Siemens Healthineers announced that its SARS-CoV-2 IgG Antibody Test (sCOVG)1 has achieved CE Mark status for the test’s ability to measure neutralizing antibodies. The company also has applied for an emergency use authorization (EUA) from the U.S. Food and Drug Administration.
The test is an enhanced version of the assay, which became available globally this summer, including in the United States. It demonstrates the ability to detect neutralizing antibodies and reports quantitative results, measuring the concentration of neutralizing antibodies present in a patient's blood sample.
Neutralizing antibodies 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.
At a news conference, Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers, said he believes the demand for antibody testing will increase as vaccines against the virus become available. He said there are three use cases: to see if someone already has developed antibodies and should be a lower priority for receiving a vaccine, to measure antibody levels between doses of a vaccine, or to measure how long someone’s immunity lasts.
In a press release Nath added, "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. Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain."
The Siemens Healthineers SARS-CoV-2 IgG antibody tests are available on automated immunoassay analyzers, including the Atellica Solution, ADVIA Centaur XP and XPT families of analyzers, and the Dimension Vista and Dimension EXL systems.
