Funded by the National Institutes of Health (NIH), researchers at Department of Energy (DOE) partner Battelle have developed a microneutralization assay that uses live SARS-CoV-2 virus to analyze the neutralizing response against the virus in human serum samples. The assay is particularly useful for testing samples from vaccine clinical trials.
It’s one of several Battelle research projects Battelle is tackling to fight COVID-19, including vaccine development, decontamination technologies, and studies that show the persistence of the virus on library and museum materials. Battelle also developed SARS-C0V-2 diagnostic testing to support the state of Ohio's surveillance, and has adopted an FDA-authorized saliva test to identify and isolate critical support staff and maintain business continuity.
With funding through an existing National Institute of Allergy and Infectious Diseases (NIAID) contract, Battelle has worked on process improvements and assay validation, as well as transferring the assay for use by other contract research organizations supporting the federal response to COVID-19.
Assays - which determine the presence, amount, or function of a substance in a sample - are critically important in COVID-19 research. They are used in diagnostics to assess the effectiveness of potential therapeutics and to determine immune response to vaccine candidates. When the novel coronavirus that causes COVID-19 emerged a year ago, no assays existed for it. Researchers around the world, including teams at Battelle, raced to develop methods for detecting both the virus and the antibodies that fight it in saliva, blood, and other bodily fluids.
“The basis for the assay is from previous work we’ve done,” said Jennifer Garver, a Battelle biologist. “As soon as we heard about the pandemic, we knew we could design an assay that would be useful and desirable to test samples.”
A team of researchers spent a few months working on the best way to achieve sensitive results with a readout that would take less time and allow for high throughput. Battelle also is using this microneutralization assay to analyze Phase 1, 2, and 3 clinical samples to support serum testing from several key vaccine sponsors.
The urgency to find solutions to the COVID-19 pandemic has accelerated the pace of information sharing among research institutions. On a contract from the Biomedical Advanced Research and Development Authority (BARDA), Battelle is validating a pseudovirus assay developed by Duke University.
“The assay has the same principles as Battelle’s microneutralization assay but uses a surrogate virus form instead of the live SARS-CoV-2 virus,” said Chris Cirimotich, a Battelle biologist. “This means it can be used in BSL-2 laboratories instead of high-containment BSL-3 laboratories, which can also potentially increase capacity.”
Battelle also is transferring in an assay originally developed at NIAID’s Vaccine Research Center. This assay detects the antibodies produced following COVID-19 vaccination that binds to the virus. The assay involves a significant amount of automation, which has provided the opportunity to work with new equipment and processes. The team has been working closely with equipment providers to develop ideas to better utilize the hardware and expand the types of tests that can be automated.