Siemens Healthineers has been at the forefront of the COVID-19 testing since the pandemic struck the U.S. The Erlangen, Germany-based company continued the trend this week by announcing it was offering a quantitative COVID-19 test to measure neutralizing antibodies.
The SARS-CoV-2 IgG Antibody test is an enhanced version of the assay the company launched in August. The “enhanced” assay has been granted CE mark and Siemens Healthineers has submitted an application to FDA for emergency use authorization.
As COVID-19 vaccines are coming into fruition, it is going to be imperative to identify the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus. Siemens Healthineers said its antibody test will make learning this information possible as vaccines are rolled out and exposure to COVID-19 is tested against immunization and the level of immunity a vaccine provides.
"At the onset of the pandemic, the scientific community had to learn about COVID-19 and how our immune systems would respond. We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralizing," Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers, said in a release. "Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor-binding domain. Healthcare providers can feel confident that our test will help them determine whether a patient's immune system is producing the right antibodies to stop or prevent COVID-19 infection."
Siemens Healthineers has been a vital part of the testing conversation. It was one of the first companies to obtain EUA for a COVID-19 test.
In September, the company teamed up with the Centers for Disease Control and Prevention along with the Joint Research Centre of the European Commission to standardize antibody tests.
The partnership formed because antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins.
Siemens Healthineers is developing the process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block the virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.