Sept. 29, 2020—Siemens Healthineers will collaborate with the Centers for Disease Control and Prevention and the Joint Research Centre of the European Commission on a research project to develop a novel process for standardizing SARS-CoV-2 assays.
“One barrier to antibody test adoption is we don’t currently have an established process to determine immunity,” Deepak Nath, PhD, president of laboratory diagnostics, Siemens Healthineers, said in press statement. “Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity.”
Siemens will collaborate with the CDC and JRC to develop the framework, he said, “that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves.”
Developing a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets. Each manufacturer now standardizes its assays independently with internal standards not linked to a common reference. The results of the project will support the JRC’s production of a reference material, which, with assigned concentrations of antibody specific to each viral protein, will allow manufacturers to refer to standardized values.