data suggested the 15-minute tests could miss COVID-19 cases, falsely clearing people with the virus.
FDA Commissioner Steve Hahn said Friday his agency has provided new guidance to the White House after data suggested that a rapid COVID-19 test used by President Donald Trump and others every day may provide inaccuracies and false negatives.
Hahn said that if a person is suspected of having the virus, “it might be worth, if the test is negative, getting a second confirmatory test. That’s what our guidance is about.”
According to the FDA, in some cases, the test may return false-negative results. Meaning it can falsely reassure patients they are not infected with the virus when they actually are.
Florida Lt. Gov. Jeanette Nunez told News 6 the state is looking into the matter.
"We know that there are Abbott tests throughout the state of Florida," Nunez said.
"When you have something from the FDA that questions the veracity, then obviously we're going to have to take a look at that and continue to monitor that," she said.
“The test can still be used and can identify many positive cases in minutes ... but negative results may need to be confirmed with a high-sensitivity authorized molecular test,” according to the FDA news release.
Nunez says the tests are used in Florida, but she doesn't know to what extent.
Last month, Gov. Ron DeSantis said some Jacksonville-area hospitals had received the Abbott ID NOW testing kits but he would like all Florida hospitals to have the 5-minute testing machines calling the technology “a game-changer."
“I don’t have specific information as to the amount of Abbott tests we have on-site in any of our facilities in any hospitals. I know some hospitals do have them,” Nunez said.
Abbott Laboratories also released a statement that some hospitals and labs have been using a liquid solution with the test when they should not.
This method can reduce the sensitivity of the test through dilution which can potentially lead to false-negative results, the company wrote in a news release.
“Is it a protocol issue? Is it an issue about how the test was conducted? I think there’s a lot of question marks but of course, that’s something we’re going to take a look at very closely,” Nunez said.
News 6 contacted healthcare systems across Central Florida to see if they use the tests.
Orlando Health was the first to respond. Here is their full response:
“Orlando Health currently uses the Abbott ID NOW testing system when more timely results are needed prior to an emergency or elective surgery or procedure. Since the start of using the system, our team has taken specific steps in the testing process to ensure the highest level of accuracy. In reviewing the manufacturer’s response to possible accuracy concerns, we confirmed our protocols have always reflected the specimen collection practices that are now being recommended. As with all diagnostics, medications, treatments, protocols, and policies related to COVID-19, we will continue to seek best practices, remain informed, monitor, and make adjustments as necessary to keep patients and team members safe.”