With pressure mounting to get Americans back to work, the new focus is on tests that purport to indicate antibodies to the SARS-CoV-2.
These serological tests are supposed measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. Many companies in China have been marketing such tests, but U.S. and global public health officials warn that inaccuracy is a big problem, according to a report in the New York Times. Even when the tests are accurate, no one knows how long such immunity in people who have already had the virus will last.
In March, the FDA issued a policy to allow developers of certain serological tests to begin to market their tests once they have evaluated the tests for accuracy and reliability. This includes allowing developers to market their tests without prior FDA review if certain conditions outlined in the guidance document are met.
Since then, more than 90 companies have released such tests, the Times article noted. The FDA has received applications for emergency-use authorizations (EUAs) from 120 companies developing antibody tests, and has granted four. Those are made by Cellex, Ortho Clinical Diagnostics, Chembio Diagnostic Systems and Mount Sinai Laboratory.
The companies making most of the available serological tests are marketing them as safe to conduct at a doctor’s office and as able to provide results quickly. The World Health Organization recently recommended against their use because these rapid-result tests are the most unreliable.
The FDA did not immediately respond to questions about oversight and accuracy of serological tests for COVID-19, but FDA commissioner Stephen Hahn said in a statement on Saturday that the agency is “working around-the-clock to review EUA submissions quickly and we continue to take steps to ensure the process is as streamlined and efficient as possible.”
The agency is working with the National Institutes of Health’s National Cancer Institute and National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention (CDC) to enable NIH to evaluate serological tests for developers — those already in use and those not on the market, according to Hahn.
“Performance assessments for serological tests will begin soon, and we expect to start seeing results shortly thereafter,” he said. “We will review NIH’s results expeditiously, and performance results from NIH’s assessment may complement and inform the determination of whether FDA issues an EUA for a particular test…
“Every step we have taken as part of our approach to COVID-19 testing has been a careful balancing of risks and benefits in order to meet the urgent public health needs as we combat this new pathogen,” Hahn said. “We have moved quickly and thoughtfully, and we are continuing to learn and adapt based on the real-world experience and data we’re seeing.”