Siemens Healthineers’ Covid-19 antibody test achieves CE mark

19 November 2020 (Last Updated November 19th, 2020 12:16)

Germany-based company Siemens Healthineers has received CE mark for its SARS-CoV-2 IgG antibody test, enabling its use across Europe and other regions.

Siemens Healthineers’ Covid-19 antibody test achieves CE mark
Neutralising antibodies are critical in the fight against Covid-19 because they defend cells from infection by the virus. Credit: swiftsciencewriting / Pixabay.

Germany-based firm Siemens Healthineers has received CE mark for its SARS-CoV-2 IgG antibody test, enabling its use across Europe and other regions.

The test has proven to measure neutralising antibodies, which are vital to fighting Covid-19 as they defend cells from viral infection.

The company has submitted an application to the US Food and Drug Administration (FDA) for emergency use authorisation (EUA).

Once vaccines for Covid-19 become available, the fully automated antibody tests can detect whether the vaccination programmes are working or not.

Identifying the presence of these neutralising antibodies and evaluating the level required to protect against future encounters with the virus is essential to analyse a vaccine’s effectiveness, Siemens noted.

An enhanced version of an assay launched recently across the world. The test measures the amount of neutralising antibodies in a patient’s blood sample and delivers quantitative results.

Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “We targeted the spike protein for our antibody tests, anticipating antibodies to this protein would eventually prove to be neutralising.

“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 tests are available globally on the largest installed bases of automated immunoassay analysers.

Siemens Healthineers also has a diagnostic that can help in the prognosis, treatment, and follow-up of Covid-19 patients apart from the antibody, antigen, and molecular tests.