The Siemens Healthineers SARS-CoV-2 IgG Antibody Test, available under CE Mark, has proven to measure neutralizing antibodies. The company has submitted to the FDA under EUA.
Siemens Healthineers announced in November 2020 its SARS-CoV-2 IgG Antibody Test (sCOVG) has proven to measure neutralizing antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer, including in the US. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the number of neutralizing antibodies present in a patient’s blood sample. The company has submitted an application to FDA under Emergency Use Authorization.
Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection by the virus. A virus typically produces an immune response of many antibodies that act as an army to help fight off the virus; however, only a small subset of those antibodies is capable of neutralization—blocking the virus from infecting additional cells. Those neutralizing antibodies develop either in response to natural infection or to vaccination, then subsequently bind to the virus and block infection. To measure a vaccine’s effectiveness, it is critical to identify both the presence of these neutralizing antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus. The Siemens Healthineers’ 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,” said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. “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.”
The Siemens Healthineers SARS-CoV-2 IgG antibody tests are available on one of the largest installed bases of automated immunoassay analyzers worldwide, and the largest in the U.S. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analyzers and the Dimension Vista® and Dimension® EXL™ systems.
Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients. [APBN]