In late March, the California company RootMD started advertising "at-home Covid-19 exposure and immunity tests" for consumers worried about the coronavirus. For $249, the company said it would mail out a test kit — including a "lancet" that buyers could use to prick their finger and collect a blood sample. Then, the company promised, consumers could mail that sample back to "certified MD immunologists" to test for antibodies to the coronavirus, and get results within 48 hours.
At the time, the Food and Drug Administration had not authorized any at-home tests for COVID-19. But the company's marketing materials appeared to suggest the FDA had vetted the RootMD kits. On Instagram and Twitter, the company's messages included the hashtags "#FDA #Approved."
On its website, the company's messaging was different. The site stated that "the test has not yet completed the several month investigation periods by the FDA to be labeled as approved." Still, the company claimed, the FDA had issued guidance "allowing its use under emergency provisions."
In fact, the FDA has made clear that any tests sold under its emergency guidance are only for use in health care settings, and that the policy "does not apply to at home testing" — including home collection of test samples.
The RootMD test soon caught the attention of the city attorney of Los Angeles, who in a lawsuit filed this week alleged that the company violated food and drug regulations, as well as laws against false advertising. As part of a settlement reached on Thursday, the company agreed to pay a $5,000 penalty, refund all customers and cease all sales of COVID-19 tests unless it receives authorization from the FDA.
In an interview before the lawsuit was filed, RootMD's co-founder, Dr. Elroy Vojdani, said he had sold around 800 kits. He expressed regret about statements made by the company on social media, but he maintained that RootMD had complied with FDA guidelines. Vojdani said he had already ceased sales of the test kits due to concerns about their accuracy, and said the company was offering refunds to customers.
In response to the lawsuit, RootMD issued a statement saying, "All of our blood collection and laboratory testing materials used were of the highest standard." The company also said it "follows all governing regulations."
An attorney for RootMD did not respond to a request for comment on the settlement. The LA city attorney's office declined to comment for this story.
RootMD launched in 2020 with an emphasis on treatments for "chronic gut conditions" such as irritable bowel syndrome, and even offers a "GutCheck" at-home blood test. The company says it can "analyze your blood to find the root cause of disease" and develop a personalized treatment plan that will often include the use of dietary supplements.
Amid the coronavirus pandemic, Vojdani appeared in a Facebook Live video and recommended a variety of supplements to help combat the spread of the virus. Some of those supplements were also available through his medical practice and its online shop.
There has been a surge in supplement sales in response to the coronavirus. But experts have warned that no supplements have been shown to effectively treat the coronavirus, and some may even cause harm if taken in excessive doses.
One of Vojdani's recommendations, colloidal silver spray, has come under intense scrutiny from federal regulators and medical experts at the Mayo Clinic and the National Institutes of Health, among others, who say it is neither safe nor effective for treating any medical conditions. The FDA has also warned several companies against marketing silver products as a treatment or preventive measure for COVID-19, including the conspiracy theorist Alex Jones of InfoWars and the televangelist Jim Bakker.
In his Facebook Live video, Vojdani claimed, "Colloidal silver is very well demonstrated to have antiviral properties and antibacterial properties" and recommended "using colloidal silver spray in the nose as a preventative measure."
NPR asked Vojdani for comment, given the warnings among medical and government authorities that colloidal silver spray is ineffective and potentially unsafe. In a statement, he said his medical practice "stresses the importance of being proactive in our approach to health. That includes being mindful of what one eats, how much one exercises, and what type of energy one puts out into the world."
Limitations of blood tests
With RootMD's expansion into COVID-19 testing, Vojdani joined a growing number of scientists and researchers across the country who have been conducting blood tests that look for antibodies — also known as serology tests — to try to determine how many people have been exposed to the coronavirus.
The FDA has allowed a large number of companies to sell COVID-19 blood tests for use in labs, hospitals and other health care settings. But as the LA city attorney's office notes in its suit against RootMD, the FDA has not authorized any at-home tests for COVID-19, and that includes collecting blood samples at home.
One reason why, according to experts, is that even in lab settings, blood tests can come with certain limitations. For one, it remains unclear whether people with antibodies to the virus are actually immune.
But visitors to the RootMD website got a different message.
If your test results came back positive, the RootMD site claimed, "you will be able to confidently put those around you at ease by helping them know with certainty that they can't contract the coronavirus from you."
Experts say that is untrue.
"There is just no data on whether someone with antibodies against the virus is protected from reinfection," explained Matthew Frieman, a professor at the University of Maryland School of Medicine who researches coronaviruses, in an email.
In response to questions from NPR, Vojdani himself voiced concern about the testing claim made on the RootMD site, agreeing it was problematic. The company has since removed the claim from its site.
"I did not approve that message being put on the website," he said. "I feel really bad that that statement was on the website. I don't agree with it."
Concerns about accuracy
Another issue with at least some of the serology tests for the coronavirus now on the market is that they can be inaccurate, providing an unacceptably high percentage of false positive or negative results.
"There's not a lot of data on how those tests perform," according to Kelly Wroblewski of the Association of Public Health Laboratories.
Vojdani himself said he found problems with the accuracy of his kits. He said he was using test kits from three separate manufacturers. He said he tested samples from the same sources on all the kits, and found "tremendous variation" in the results.
"Obviously, that was a little bit eye-opening and concerning," he said.
On April 7, the Los Angeles city attorney's office says it contacted RootMD, and the company stopped selling test kits the next day.
Vojdani said the halt in test sales was due to his concerns about the tests' accuracy, and not the legal inquiry.
"We don't want to be distributing false information to people." he said. "And these tests are super important and super needed."
The FDA has agreed that serology testing is an important part of the country's response to the coronavirus. But this week, Dr. Stephen Hahn, the FDA commissioner, also issued a warning to companies manufacturing and marketing these tests, saying the agency would "go after" those that make misleading claims.
"It's not OK for someone to say that a test has been authorized or approved by FDA when it hasn't," said Hahn.