Washington, D.C. -Today, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, convened a video briefing to examine the role that serological antibody tests play in the response to the coronavirus pandemic, recommendations and limitations for their use, and federal policy.
“In the midst of a global pandemic, we still have mass confusion about how serology testing can help our country get to the ‘new normal’ as quickly as possible because of how the FDA opened the market to unregulated tests," said Chairman Krishnamoorthi. “I thank today’s briefers for taking time to educate the Subcommittee Members - and the American people - about the current state of serology testing in our country. Because of their knowledge, we are closer to safely reopening our communities and understanding the power of serology testing."
The medical experts briefing the Subcommittee Members shared the following critical information:
The Food and Drug Administration (FDA) antibody testing policy issued on March 16, 2020 was a colossal failure and allowed numerous unregulated, inaccurate and fraudulent tests to be marketed and sold to American consumers.
* Dr. Jesse Goodman, former FDA Chief Scientist, stated that health agencies “stumbled" with early decisions on diagnostic testing, and “chaos" in antibody tests ensued when “both qualified and unqualified entities flooded the market with tests."
* The expert panelists agreed that FDA must quickly review these unregulated tests and recall junk tests. Dr. Goodman suggested that FDA could prioritize review of “high risk" tests. While FDA changed its policy on May 4 to require test-makers to submit to review, there is still work that must be done to address these deficiencies.
Individuals cannot use antibody tests for individual decision-making.
* The four expert panelists were unanimous: Antibody tests have no appropriate use for individuals yet. They should not be used to determine immune status. They should not be used to determine whether to wear a mask or cease social distancing. They should not be used for back-to-work schemes or to manage residential populations. The Centers for Disease Control and Prevention (CDC) issued antibody test guidelines to the same effect, albeit two months after FDA first gave the green light to unregulated tests.
* “Serology tests have a number of limitations that may result in actual harm to public health," warned Dr. Jesse Ehrenfeld of the American Medical Association. For instance, many antibody tests have a high risk of false positives in areas with low prevalence of the coronavirus. Dr. Gigi Gronvall of Johns Hopkins University explained that “a false positive could lead a vulnerable person to be exposed to SARS-CoV-2, possibly endangering themselves and others."
* Dr. Rakeman, Laboratory Director for New York City’s Public Health Laboratory, stated that antibody tests cannot tell us whether someone “is immune to, or protected from, a subsequent infection with the virus." More scientific research is needed before the appropriate uses of antibody tests can expand.
Antibody tests are extremely useful to public health agencies for population-based prevalence studies, which give valuable information to researchers and public health officials.
* Dr. Gronvall explained that surveys can help us understand “the true case fatality rate" and “effects of mitigation strategies," informing decisions about “PPE resource allocation, mitigation efforts, and ultimately, vaccine procurement and prioritization.
* Dr. Rakeman added that population-based seroprevalence studies can help show the full impact of the disease across all communities, given that “diagnostic testing was not equitably available" earlier.
