Orange County health officials and experts are raising concerns about the city of Irvine’s plans for drive-through antibody testing, saying such tests are not recommended for individual results at this point because they can inaccurately suggest people have immunity to coronavirus, on top of having accuracy problems.
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The antibody tests, also known as serology tests, are different from the tests hospitals and doctors use to diagnose individual people’s active infections, which are known as molecular or PCR tests. It’s the PCR tests that health experts recommend expanding in order to re-open more of the economy.
Antibody tests show if a person has previously been infected with a coronavirus, and can help estimate how much of the entire population previously had COVID-19, when testing is done through random sampling.
But medical experts and the county are cautioning cities about individual-level antibody tests as part of re-opening efforts, when much is still unknown about immunity and current antibody tests are giving higher rates of false positives.
“I would caution them, and I will tomorrow,” said Dr. Todd Newton, the Orange County medical director for Kaiser Permanente, which is one of the largest health care providers in OC.
“I know they want to open – so do I, by the way,” he added. “But I think people are trying to latch on to these antibody tests…and I don’t believe it’s there yet.”
“That doesn’t mean there’s no value,” he added, noting the role of antibody tests in understanding what share of a population has previously been infected. “But that’s more academic information” than individual-level results, he said.
“The real problem really is the false positive rates of these tests” currently and the unknowns so far around immunity to COVID-19, Newton said.
“There is currently no recommendation from federal, state or local health experts that individuals should get serology tests,” county Health Care Agency spokeswoman Jessica Good said Wednesday when asked about Irvine’s plans.
“The U.S. Centers for Disease Control and Prevention (CDC) suggests that those interested in testing should consult with their healthcare provider to assure they access a FDA authorized test and they fully understand the meaning of the results,” she added.
Irvine’s proposed tests are not approved by the U.S. Food and Drug Administration (FDA), according to the city’s contractor.
Irvine Mayor Christina Shea, when asked about the concerns Wednesday, said there should be disclosure about the tests’ accuracy to people who take it.
“We’re going to have to make sure there’s going to be some type of document people sign so that they understand how accurate these tests are going to be,” Shea said in an interview Wednesday.
“I don’t want people to think they’re going to get 100 percent conclusion, as these false positives could come out.”
Irvine City Manager John Russo didn’t return a phone message seeking comment.
County CEO Frank Kim, who oversees the county health department, said the county currently sees no medical benefit for individuals to know whether they have coronavirus antibodies.
“From a county perspective, we are taking a second look at serology and we want to deploy it in a way that is supported by medical science…Not for the purposes of establishing any kind of immunity or other things, because those things are not supported by medical science at this time. So they’re just unknowns,” Kim said in an interview Wednesday.
“The county, at this time, is not inferring any particular medical benefit to you having an antibody to [COVID-19]. That is unknown.”
People who have tested positive for having antibodies have gotten re-infected with coronavirus, according to the county’s health director, Dr. Clayton Chau. Much is still unknown about how many antibodies people must develop in order to have immunity, and how long immunity lasts, he told county supervisors Tuesday.
“For this virus, so far science tells us that even for people who have gotten COVID-19 [and] have antibodies…they still get re-infected again,” said Chau, director of the Orange County Health Care Agency, at Tuesday’s county supervisors meeting.
“When you tell people to go and get [a] serology test, it really is not a protective [measure]. It’s not a ‘go card,’ ” Chau added. “We don’t want the public to misunderstand that piece and have [an] unsafe presumption that it’s safe to go.”
The antibody tests Irvine plans to contract for are not approved by the FDA, according to the contractor, US Health Fairs, a nonprofit group formed in February.
“The antibody test doesn’t have emergency use authorization,” said Dr. Camellia Babaie, a board member for US Health Fairs who presented to the council. “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.”
Mayors across Orange County have been receiving offers from clinics like US Health Fairs offering drive-through antibody testing, with Irvine being the first city known to have authorized a contract.
The Irvine City Council on Tuesday night authorized city staff to sign a $100,000-plus contract for the nonprofit to provide drive-though antibody and PCR testing.
Irvine’s proposed testing contract was not made public on the agenda before the City Council authorized staff to finalize and sign it Tuesday. City officials declined Wednesday to make the proposed contract public, saying final changes were being made and the contract would be released after it’s signed.
Efforts to reach US Health Fairs through their business phone number were unsuccessful Wednesday.
The City Council on Tuesday authorized over $95,000 for PCR testing and ordered 1,000 antibody tests for $10,000 that would be made available to residents. The council indicated they would purchase more if necessary.
According to a presentation at the meeting, the city will pay for the antibody tests upfront, and will then be refunded by US Health Fairs after residents purchase it, at a price of $10 per test, according to the presentation shown at the meeting.
During questions from the council, Babaie, the US Health Fairs board member, said the antibody tests are not FDA approved.
Babaie added the antibody tests are 93% accurate, based on a review by the lab that created the test.
“Every lab had to conduct its own internal test…they 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.”
US Health Fairs has drive through testing sites in Carson and Pico Rivera, according to WHO. Irvine would be the first city where they administered antibody tests, according to their presentation to the council.
At Tuesday’s meeting, the council approved the drive-through testing along with a new four stage plan to reopen the city, new regulations regarding outdoor dining and a review of summer activities the city would be hosting.
Newton, the Kaiser medical director, said the most accurate current antibody tests have an accuracy rate of 95 percent, and that it would need to be at about 99 percent given the low current prevalence of COVID-19.
Antibody testing likely will become more relevant to individuals in the future, once the tests are more accurate and more is known about immunity, he said.
“We absolutely agree that widespread antibody testing is very likely to play a huge role” in the future,” Newton said. “But we don’t really know what the antibodies mean” at this point, and even the good antibody tests have a “high false positive rate,” Newton said.
Nick Gerda covers county government for Voice of OC. You can contact him at email@example.com.
Noah Biesiada is a Voice of OC Reporting Fellow. Contact him at firstname.lastname@example.org or on Twitter @NBiesiada.