Research and development company Battelle announced Tuesday that it had 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 allows the company to test samples from vaccine clinical trials. Assays determine the presence, amount, or function of a substance in a sample. They are used in diagnostics to assess the effectiveness of potential therapies or to determine the immune response in vaccine candidates. When the novel coronavirus emerged last year, no assays existed for it.
“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.”
Funded through the National Institute of Allergy and Infectious Diseases, part of the Department of Health and Human Services National Institutes of Health, the company has worked on process improvements and assay validation and provided the assay to other research organizations working on the federal response to COVID-19.
The company said it is also working with Duke University to validate its pseudovirus assay.
“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.”