- The Siemens Healthineers SARS-CoV-2 IgG Antibody Test, available under CE Mark, has proven to measure neutralising antibodies. The company has submitted to the FDA under EUA.
- As SARS-CoV-2 vaccines become available, Siemens Healthineers is ready with fully automated antibody tests that can be used to help inform whether broad vaccination programmes are working.
- Reliable antibody tests are a valuable tool to measure the effectiveness of vaccines.
Siemens Healthineers has announced its SARS-CoV-2 IgG Antibody Test (sCOVG)1 has proven to measure neutralising antibodies and has achieved CE Mark. The test is an enhanced version of the assay which became available globally this summer. It demonstrates the ability to detect neutralising antibodies and reports quantitative results measuring the amount of neutralising antibodies present in a patient's blood sample. The company has also submitted an application to FDA under Emergency Use Authorisation in the USA.
Neutralising 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 are capable of neutralisation—blocking the virus from infecting additional cells. Those neutralising 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 neutralising antibodies as well as quantitatively assess the likely level needed to protect against future encounters with the virus. The antibody test from Siemens Healthineers will make learning this information possible as vaccines are rolled out and exposure to COVID-19 is tested against immunisation 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 neutralising," states Stewart Hutton, Business Lead for Laboratory Diagnostics at Siemens Healthineers GB&I. "Adequate data is available now to confirm the spike protein antibodies are indeed neutralising, 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 analysers worldwide. This includes the Atellica® Solution and ADVIA Centaur® XP and XPT families of analysers 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 haematology, 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.