Faced with Confusion, Questionable Claims, FDA Addresses Coronavirus Serology Testing

The FDA now has two pathways for serological tests, as previously reported. The so-called “Policy D” is meant for blood tests that detect a patient’s antibody response to the virus, which can indicate a current or previous infection. Under this policy, tests are allowed to be marketed in the US as soon as the manufacturer sends an email notifying FDA that it has completed a validation.  

A pathway called “Policy C” is also open to serology tests. In this pathway, a manufacturer files an Emergency Use Authorization application, which potentially involves a more rigorous validation process. The agency said previously that this pathway could be for tests that are meant to be used at the point of care or for sole diagnosis of COVID-19.

Since the FDA began allowing serology-based SARS-CoV-2 tests to be marketed under policies C and D, some firms have launched their products with dubious claims about their regulatory status, which has caught the FDA’s attention. The agency is trying to make it clear that firms that have gone through Policy D are not EUA authorized, and on Tuesday FDA Commissioner Steven Hahn issued a statement stating, “Some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.”

Tests that receive EUA have been authorized for use in specific environments. For example, the Cellex serology test is for use in labs authorized under CLIA regulations to perform moderately complex testing. Tests that are authorized in their EUA for point-of-care are deemed to be CLIA-waived tests.

But, tests that have gone through Policy D have not been reviewed by FDA and have not received a CLIA categorization, and so they revert to highly-complex test status, Stenzel noted.

“It was not our intention to limit the use of rapid serology tests that are otherwise designed to be used in a point-of-care setting. However because of the limits that we have in law, it is the opinion of [the Centers for Medicare and Medicaid Services] that these can be performed in high-complexity labs,” Stenzel said. He added that developers can choose to come through a full EUA authorization process so that a test can be deemed point-of-care and be allowed to be used in waived settings.

Source: https://www.360dx.com/immunoassays/faced-confusion-questionable-claims-fda-addresses-coronavirus-serology-testing