The CDC sent novel coronavirus testing kits to Florida. They might not work
Florida health officials received testing kits for novel coronavirus earlier this week but can’t use them yet because it’s unclear whether the tests are working.
The U.S. Centers for Disease Control and Prevention on Wednesday morning said issues with the tests the agency has developed for the respiratory illness spreading rapidly through China surfaced after they were sent out to state labs.
After state labs receive testing kits from the CDC, they must verify their accuracy, but the labs flagged “inconclusive results,” or returns that were neither positive nor negative, CDC officials said on a call with journalists Wednesday.
Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said federal officials believe the issue stems from one substance used in the test that “wasn’t performing consistently.” She said the federal agency was remanufacturing that agent to try to correct the problem.
“Obviously, a state wouldn’t want to be using this test and using it to make clinical decisions if it isn’t working as well at the state as it is at CDC,” Messonnier said.
As of Tuesday, there were more than 43,000 global cases of the virus, now known as COVID-19 — about 42,700 of them in China — and more than 1,000 deaths, with all but one of the fatalities in China, according to the World Health Organization. The CDC confirmed one additional U.S. case of COVID-19 on Wednesday, bringing the total number of cases in the U.S. to 13.
It’s not yet clear which states would need additional testing kits, but Florida may be among them. State officials on Tuesday evening said they received the testing kits at all three of their labs, including one in Miami, but were told by the CDC to hold off on using them until questions over their accuracy are resolved.
The Florida Department of Health is currently sending specimens to a CDC lab in Atlanta and waiting for results, which can take three to five days. That lab is handling specimens from across the country.
The state health department has so far not shared information about how many people in Florida have been tested and how long it has had to wait for results. The agency reiterated on Wednesday that so far there are no confirmed cases in Florida. Experts believe the disease is spread from person to person, but questions remain about the incubation period — when patients show no symptoms but may still be contagious.
The kits sent to state labs can each be used to test hundreds of samples. Messonnier said on Wednesday that the state labs do not use actual specimens suspected of containing the virus in evaluating the testing kits.
At a U.S. Senate committee hearing Wednesday addressing the threat of global pandemics, former federal health officials said they are concerned about how long it has been taking to test for local novel coronavirus cases, adding that state health departments should not be relying on sending specimens to federal labs and waiting days for the results to come back.
Ideally, federal officials would be able to ship portable test kits to U.S. hospitals and physicians, said Scott Gottlieb, who was the Food and Drug Administration commissioner from 2017-2019.
“We should be trying to find it in the community,” Gottlieb said, at the hearing held by the U.S. Senate Committee on Homeland Security and Governmental Affairs. “That’s how we’re going to spot small outbreaks and prevent them from becoming larger outbreaks.”
Gottlieb said he anticipated those small outbreaks would start to surface in the U.S. in the next two to four weeks. Federal health officials, he said, should be monitoring cities and neighborhoods with large immigrant populations.
Luciana Borio, director of medical and biodefense preparedness at the National Security Council from 2017-2019, said it was important to have faith in the portable testing kits before they could be relied upon in a public health emergency. She highlighted concern about the accuracy of certain swab tests being used in China — it’s unclear whether the swab tests used in China are the same ones being sent out by the CDC — and the preparedness of the U.S. healthcare system’s ability to take care of patients when more cases surface
“We have to assume that we’re going to see a lot more cases here,” Borio said.
At the hearing, Florida Republican Sen. Rick Scott said his biggest concern is a lack of FDA inspectors in China to monitor the quality of medications being manufactured there and distributed around the world. The federal agency announced this week that it suspended inspections of Chinese drug manufacturing facilities due to the outbreak.
“That’s concerning because then we have a lot of things coming to our country that are not being inspected,” Scott said. “When you hear something like that, that we don’t have inspectors there, what risk are we taking? They ought to tell us so then as a consumer you can say, ‘I don’t want to buy that product right now because it’s not being inspected.’ ”
No current federal health officials spoke at the Senate committee hearing on U.S. preparedness for global pandemics. U.S. Sen. Kamala Harris, a California Democrat, raised that fact, and said she was told that the CDC would have had to prepare talking points, which she said was not a sufficient explanation.
“The American people deserve them to be here this morning,” Harris said.
Miami Herald staff writer Alex Daugherty contributed to this report.
This story was originally published February 12, 2020 at 1:16 PM.
