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Trump presents "five minute" covid-19 test
(CNN) - The Bodysphere company said it would distribute the first test for antibodies against coronavirus authorized by the United States Food and Drug Administration (FDA). It promised to detect current and past infections in as little as two minutes, with just a small amount of blood.
"This is a game changer," the company, Bodysphere, said in a statement Tuesday. He promised to deliver millions of test kits in weeks.
Multiple media outlets reported on the announcement. The company's website, with the words "MADE IN USA" underneath a sleek logo, featured photos of the test, including the FDA logo on its box.
And in a tweet on Monday, Bodysphere wrote: "It is not the first time that we will play an important role in changing the world."
But the company's claims of an FDA-approved coronavirus antibody test have been explicitly rejected by the FDA.
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Bodysphere said Tuesday that the serology test had received what is known as the FDA Emergency Use Authorization. Serology is another word for studying blood, and the company said the test could detect antibodies with a process as simple as a glucose test.
But Michael Felberbaum, an FDA spokesman, told CNN later that day: "No serology tests have received an authorization to detect coronaviruses."
D'Anne Mica, a spokesperson for Bodysphere, told CNN throughout Tuesday that the company had received clearance for the test, despite the FDA statement.
But on Wednesday, Mica reported that "there was a misunderstanding" and acknowledged that the FDA never issued the emergency authorization.
In a statement that night, the company's chief executive, Charlton Lui, said his company "mistakenly believed" that it had received authorization "in a hurry" to deliver evidence, blaming a misunderstanding of paperwork.
Also on Wednesday, two of the news organizations reporting on Bodysphere, Reuters and Axios, withdrew their articles.
READ: Questions and answers about tests and kits to detect coronavirus
The damage appears to have been done: After the company's false claims, people rushed to buy the evidence. "The phone line was blocked," Mica said when asked how many orders the company had received.
Mica said that "people desperate to get these test kits" had been calling her, despite the fact that she is a media representative. "They have been driving me crazy."
He said he had received messages from people asking for tests: “North Carolina mothers who just wanted to test their children because they had all the symptoms. Someone called me from Tampa. "
A foreign embassy had even called four times, he added.
A different antibody test has now been authorized
"HUMANITY GOES HIGH-TECH," says Bodysphere on its website, which also includes N95 masks, disinfectant gel, and hospital beds.
The site, which features photos of lions and an astronaut, indicates that Bodysphere has "Alchemy Laboratories" and is involved in creating "Hemp Bio Plastics."
However, the company's most prominent product is its rapid serology test.
Such tests can look for antibodies to the coronavirus, a sign of recent or past infection, even if someone never showed serious symptoms.
READ: The FDA authorizes a new test that could detect the coronavirus in approximately 45 minutes
The FDA cautioned that serology tests "should not be used as the sole basis for diagnosing or excluding [coronavirus] infection or for reporting the status of infection."
But in an emergency use authorization dated Wednesday, the FDA gave the go-ahead for an antibody test from a different manufacturer, Cellex Inc.
The FDA told the company that "it is reasonable to believe that its product can be effective in diagnosing covid-19," adding that the benefits of the test outweighed its risks. The Cellex test, then, became the first FDA-approved antibody test.
Beyond diagnosing the virus, serological tests can be helpful for research, such as determining what percentage of the population has been infected, according to the US Centers for Disease Control and Prevention.
That would allow researchers to understand how widespread coronavirus infections really are, including mild or asymptomatic cases. But only the Cellex antibody test has been explicitly cleared by the FDA as of Thursday.
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On Wednesday, the FDA logo had disappeared from the test photos on the Bodysphere website. However, a downloadable company catalog still featured the FDA logo on the test.
A variety of other products in the catalog, including hospital beds and face shields, also featured the FDA logo.
"The FDA logo is for official use by the United States Food and Drug Administration (FDA) and not for use on private sector materials," says the FDA on its website.
“To the public, such use would send a message that the FDA favors or endorses a private sector organization or the organization's activities, products, services, and / or personnel (whether openly or implicitly), which FDA does not and cannot do. "
FDA clearance would have given confidence in the test
The FDA, according to regulations issued last month, allows companies to conduct and distribute serology tests that have not received authorization.
But according to Felberbaum, the FDA spokesman, those companies should include something like: "This test has not been reviewed by the FDA."
That's important, because antibodies, which are looked for by serology tests, are our body's response to an infection and can take time to develop. That means that these blood tests may not be able to identify recent infections.
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Most coronavirus tests, by contrast, generally require a swab to be used on the patient. Then the test looks for the genetic information of the virus and should be able to detect every time someone is removing the virus.
Bodysphere said in its press release that the blood test "has not been approved or approved by the FDA," but the company falsely claimed that the test "had been authorized by the FDA under an Emergency Use Authorization for use by licensed labs and patient care settings. ”
Full FDA approval is an extensive process that no coronavirus test has yet accomplished. But an agency Emergency Use Authorization would have been a sign that regulators believed the benefits of using a designed blood test quickly outweighed the risks, such as the possibility of false positives or negatives.
In its press release, Bodysphere stated that the two-minute coronavirus serology test had a specificity of 91%, meaning that 9% of people could give false-positive results for the virus without being infected.
It is not made in the US, despite the company's claims
Mica, the Bodysphere spokeswoman, told CNN on Tuesday that it would take time to send the documentation for the test because the company conducting the tests was based in China. "[Bodysphere] is the authorized distributor, the US distributor," Mica noted.
"The kits come from China, so they don't come from China, but the company is, everything, you know, it's made in China right now," he added.
In a call Wednesday, after acknowledging that the FDA had not issued an emergency authorization for the Bodysphere test, Mica confirmed that the test is not designed or manufactured in any way in the United States.
However, the company's website still suggests that its products are American-made. Underneath the company logo, for example, are the words "MADE IN USA." And a page in the company's catalog highlights "Proudly American" in italics.
While Mica said Bodysphere had already received numerous requests for its test, the company publicly admitted Wednesday that it had not received the authorization it had originally claimed.
In a Twitter response to a skeptical observer, the company said: "You appear to be in combat to demonstrate that our company is not trustworthy."
"We also apply for the FDA," added the company, but "the process takes time. And the virus doesn't wait. "
CNN's Michael Nedelman contributed to this report.
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