FDA Strengthens Application of Covid-19 Antibody Tests

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On March 16, the FDA relaxed its standards and allowed companies to sell antibody tests without providing any evidence of their effectiveness.

This has led to “crappy” tests flooding the market, according to Scott Becker, CEO of the Association of Public Health Laboratories.

Dr. Deborah Birx, response coordinator for the White House Coronavirus task force, called the antibody tests “critical” in the response to the pandemic.

If someone has antibodies, they could be immune to the disease. On a small scale, if a person is immunized, it can help them make decisions about returning to work and returning to the community. On a larger scale, knowing what percentage of the population is immunized can help officials make decisions about reopening the country.

It is crucial that the tests work properly. A false positive – telling someone that they have antibodies when they don’t – could have serious consequences, because they would think they were immune to Covid-19 when they were not.

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“A test is only as good as its result,” said Kelly Wroblewski, director of infectious disease control programs for the laboratory association, which represents more than 125 state, county and county public health laboratories. municipalities in the United States. “Having many inaccurate tests is worse than not having any at all. “

During Tuesday’s call, Becker said FDA Commissioner Stephen Hahn had told him and his association members that the National Cancer Institute (NCI) would begin examining the tests that are on the market to see if they were getting correct results.

“I am glad they took these steps,” Becker told CNN after the call.

“We hope that the evaluation will be completed very soon and that this data will be available, so that we can get an idea of ​​the quality of these tests,” added Wroblewski.

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In recent interviews, Hahn spoke of the need to review the tests.

“I am concerned that some of the antibody tests that are on the market and that have not been subjected to scientific review by the FDA may not be as accurate as we would like,” he said. he told NBC on Sunday “Meet the Press”. . “I can assure the American people that what we are doing is using data and science to examine these tests to make sure they are valid, accurate and reproducible. “

More than 90 companies have informed the FDA that they are selling antibody tests. Becker said it is not clear how many tests the NCI will review to see if they work.

He said members of his association, which represents more than 125 state, county and municipal public health labs in the United States, would have preferred the FDA to change the rules so that companies would have to provide data showing let their tests work.

“The valves have been opened and now the consequences of this are becoming evident,” he said. “Now they’re putting in place flood control measures to check for accuracy. It would have been ideal if these measures were in place in the first place, but it is a good step given where we are in this pandemic. “

The FDA did not answer questions for this story, referring CNN to the NCI.

Minali Nigam contributed to this story.

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