Weeks after the U.S. Food and Drug Administration granted emergency use authorization of the Chembio Diagnostic System Inc. COVID-19 antibody test, the FDA revoked nationwide authorization, halting a Utah health solutions company’s rapid antibody testing.
The FDA revoked emergency use of the Chembio antibody test on Tuesday, June 16, due to performance concerns involving the accuracy of the test’s results.
The Chembio antibody test was one of the first authorized by the FDA after the agency determined the test met its criteria to be held at “may be effective” standards and concluded the test’s known and potential benefits outweigh its known and potential risks. These conclusions were made based on information provided by Chembio.
As the FDA received more information, the agency was able to develop performance expectations for antibody tests, which Chembio tests allegedly did not meet. According to data submitted by Chembio and an independent evaluation of the tests by the National Cancer Institute, it was discovered that Chembio tests yielded a higher-than-expected rate of false results.
Due to the discrepancies in Chembio testing results, the FDA revoked its emergency use authorization nationwide.
“Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test, including the high rate of false results,” according to a press release by the FDA.
Layton-based RapidScreen Solutions had been using the Chembio tests to promote antibody testing in Salt Lake and Utah counties.
Paul Benson, an oral and maxillofacial surgeon as well as the head of RapidScreen Solutions, said the company has had consistent results with the Chembio test, asserting that the tests showed an almost 100% consistency from the results that were retested.
“Whenever there was a doubtful test, we retested,” he said. “We were getting very consistent results with that. It makes us wonder what the issues were that the FDA was seeing that led to it being revoked. Regardless, we need to follow their guidance. They’re out there to protect the public, and that’s our No. 1 priority.”
RapidScreen Solutions is now taking pause, regrouping and looking for alternative routes to continue its testing efforts for Utah communities. Testing kicked off toward the end of May, beginning with four cities, including Draper, Riverton, Bluffdale and Vineyard.
Benson said before long, the company was expanding testing to Lehi and other Utah County locations, charging $79.99 for a finger-prick test that could provide results onsite.
RapidScreen Solutions was able to host one day of testing in Lehi before the FDA revoked its emergency use authorization of Chembio tests.
“It’s not difficult to move from test-to-test,” Benson said. “We just want to make sure that we go through the whole process again of evaluating the other tests on the market before we just jump right back into the saddle.”
The company has other tests that it has immediate access to, but Benson said RapidScreen Solutions wants to go through its own system of internal investigations before moving forward for the sake of using what they have.
The other tests RapidScreen Solutions has access to have also already been granted emergency use authorization by the FDA.
COVID-19 antibody testing is a matter of public health and safety, Benson said. While the nasal swab is a superior test, however it has some limits, such as its short testing windows and its inability to determine if an individual has been exposed to the coronavirus in the past.
If someone is exposed to the coronavirus, antibodies from the virus persist in the blood. Months after the virus has passed, a swab test is not effective anymore, but an antibody test is.
In recent weeks, people who have tested positive for COVID-19 antibodies are donating their plasma to help health professionals treat people hospitalized with COVID-19 using convalescent plasma, Benson said.
“There’s value in finding who in the community might be able to donate their plasma to help those who do get the disease, especially as we’re seeing an increase in the disease right now,” he said.
Additionally, antibody testing could give healthcare professionals some insight into a pattern of immunity by revealing those whose immune systems have successfully fought off COVID-19 as well as those who were asymptomatic.
RapidScreen Solutions has seen an incredible demand for antibody testing, Benson said, especially because of the high number of people who were experiencing symptoms in January and February but who were unable to get access to the COVID-19 test at the time.
These tests, he said, do not make up for all of the good that social distancing and wearing a mask can do in social situations, Benson said, especially with the recent increases in COVID-19 confirmations in Utah.