Public-private network ensures accuracy of COVID-19 antibody tests available in US market

 Frederick National Laboratory for Cancer Research (FNL) plays a central role in a public-private network that has kept scores of substandard COVID-19 blood antibody tests out of circulation and helped ensure that marketed tests give accurate results. 

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This critical pandemic response is detailed in a scientific study published January 12 in the journal Microbiology Spectrum. It concludes that this type of network could also be a model for evaluating other technologies, even outside of public health emergencies Douglas Lowy, M.D., principal deputy director of the National Cancer Institute (NCI) is senior author on the paper. Ligia Pinto, Ph.D., director of the Vaccine, Immunity and Cancer program at FNL, is lead author.

“None of this would have happened as rapidly as it did without the Frederick National Laboratory for Cancer Research and someone with Dr. Ligia Pinto’s expertise,” said Dr. James Cherry, Associate Director, Research Technologies at the National institute of Allergy and Infectious Diseases (NIAID), Senior Scientific Program Director with the NCI, and study coauthor. “These FFRDC authorities were the glue that brought all of this together.”

The study described the effectiveness of the network comprising FNL, the Food and Drug Administration, NCI, the Centers for Disease Control and Prevention, NIAID, the National Institutes of Health Clinical Center, and the Biomedical Advanced Research and Development Authority.

The partners came together in early 2020 after commercial blood tests began flooding the market to detect antibodies to SARS-CoV-2, the virus that causes COVID-19. Originally the FDA approved these tests under Emergency Use Authorities (EUA), including validation of the tests by the manufacturer.

But concerns arose after a number of tests performed poorly, and false claims began to circulate regarding FDA EUA approval. FDA tightened the validation requirement, but some companies had difficulty validating their tests in part because clinical samples were hard to identify early in the pandemic.

“The FDA proposed an independent evaluation program,” Pinto said., , .  Lowy knew Pinto’s FNL serology laboratory had unmatched expertise from its serology work on cancer-causing human papillomavirus and -- as part of a national laboratory -- could rapidly pivot to focus on coronavirus. NCI Director  Norman E. Sharpless, M.D. gave the go-ahead.

The public-private network used a well-characterized set of blood serum samples collected from patients infected with SARS-CoV-2 and a negative group of samples collected before the pandemic and known to be negative for anti-SARS-CoV-2 antibodies. The positive samples were further characterized for levels of antibodies for the spike protein that the virus uses to infect human cells. These samples were then used to evaluate the performance of serology tests and/or assays by determining the specificity and sensitivity of COVID-19 blood tests.

The research paper noted that results of 91 evaluations of 87 commercial COVID-19 blood tests have been released to the public at the FDA and CDC websites. Of those, FDA blocked or removed from the U.S. market 60 tests based on poor performance observed in the current study, combined with other factors. The agency has approved 27 COVID tests and continues to review commercial tests submitted for evaluation through this independent evaluation process.

The study noted that COVID blood tests that  received Emergency Use Authorization (EUA) from the FDA assess recent or past infection. They have not been approved to assess an immune response to a COVID-19 vaccination, “so results should be interpreted carefully.”

Pinto said each member of the public-private network brought critical resources and expertise to the effort, including but not limited to, clinical specimens, serology expertise, technology applications and enhancement, legal resources -- an armamentarium that could not have been assembled by any organization acting alone.

The partnership has played a critical and ongoing role in response to the coronavirus pandemic, Cherry said. It exploited the full power of the Frederick National Laboratory for Cancer Research and its ability to be flexible and rapidly respond to an urgent national priority and bring on partners and collaborators to address the pandemic.

“Everyone lowered their defenses and focused on the common enemy,” Cherry said. “We were all trying to figure out the best thing to do. Everyone wanted to help. All the walls came down. We united against the virus.”

The trans-governmental network created a framework and workflow that could help combat new outbreaks in the future, Pinto said. It could also be used more broadly to evaluate other technologies used outside of outbreaks.

To sustain the lessons learned and prepare for the next pandemic, NCI received additional funding to create a center for excellence to enable accurate testing and pandemic preparedness that will continue to create standards and establish a repository with large volume of well-characterized of blood samples.