The Food and Drug Administration has concerns about the accuracy of a well-known coronavirus test endorsed by Gov. Ron DeSantis and used in area hospitals.
The federal regulator issued a warning Thursday that Abbott Laboratories ID NOW test could be giving inaccurate results. The test received emergency use authorization - somewhat like preliminary approval - in March.
A small study this week from New York University found the test returned false negatives for more than one-third of samples compared to Cepheid’s test. The study has not been peer reviewed. When researchers used a different type of nasal swab to collect material, the test missed nearly half of the positive cases, according to the study.
The FDA reports there have been 15 reported problems with the test. The company has shipped out 1.8 million tests. In part, it’s so popular because of the quick turnaround time of five to 15 minutes.
“We're seeing studies conducted to understand the role of ID Now in ways that it was not designed to be used,” wrote Abbott spokesperson Darcy Ross. “In particular, the NYU study results are not consistent with other studies,” pointing to studies showing 90% and 94%.
Ross wrote to NBC 6 that the company will provide more information and guidance about how to properly use the test, including proper sample collection and handling instructions.
U.S. Health Secretary Alex Azar said Friday the rest could be missing infections because of “user error.” He told Fox Business Friday that the White House continues to have “confidence in the test.”
“We wouldn’t have it on the market,” Azar said, if the federal government didn’t believe it worked.
“The FDA is sharing early information available about potential inaccurate results in the spirit of transparency,” the FDA caution states, noting people’s test results “should be confirmed with another test.”
The Trump Administration has touted Abbott’s test. That political support trickled to Florida, where DeSantis backed the test publicly and helped guide the test to local hospitals.
However, one major hospital system in South Florida has already moved on. Lidia Amoretti, a spokesperson for Jackson Health, tells NBC 6 they switched to a different type of test.
“We did briefly use the Abbott platform, which Gov. DeSantis helped us obtain with some generous partnership from Cleveland Clinic. We identified some issues with the accuracy, which is to be expected when the medical science is so new and evolving so quickly around this virus,” Amoretti wrote. “The best fit for Jackson was to transition to other testing platforms that have high-quality accuracy rates and quick turnaround times for results.”
Cleveland Clinic has not yet responded to a request for comment.
DeSantis’ administration has since switched to a rival test - which can detect antibodies in someone’s blood - made by Cellex, according to the Florida Health Department.
This is the latest testing hurdle the country is going through. After slowly getting diagnostic tests to the public, the federal government has had a hard time controlling a vast supply of antibody tests from crashing into the market. Many of these tests simply are not supported by the science. The FDA has only approved 12 under emergency authorized use.
“The pendulum swung a little heavily, I think, in the other direction. The FDA allowed lots of tests on the market. They’ve pulled that back. So you want to be sure the test that you’re getting, especially the antibody tests, are tests that are approved by the FDA,” said Peter Pitts, a professor and former FDA associate commissioner. “Don’t go on the internet. Don’t order tests yourself. There are a lot of shysters out there selling counterfeit and false products that are only going to do harm.”
Pitts recommends consulting your personal doctor before attempting to get a coronavirus test.
Miami-Dade Commissioner Daniella Levine Cava tells NBC 6 this is another example of the reason for a county Chief Medical Officer who can encourage policy and practice in South Florida, instead of having it come down through presidential endorsement and the free market.
“We can start by putting blame at the federal level. That being said, it shifted to the states and local governments to try and figure it out on their own,” she said.