Thousands in Miami-Dade have gotten these antibody tests. They may not be accurate.
Over the past month, thousands of Miami-Dade County residents have poured into drive-thru testing sites in Aventura and Bal Harbour seeking the answer to one question: Do I have antibodies for COVID-19?
They were trying to get answers from a Nebraska healthcare company with connections to the Aventura mayor.
Armed with city officials’ endorsements, Banyan Medical Systems from Omaha opened a testing site for coronavirus antibodies in a parking garage at Aventura Mall on April 13, then did the same at Bal Harbour Shops on May 4. Banyan has plans for two more, in Doral and Cutler Bay.
But the test Banyan uses to determine whether a person has had the coronavirus has not been validated by federal regulators — like dozens of others that flooded the market after the Food and Drug Administration relaxed rules normally governing medical tests. The test’s accuracy has come under fire by scientists in a California study, and drawn scrutiny from a congressional subcommittee, which told a U.S. distributor of the test that the study results were “deeply troubling” because it found that the test accurately detects antibodies much less often than reported by the manufacturer.
Michel Koopman, vice president of Banyan Medical and a resident of Aventura, said that while the tests are not always accurate, he stands by his operation.
“It’s not a get-rich-quick scheme,” Koopman said. “It’s true care, and we’re really trying to deliver value.”
Antibody tests like the one provided by Banyan are quick and easy to use. They draw blood through a finger prick instead of inserting long swabs into the nose and throat to obtain samples, and they do not require special lab equipment to process. Banyan uses a test that is manufactured in China and sold in the United States under five different brand names. The results are easy to read, similar to a pregnancy test.
The test became available to U.S. consumers in March when FDA officials offered “regulatory flexibility” for developers to increase testing capacity, and because the tests are not intended to diagnose active COVID-19 infections, just past exposure. The agency changed course May 4 and now requires all manufacturers to submit the results of a clinical study and to apply for emergency use authorization, or EUA.
To win the emergency designation, the FDA wants tests to score at least 90% accuracy in finding a single type of antibody — indicating previous exposure to the virus — and at least 95% accuracy when samples don’t contain that antibody, according to an application template the agency posted online for manufacturers. The FDA has reviewed and authorized 13 serology tests for emergency use to date. Banyan’s test is not among them.
On the websites for Banyan’s Aventura and Bal Harbour operations, the “frequently asked questions” section initially stated that the tests — Banyan uses one branded CoronaChek — were “EUA approved by the FDA.” This week, Banyan edited the language to say the tests are “EUA allowed by the FDA.” The website also notes that the test “has not been reviewed by the FDA.”
Koopman said he was under the impression that, “There’s not one antibody test that is FDA approved. They’re all allowed.”
The lack of oversight on antibody testing has created a confusing situation for consumers eager to find out if they have any level of immunity amid a worldwide pandemic. Health experts have cautioned that it’s unclear whether past exposure actually means you can’t get the coronavirus again, even for a period of months.
In Banyan’s case, the company has already tested thousands of people and billed their insurance companies, despite the test’s not fully proven results.
Banyan entered the market — as the first Florida drive-up antibody testing site — through a personal connection between Koopman and the Aventura mayor, Enid Weisman. Weisman, who said she was acquainted with Koopman’s wife through the wife’s involvement in a local charter school, then spread the word to other local mayors.
“There’s no skin in the game for the city,” Weisman said. “It was done with all good intentions to provide something that would be close [for residents] and afford a rapid kind of test.”
In setting up the sites, Banyan partnered with two related companies — a marketing firm and a startup “concierge” health clinic in Omaha. Combined, the two Miami-Dade locations are processing about 1,000 tests a day, Koopman said.
How accurate are tests?
Banyan’s website for the Aventura site says that the tests are “more than 90 percent accurate,” which reflects what the distributor reports in the test’s package insert.
But an independent study in California found that the test accurately detects the antibodies much less often than reported by the manufacturer — drawing the attention of a congressional investigation into serology testing for the novel coronavirus.
CoronaChek is the brand name of the antibody test sold by a San Diego distributor named CLIAwaived, Inc. and made in China by Hangzhou Biotest Biotech. The same test is sold under five different names by other U.S. distributors, including a company named Premier Biotech in Minneapolis.
In an April 28 letter to Todd Bailey, the CEO of Premier Biotech, the chairman of the House subcommittee on economic and consumer policy, which is investigating serology testing claims, took note of the findings by the University of California San Francisco, University of California Berkeley and Massachusetts General Hospital.
“The discrepancies in these performance characteristics are deeply troubling,” said Rep. Raja Krishnamoorthi, in the letter to Bailey.
Researchers from the California study, who reviewed the test from Premier Biotech, found a much higher risk of false negatives than reported by the test’s manufacturer. The company’s literature says the test finds long-term antibodies called IgG — those that show a person had COVID-19 weeks or months ago — 100% of the time. And it claims the test accurately detects short-term antibodies from more recent infections, called IgM, 91.8% of the time.
