The collaboration with the CDC and Europe’s Joint Research Centre (JRC) is slated to develop a novel process for standardizing the SARS-CoV-2 antibody tests as they differ among manufacturers and currently can’t e analytically compared because they target different SARS-CoV-2 proteins, according to a news release.
As the COVID-19 pandemic has evolved, the collaboration says that antibody test results have progressed from positive/negative results to assays capable of numerical measurements that calculate the level of IgG antibodies in a blood sample.
Because test results across the multitude of assays out there isn’t possible, it’s difficult to establish immunity associated with those tests. The collaboration aims to standardize the assays through anchoring each protein to a neutralization antibody titer (a level of antibody present to block the virus from entering cells).
Siemens Healthineers, the CDC and the JRC believe that a standardized process will define which concentration confers neutralization for different manufacturers’ antigen targets, establishing a reference material so that clinicians can track their patients’ antibody concentrations regardless of the test method or manufacturer used.
The collaborators expect that standardization would enable long-term antibody level comparison that opens up avenues for verifying natural immunity and determining the effectiveness of vaccines.
“One barrier to antibody test adoption is we don’t currently have an established process to determine immunity,” said Siemens Healthineers president of laboratory diagnostics Deepak Nath said in the news release. “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.
“Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves.”