FDA Boosts Scrutiny of Virus Antibody Tests as Fakes Flood Market

May 5, 2020 Updated: May 5, 2020

The Food and Drug Administration (FDA) has imposed more stringent oversight of CCP virus antibody tests after previously allowing hundreds of tests to hit the market without adequate evidence that they meet quality and accuracy standards.

Under the updated guidelines, companies that sell the tests are now required to send the FDA an application for “emergency-use authorization” (EUA), along with data showing the tests’ accuracy within 10 business days, the agency said in a statement. Tests will need to be found 90 percent “sensitive,” or able to detect CCP virus antibodies, and 95 percent “specific,” or able to avoid false-positive results.

Previously, the FDA faced criticism for only requiring companies selling virus antibody tests to attest their product is valid and label them as unapproved, attracting 170 companies to the antibody test market, including unscrupulous vendors making false claims, Reuters reported last week. At the time the policy was issued on March 16, the FDA had been under pressure to move quickly following a slow ramp-up of COVID-19 diagnostic tests that hindered public health efforts.

“Flexibility never meant we would allow fraud,” FDA officials Anand Shah and Jeff Shuren wrote in a statement this week. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.

“Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

The headquarters of the FDA
The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Md., on Nov. 4, 2009. (Jason Reed/AP-File)

The FDA said that to date, 12 antibody tests have been authorized under an individual EUA, most within just the past few days, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review.

Serology tests, or blood tests for antibodies, are used to determine who has been previously been infected with the virus. Since the CCP (Chinese Communist Party) virus, commonly known as the novel coronavirus, can be easily spread by people with no symptoms, widespread antibody testing is seen as a critical piece toward getting Americans back to work safely, as the presence of antibodies to the virus may indicate possible immunity to future infection.

The FDA said it’s taken action against firms for unlawfully marketing tests by detaining and refusing illegitimate test kits at the border and will publicly share information regarding those commercial manufacturers that are currently marketing tests under its March 16 policy who fail to submit an EUA within 10 business days.

“We will keep up our work to stop illicit tests from entering the U.S., and we encourage states, hospitals, and consumers to be on high alert and to make informed purchasing decisions regarding these tests,” the agency stated.

While antibody tests have been rolled out across the United States, researchers have questioned their accuracy and reliability, as some have provided high rates of false positives. The World Health Organization also cautioned in April that there’s no proof yet that a patient who has recovered is immune from becoming reinfected.

In its statement this week, the FDA said the public needs to understand the limitations of antibody tests and noted that all tests can provide “at least some false results,” even those deemed “high-performing.”

“That is why antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts,” it stated.

Reuters contributed to this report.