Siemens Healthineers yesterday announced its SARS-CoV-2 IgG Antibody Test (sCOVG)1 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 U.S. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results measuring the amount of neutralizing antibodies present in a patient’s blood sample. The company has submitted an application to FDA under Emergency Use Authorization.
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.
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 are 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. Siemens Healthineers says 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.
The Siemens Healthineers said its 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.
Kalorama Information has recently produced a report on COVID-19 testing. The report is available at: https://kaloramainformation.com/product/covid-19-update-clinical-testing-telehealth-vaccines-and-other-markets/