Apopka halts antibody testing after FDA pulls authorization for test kits
Tests not currently FDA-approval after policy change last week
The antibody testing site in Apopka closed this week after Mayor Bryan Nelson said he got word the tests the city bought had their Food and Drug Administration approval temporary reversed following a change by the Food and Drug Administration last week.
“What’s happened is the FDA has pulled all of the emergency use authorization for the test kits, there are hundreds of them out there,” Nelson said. “So we are just waiting for them to give us approval again to use those tests.”
Apopka had distributed 300 kits at the site which was open Monday, Wednesday and Friday at the Apopka Community Center. The site closed within the first hour as several residents wanted to know if they had antibodies for COVID-19.
Now, it will be closed until the left over test kits the city purchased, about 115 of them, get approval by the FDA.
According to the FDA, it was a change in a policy the administration had put out in mid-March loosening restrictions for companies so they can get anti-body testing into the market. Nelson saying he’s noticed the supply skyrocketed over the last few weeks.
"It's funny because the cost of the kits have come down considerably since the first ones," Mayor Nelson said. "They were $50 dollars a kit, the second batch we bought were $30 dollars a kit and now we are talking less than $15 dollars a kit."
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The FDA said antibody testing is important, however, the administration said companies have flooded the market and some test kits are fraudulent, which is why they have changed the policy.
“In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis, a fact that remains true today. However, flexibility never meant we would allow fraud,” the May 4 news release said.
Now, the FDA is requiring test developers to get stricter approval through their administration.
Under this revised policy, the FDA has outlined the following expectations for antibody test developers: Commercial manufacturers will submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing or from the date of this policy, whichever is later.
Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
The release said they are also working to streamline the approval process.
Nelson believes the tests the city has will be approved soon and hopes to have anti-body testing back up and running in Apopka as early as Monday. As for the 300 residents who received the testing last week, he believes the test they have are accurate and reliable.
“I think they are reliable,”Nelson said. “The numbers we are looking at are very bit as good between 97%-99% accurate.”
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