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Some manufacturers are inappropriately marketing their COVID-19 antibody/serology tests for diagnostic use, US Food and Drug Administration officials said at a 4 May press briefing. The realization has prompted the agency to revise its immediately-in-effect guidance of 16 March for both diagnostic and antibody tests. 

While high-quality antibody tests can provide information about a population’s exposure to COVID-19, “the antibody tests may not be used as the sole basis for diagnosing cases of coronavirus,” FDA commissioner Stephen Hahn told reporters.

“Yes, we need the data [from antibody tests] to better understand certain aspects of the disease. But is taking the test and learning you have antibodies the ticket to going back to work? No,” Hahn said.

Both Hahn and FDA device center director Jeff Shuren pointed to an updated guidance issued on 4 May on the subject of submitting data to the agency to win an emergency use approval (EUA) for either a diagnostic test or serology (antibody) test, that is meant to supersede an earlier immediately-in-effect guidance issued on 16 March.  (Also see "Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process" - Medtech Insight, 17 Mar, 2020.)

The latest guidance provides directions on both diagnostic and serology test validation, FDA notification and EUA requests, as well extensive details on measuring molecular diagnostic limits of detection, clinical evaluation, inclusivity and cross-reactivity.

The 4 May guidance is more than twice as long as the 16 March version, and warns that “FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, or are performing badly based on an independent evaluation” by the National Institutes of Health.

The document adds that these abuses “indicate that greater FDA oversight of commercial serology tests is important to protect the public health.”

“We are concerned about these antibody tests. …There are still unanswered questions about what it means to be antibody-positive or antibody-negative.” – Stephen Hahn

At the news briefing, Hahn further explained that serology testing is only a way of distinguishing if a person has been exposed to the virus and developed some antibodies to it. But he added that there are still “a lot of unanswered questions” about exactly what serology testing can show in coronavirus cases.

He also noted that the agency has taken action against firms that are unlawfully marketing their tests as proof of immunity from the coronavirus.

“We are concerned about these antibody tests,” Hahn said. “There are still unanswered questions about what it means to be antibody-positive or antibody-negative.”


Serology Tests Not Usually For Home Use, Shuren Says

“We have identified developers of [antibody] tests who are inappropriately marketing these, some for use at home, when most are not authorized for that,” Shuren said at the briefing in response to a question from Medtech Insight. “Some have claimed they have been authorized by the agency, when they have not, or they are making other claims.”

In FDA’s follow-up to these misuses of serology tests, “in some cases we remove them from the market,” Shuren said, and in other situations, the manufacturers are referred to the agency’s criminal enforcement division.

Hahn also reminded reporters: “If a test developer hasn’t submitted an EUA application, we will take actions against them.”

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