The California study, which has not been peer reviewed by independent researchers, found much lower sensitivities, of 53.5% and 68.5%, the congressional subcommittee said. That means there could be a fairly high risk that the CoronaChek test will come up negative for a person who has actually been infected.
Alexander Marson, an immunologist with UCSF and co-author of the California study, said the data are preliminary and still subject to review. But the research team intends to submit the evaluation for peer review.
Public health experts agree that testing for both active and past infections is key to lifting social distancing orders and reopening businesses, though it’s still uncertain how much protection a past infection offers.
Michael Carome, a physician and director of health research for Public Citizen, a consumer advocacy group, said inaccurate testing could create a false sense of comfort for consumers. But with so many tests already on the market, Carome said, “the horse is out of the barn.”
“You have a lot of people who’ve been tested and given results. ... So some people are already acting on perhaps incorrect information and we don’t know who those people are,” Carome said.
Bailey, the CEO of U.S. distributor Premier Biotech, said in a prepared statement that the Hangzhou Biotest Biotech test has been independently evaluated by researchers at Stanford University and other institutions and found “strong product performance.”
Bryan Andrus, chief operating officer for the San Diego distributor, also said the company stands behind the CoronaChek’s accuracy.
Omaha to South Florida
The cities that have given Banyan permission to set up test sites say there is no financial partnership — but the websites for the Aventura and Bal Harbour testing sites list each city as a “sponsor” and feature a testimonial from the local mayor.
Because of the ongoing state of emergency, the arrangement also didn’t need to be vetted or approved by Aventura’s city commission. Once Aventura’s site opened April 13, Bal Harbour Village followed, after Weisman mentioned Banyan on a conference call with other mayors of the county’s coastal cities.
The village agreed to expedite Banyan’s permits for a testing site in the parking lot of Bal Harbour Shops. Three other nearby municipalities — Bay Harbor Islands, Surfside and Indian Creek — were also listed as sponsors on the website and promoted the tests to their residents.
“After their successful launch of a testing facility at the Aventura Mall, we were happy to hear from Banyan in late April that they were interested in opening a site at the Bal Harbour Shops,” Bal Harbour Mayor Gabriel Groisman said. “The testing facility ... is privately run and has been widely praised by our residents.”
Two more cities are interested. Cutler Bay officials said they met with Banyan representatives Tuesday to discuss a potential testing site, and in Doral, a spokeswoman said the city was hashing out details to set up a site.
Though many are anxious to get tested for antibodies, perhaps to confirm long-held suspicions they had already been infected, it’s unclear whether the tests like those being used by Banyan Medical are reliable enough to depend on.
Marson, the UCSF immunologist, said it’s still too early for doctors to interpret serology test results without additional research on immunity.
“It may be premature to be offering these tests,” he said. “I worry it might be sending an implicit signal that’s not responsible to people that they’re somehow protected if they have the antibody. We really need more studies before giving that sense to people.”
Natalie Dean, a biostatistician and professor at the University of Florida’s college of public health, said in an email that antibody tests that are more likely to produce false negatives — as may be the case with CoronaChek — are less of a concern than those that give consumers a false sense of security that they’re immune to COVID-19.
“In the context of antibody testing, the biggest risk is in a false positive. People thinking they are immune when really they have no antibodies, engaging in riskier behavior,” she said.
Koopman said Banyan tells consumers that the test results are not perfect.
“We can give them some explanation of what IgG or IgM means, what it means to have one or none or both of them, and then of course explain to them that the scientists, not us, don’t really know what that means,” he said. “It’s likely you’ll have some resistance but for how long? And how many strains are out there? I don’t know. It would be very dangerous to give people a definitive answer. But it does give them some idea. It’s the best we can do.”
To get tested, consumers make an appointment by filling out an online form that includes insurance information. The website says that those who have no insurance coverage can be tested and suggests a $99 donation.
At the Bal Harbour site, consumers enter through a guard gate and drive up to a big screen TV under a white tent, where they roll down their window and speak with a nurse or doctor in Nebraska who asks about symptoms, travel history and other information. Then there’s a telehealth consultation with a physician from Pivot Concierge Health, a membership-based “holistic” clinic that offers primary care and wellness treatments such as hyperbaric oxygen chambers, infrared saunas and other services.
Once the virtual visit ends, consumers drive up to a second station where a worker in gloves and mask draws a finger prick of blood for the test. Results are delivered by phone as soon as later that day.
Koopman said he has not heard back from insurers about whether they will cover all of the services provided. He said persons tested at the site will not be billed if their health insurer denies the claim.
“I hope that we get paid because the truth is there are some new regulations,” he said. “We are investing a hell of a lot of money here to help out our communities.”
This story has been updated to clarify the nature of Weisman’s relationship with Koopman’s wife.
This story was originally published May 16, 2020 at 7:00 AM.
