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Just days after approving antibody tests for coronavirus in Irvine, the city council could have a vote to revoke the decision.
On Tuesday, the council approved city staff’s proposal to order 1,000 antibody tests from US Health Fairs, a nonprofit health group started in February.
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The tests come at a cost of $10,000 for the city, and US Health Fairs will reimburse the city for the tests after they are administered to the general public.
The antibody, also known as serology, tests are different from the tests hospitals use to diagnose active infections, which are known as molecular or PCR tests.
Those tests are approved by the FDA, and Irvine ordered a drive through testing site for its residents in the Great Park with PCR tests from the same contractor.
The drive through facility will cost the city $95,000 and will remain in place for six months, and residents will be able to get tested for free, with or without insurance according to the city council.
The antibody tests are available at a cost of $10 per person and are optional. The city has to order the tests in advance and front the money as it could take up to three weeks to order new ones according to US Health Fairs’ presentation.
The tests ordered by the city are not approved by the U.S. Food and Drug Administration (FDA) according to US Health Fairs.
“The antibody test doesn’t have emergency use authorization,” said Dr. Camellia Babaie, a US Health Fairs medical director, during the council’s discussion. “But it does not mean that companies can’t develop and distribute these tests, it just means the FDA hasn’t given it their official seal.”
Babaie also stated that the tests they are using have only been examined by the lab manufacturing them, with no outside opinions or analysis.
“(Labs) all have the license to develop tests,” Babaie said. “It’s an issue of relying on their own reporting of how accurate the tests are. I vetted a lot of these tests. The one we chose to use reports they have 93% (accuracy).”
Babaie said that no “point of care,” tests with approval from the FDA, and that the only antibody test approved requires doctors to take blood directly from a vein.
However, some councilmembers were confused over what approvals the tests had when they voted unanimously to approve the contract.
Mayor Christina Shea said that when she voted she believed the tests had emergency use authorization from the FDA.
“I will be sending in an email stating I will be pulling my support from allowing Antibody testing without this temporary approval,” Shea said in a text to Voice of OC reporters this morning.
Councilwoman Melissa Fox said that she understood that the tests were not FDA approved when the council voted, but that she was unsure whether she would vote to continue the order for the antibody tests.
“Just to be really clear, Irvine is not offering the testing. We’re not paying for it. We are allowing people to separately pay for those tests if they choose, and they will be given the information,” Fox said.
Fox said that US Health Fairs would prepare disclosure papers for any residents interested in taking the antibody tests, including a disclosure of the test’s accuracy and its lack of approval by the FDA.
”You’re torn between trying to be helpful with the city’s residents and fostering a false reliance or sense of safety based on results of a test we don’t know what the conclusions we can draw from,” Fox said.
US Health Fairs spokesman BC Solomon said that the antibody test offers supportive information, but that the essential test is the PCR test that US Health Fairs will also be giving to residents.
“It’s ancillary, supporting information. It is not the real time diagnostic information that you need to know that you have the virus at present,” Solomon said when asked what information the antibody test offers. “If you want to know if you ever encountered the virus at all, if you’re willing to pay a few dollars you can find that information.”
The antibody tests have also faced growing criticism from county health experts, who say the tests could give people a false sense of security or immunity.
County health director Dr. Clayton Chau said that the antibody tests have value only from an academic perspective at a press conference on Thursday afternoon.
“The CDC said it’s really not recommended because there’s no use, there’s no usefulness to the individual serology testing because it doesn’t tell you that you’ve developed immunity,” Chau said. “In fact, there are people who have been infected that recover and get infected again.”
Councilmembers Farrah Khan, Mike Carroll and Anthony Kuo did not return requests for comment.
Noah Biesiada is a Voice of OC Reporting Fellow. Contact him at firstname.lastname@example.org or on Twitter @NBiesiada.