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Coronavirus antibody testing is a 'wild west' in NY 

click to enlarge A patient has blood drawn for a coronavirus antibody test.

FILE PHOTO

A patient has blood drawn for a coronavirus antibody test.

Both hospital systems in the Rochester area say they now have more supply than demand for their coronavirus lab tests. Gov. Andrew Cuomo said supply was outpacing demand across New York state, and last week the state Health Department expanded its guidance for who should be tested.

Andy Ophardt, who manages a primary care clinic in Brighton, said he used to field frequent questions from patients asking about how to get tested for the virus. He had to call testing sites to confirm that people his office referred met an exacting set of criteria.

Now, he said, “that all seems to have loosened up quite a bit. We might give them just a courtesy call and say ‘Hey, we’ve got this patient coming over.’ ”

The new frequently asked questions, Ophardt said, are about antibody testing. Also known as serology testing, the aim of the tests is to determine whether a person has already had the coronavirus and fought it off.

But Ophardt said his office was having trouble advising people about the antibody testing. “It’s kind of the Wild West. There’s no guidance, no direction on it,” he said.

A dozen antibody tests are authorized for emergency use by the federal Food and Drug Administration, but no test is approved by the agency for use on a permanent basis outside of the current emergency.

Neither the New York state Health Department nor the Monroe County Public Health Department has offered specific guidance about who should get antibody tests. Both health departments, however, cautioned against putting much faith in the results of the tests.

New York state’s Wadsworth laboratory offers one of the tests authorized under the FDA’s emergency use rules. A positive test likely indicates some form of immunity to the virus, the state said, but it’s not clear how much or how long it might last.

And the Wadsworth test, like others, is subject to false positives and false negatives that researchers say makes interpreting their results difficult.

'IT'S KIND OF THE WILD WEST'

Antibody tests are now available at privately run urgent care clinics and diagnostic centers across the state, including in Monroe County, where Public Health Commissioner Dr. Michael Mendoza said he’s aware of the testing but “does not want to express any confidence in it.”

“We still do not have a lot of information or insight into the reliability of the antibody tests that are available,” Mendoza said through a spokesperson.

Without state or local guidance, some doctors offices in upstate New York said they were not even aware that antibody tests were available. Many of those who did know about the tests said they learned about them by fielding questions from patients.

On a conference call between office managers at private practices in Monroe County on Thursday, the participants mused about what direction they should give patients who ask about antibody tests.

“We ended up basically saying, well, let’s heap on the caveats,” Ophardt said. “If you really are set on getting the test, there’s nothing that prohibits you, but keep in mind, A, it may not be accurate, and B, even if it is accurate, we don’t know what it means.”

Emil Lesho, the hospital epidemiologist at Rochester Regional Health, said he was concerned that without that counseling, positive antibody test results would lead people to abandon the public health strategies that have prevented hospitals in upstate New York from being overwhelmed with COVID-19 patients.

“We worry people will have a false sense of security when the test is positive. They’ll think, ‘Okay, I’m immune,’ or, ‘I’ve had it. Now I don’t have to do my social distancing, or I don’t have to do my masking,’ ”

Lesho said. Lesho and other doctors around the state said the tests could have some utility for disease surveillance if results were gathered in a controlled way. On a population level, they said, the test’s reliability matters less than it does for individual patients.

“You can control or adjust for that rate in a population,” Lesho said. “Individually, you can’t just say, ‘Well, there’s an 80% chance that you have the antibodies.’ What’s a patient going to do with that?”

At the group of independent doctors’ offices affiliated with Rochester Regional Health, chief medical officer Dr. Jeffrey Allen said he was encouraging physicians not to recommend antibody testing.

“At this point, we really shouldn’t be using serology testing in a way that affects patients’ behavior,” he said. “There’s nothing this test tells us about whether we can safely go to work or gather in groups or anything of that sort.”

The companies that offer the tests said their results were reliable and could provide useful data for researchers studying COVID-19, but verifying their claims is difficult.

“Our tests are highly accurate, returning results with 95% sensitivity & 96% specificity,” a spokesperson for WellNow Urgent care, which administers tests in the Rochester area and across upstate New York, said in an email.

Sensitivity is a test’s ability to correctly identify positive results, and specificity is its ability to rule out negatives.

WellNow sends its antibody test specimens to a company called Boston Health. A spokesperson for Boston Health affirmed WellNow’s information about the test’s sensitivity but declined to answer specific questions about the test itself.

“We don't release the platform name of our antibody test for competitive reasons,” the spokesperson said.

The FDA’s estimates of antibody tests’ sensitivities range from 77% to 100%. “That’s part of why it’s really difficult to assess the reliability,” Lesho said.

Quest Diagnostics offers antibody tests at several sites in New York state, mostly in Erie County. In a news release announcing the availability of those tests, the company acknowledged potential problems with false positives and interpretation of the tests.

“Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains,” the company said, using the scientific name for the virus that causes COVID-19. “At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity.”

The tests cost upwards of $100 if they’re not covered by insurance.

Leslie Moran, a spokesperson for the New York Health Plan Association, said there was no industry-wide agreement on coverage of antibody testing. That decision was up to each company, Moran said. "I do not know how individual plans are handling testing being done specifically to detect antibodies."

Excellus BlueCross BlueShield, the largest health insurance provider in Monroe County, said it would cover antibody testing if a doctor determined it to be medically appropriate for diagnosis and treatment, the test was FDA-approved or -authorized, and the lab performing the testing was appropriately certified.

MVP Health Care, the second-biggest insurer in the region, said it was still evaluating whether to offer coverage for antibody testing.

Two health system administrators in upstate New York who asked not to be named because they were not authorized to speak to the media, said in separate conversations that selling antibody tests to consumers looked like “a money grab.”

“These tests have a purpose,” one administrator said, “but testing individual people and telling them the results when we don’t really know what the results mean? That’s not where we should be right now. That can get very, very dangerous.”

Brett Dahlberg is a health reporter for WXXI News, a media partner of CITY. He can be reached at bdahlberg@wxxi.org.
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