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Attorney General Gurbir S. Grewal said his office and the state Division of Consumer Affairs sent cease-and-desist letters telling each to stop claiming that they have antibody (“serological”) COVID-19 tests that can tell whether someone is immune from COVID-19.
“Misinformation of this nature has the potential to provide false security to individuals and contribute, in the aggregate, to widespread public harm, and also violates New Jersey’s Consumer Fraud Act,” the letters say.
Antibody testing is intended to determine if you possess antibodies to the SARS-CoV-2 virus that causes COVID-19, which indicates past exposure to the virus. Diagnostic testing is intended to determine if you currently have the disease.
The U.S. Food and Drug Administration has said that antibody tests shouldn’t be used “in the immediate diagnosis of a patient where COVID-19 infection is suspected.”
That’s because a serology test can yield a negative test result even in infected patients or a false positive in those who aren’t, the FDA said.
Serology tests may someday be used, together with clinical data, to determine whether people with the antibodies may be less susceptible to infection, the federal agency said.
Currently, however, “it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity,” it says.
In the letter to the Passaic County dentist, the Division said it had received information that he’d made misrepresentations in advertising serological tests for sale to other dental and medical practitioners.
The advertising reportedly said, among other things, that medical practitioners can determine that a patient, upon testing positive for a particular antibody, is “now clear, they have the antibody, they're safe.”
As the FDA said, it hasn’t been established whether the presence of COVID-19 antibodies conveys immunity – or for how long, Grewal noted.
It also hasn’t been established whether or not someone with antibodies will be able to spread the virus, he said.
In the letter to the Morris County health club, the Division said it received information that it “made misrepresentations in advertising COVID-19 antibody testing available to club members via a health and wellness center affiliated with the club.”
Among other things, the letter noted that the health club’s advertising said that serological tests can determine “if someone has already contracted the virus and, thus, has developed the antibodies to prevent contracting it again.”
The statement appears misleading, Grewal said.
For one thing, a person may have contracted the virus but not yet developed antibodies that would result in a positive antibody test, the attorney general said.
It also hasn’t been established, as mentioned in the dentist’s case, whether the presence of COVID-19 antibodies means you’re immune or for how long, he said.
Grewal said he wasn’t identifying either the dentist or the health club because of continuing investigations.
“We’re urging consumers to do their homework, understand the types of tests being marketed, and recognize what those tests can and cannot do," the attorney general said.This way, he said, they won't "fall victim to false promises and outright scams.”
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