A Lenexa lab is marketing coronavirus antibody tests that are not federally approved as a way for nursing homes to figure out which workers don’t pose a threat to residents.
State health officials and medical experts say the claims that the tests would provide facilities peace of mind are “wrong” and “risky.” The president of Great Plains Laboratory Inc., William Shaw, canceled an interview with the Kansas News Service. In an email, he said he had not reviewed the sales pitch before it went out.
It remains unclear whether COVID-19 antibodies prevent people from contracting the virus a second time. Scientists are hopeful, but don’t yet know how long immunity might last and how many antibodies must be present in order to be protected.
That’s why the Kansas Department of Health and Environment says misinterpreting or misrepresenting the value of unproven COVID-19 tests could fuel the virus’ spread if nursing staff mistakenly think they’re immune and become lax about protective gear.
Older people are among the most vulnerable if exposed to COVID-19, with outbreaks in long-term care facilities killing at least 95 people in Kansas — more than half of the state’s death toll.
“Without knowing how the presence of antibodies translates to immunity to COVID-19,” state epidemiologist Farah Ahmed said in an email, “you could potentially be putting staff and residents/patients at risk.”
Bethany Home Association, a nursing home in Lindsborg, received the pitch from Great Plains Laboratory by email. The lab encouraged pre-ordering tests at $99 each and billing Medicare or private insurance for it.
Kris Erickson is the nursing home’s CEO. He chose not to buy them.
“On the surface, the testing offer was very tempting,” Erickson said. But he couldn’t risk buying something that wouldn’t actually protect his residents. So he ran it past his wife, Farah Erickson, a consultant at WPM Pathology Laboratory who advises nearly 30 hospital and clinic labs across central Kansas on quality control and more.
The email raised immediate alarms for her: “My brakes were squealing hard,” she said. “I was like, ‘Oh no, no, no.’”
The email said that staff with the right kind of antibodies “will no longer represent a threat of infection to other staff members and/or residents. The same applies to all residents. Those residents who develop (Immunoglobulin G) antibodies to this virus can gather together in the same spaces of the home without representing a risk.”
Not so, said Amesh Adalja, an infectious disease expert at Johns Hopkins University. Some antibody tests give false results, wrongly signaling a patient has COVID-19 antibodies.
“It is premature to be able to say that ‘This staff member is impervious to infection,’” he said.
Serology expert Jim Zehnder is a professor at Stanford University, which has developed its own COVID-19 antibody test.
“I understand the desire to make chronic care facilities safer,” he said, “but using the antibody status to do this is unproven.”
Shaw, the CEO of the Lenexa lab, said in his email to the Kansas News Service that “brochures and website material that are already prepared do not contain any of the controversial statements in the (marketing) email.”
Antibody, or serology, tests differ from the nose swab tests that doctors use to diagnose an active coronavirus infection by searching for viral genetic material.
Scores of antibody tests have appeared on the market, most with no federal approval or emergency authorization. That leaves buyers at the mercy of manufacturers’ claims about test accuracy. A low-quality test can mistake a common cold for COVID-19.
Farah Erickson is familiar with the long lines and persistent shortages that labs are facing as they try to buy proven materials for COVID-19 testing. By contrast, the email her husband received promised an easy answer with “capacity to test large scale populations.”
“If what the nursing homes are getting offered is abundant and available, I guarantee you that no hospital is going to do it right now,” she said. “All of the good stuff is still in queue.”
Last month, the Kansas State Department of Health cautioned health care providers about antibody tests after a hospital in central Kansas advertised non-FDA-approved tests as a way for locals to know whether they are safe from COVID-19.
“That can lead a person down a dangerous path,” health secretary Lee Norman said at the time. “Which is, ‘I believe that I’m immune to COVID-19,’ when in reality the patient, the person, maybe has never been exposed to it. Never had it at all.”
Celia Llopis-Jepsen reports on consumer health and education for the Kansas News Service. You can follow her on Twitter @celia_LJ or email her at celia (at) kcur (dot) org. The Kansas News Service is a collaboration of KCUR, Kansas Public Radio, KMUW and High Plains Public Radio focused on health, the social determinants of health and their connection to public policy. Kansas News Service stories and photos may be republished by news media at no cost with proper attribution and a link to ksnewsservice.org.