Siemens Healthineers Launches Improved COVID-19 Antibody Test

November 25, 2020 - Siemens Healthineers recently announced the launch of its COVID-19 antibody test, which has previously proven to measure neutralizing antibodies and has achieved CE Mark. 

Notably, the SARS-CoV-2 IgG Antibody Test (COV2G), is an enhanced version of the company’s assay, which became available globally this summer. The company stated that it recently submitted an emergency use authorization for the new and improved test to FDA. 

"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 the announcement. 

"Adequate data is available now to confirm the spike protein antibodies are indeed neutralizing, especially those against the spike receptor binding domain,” Nath said. “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."

At the end of July, FDA authorized the first two COVID-19 serology tests that displayed an estimated quantity of antibodies present in a patient’s blood.

Both tests from Siemens Healthineers, the ADVIA Centaur COV2G and Atellica IM COV2G, are known as “semi-quantitative” tests, which means they estimate the quantity of a patient’s antibodies that can fight COVID-19.

The COV2G tests became the fifth antibody test from Siemens Healthineers to receive authorization that showed specificity of greater than 99 percent. 

Currently, Siemens Healthineers antibody tests are available on one of the largest installed bases of automated immunoassay analyzers in the world in the US, as well as in countries that accept the CE mark worldwide, the company said. 

This includes the Atellica Solution and ADVIA Centaur families, as well as Siemens Healthineer’s Dimension Vista and Dimension EXL systems. 

Being able to measure a patient’s level of antibodies in response to a SARS-CoV-2 infection may be useful to researchers and experts so they can continue to learn more about COVID-19. 

“Neutralizing antibodies are critical in the fight against COVID-19 because they defend cells from infection by the virus,” Siemens Healthineers said.

“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,” the company concluded. 

Experts believe that if an individual develops antibodies to the novel coronavirus, then they may have at least temporary immunity from reinfection, although this is still unproven and the parameters of that immunity are still unknown.

In mid-November, FDA authorized a serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection.

The emergency use authorization went to biotechnology company GenScript for its cPass SARS-CoV-2 Neutralizing Antibody Detection Kit, the first test to be approved by FDA to specifically detect neutralizing antibodies in patient samples without the use of a live virus.

The agency authorized the test to be distributed and used by authorized laboratories under the emergency use authorization.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” Tim Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the November announcement. 

“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus,” Stenzel continued.