Medical technology company Siemens Healthineers has secured emergence use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG (COV2G) antibody test.
The COV2G is said to be the first antibody test authorised with a semi-quantitative detection claim and the firm’s fifth antibody test to secure EUA that delivers sensitivity and specificity of more than 99%.
Siemens’ COV2G antibody test provides both a positive or negative result for IgG antibodies, as well as delivers a numerical result that can be expressed as the index value.
The semi-quantitative Covid-19 test has already secured CE-mark approval and is currently available across the globe.
According to the company, the semi-quantitative result allows clinicians to gauge the level of IgG antibodies in a patient’s blood sample.
The numerical value helps clinicians to establish a baseline and efficiently evaluate changes of an individual’s immune response to the SARS-CoV-2 virus.
The specific antibodies will develop at different stages of the infection when an individual is infected with the SARS-CoV-2 virus.
Siemens’ SARS-CoV-2 total antibody test will detect antibodies to IgM and IgG
Siemens’ SARS-CoV-2 total antibody test has the capacity to identify antibodies to IgM and IgG, which are present both early and later during the immune response. It will specifically identify IgG antibodies that persist and serve as basis for an individual’s longer term immune response.
The antibody tests will allow to determine prior exposure to the virus by detecting antibodies that may neutralise the virus, as well as identify donors of convalescent plasma.
Siemens Healthineers’ laboratory diagnostics president Dr Deepak Nath said: “Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic.
“Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight Covid-19.”
Recently, Siemens Healthineers has signed an agreement to acquire cancer care technologies and solutions provider Varian in a deal valued at around $16.4bn.
