Thermo Fisher’s Covid-19 IgG antibody test obtains CE Mark

9 December 2020 (Last Updated December 9th, 2020 11:52)

Thermo Fisher Scientific has obtained CE Mark certification for its Covid-19 test for quantitative measurement of immunoglobulin G (IgG) antibodies raised against the spike protein of the SARS-CoV-2 virus.

Thermo Fisher’s Covid-19 IgG antibody test obtains CE Mark
Thermo Fisher partnered with the University of Oxford to use its academic research capabilities in detecting the spike protein. Credit: Thermo Fisher Scientific Inc.

Thermo Fisher Scientific has obtained CE Mark certification for its Covid-19 test for quantitative measurement of immunoglobulin G (IgG) antibodies raised against the spike protein of the SARS-CoV-2 virus.

The OmniPATH Combi SARS-CoV-2 IgG ELISA test will help clinicians to detect patients with an immune response before and after vaccination.

Quantifying IgG is essential to understand an individual’s immune response to the SARS-CoV-2 virus, particularly when vaccination starts.

Thermo Fisher Scientific executive vice-president and chief operating officer Mark Stevenson said: “Thermo Fisher Scientific is proud to have developed and delivered this CE marked product in collaboration with Oxford University.

“Combining the academic research capabilities of world-recognised scientists at Oxford University with Thermo Fisher’s Dartford UK development and manufacturing facility has expanded our serology portfolio for improved Covid-19 epidemiological studies.”

Thermo Fisher partnered with the University of Oxford in the UK to use its academic research capabilities in detecting the spike protein.

This, along with the company’s manufacturing capability and immunoassay expertise, led to the development of both a 96 and a 384 microplate assay format.

Compatible with a newly developed automation system by Thermo Fisher, the 384-well microplate assay enables Oxford University to provide Covid-19 testing capacity of up to 50,000 tests a day.

The platform is currently being used by Oxford University to provide weekly UK-wide data to the Office of National Statistics as part of the national Covid-19 Infection Survey.

Moreover, the equipment boosts the university’s capacity to correctly quantify a patient’s vaccine response in its Covid-19 vaccine trial.

University of Oxford Medical Statistics and Epidemiology professor and the National Covid-19 infection survey chief Investigator Dr Sarah Walker said: “Using this test within the Covid-19 Infection Survey allows us to answer vital questions about the role of the previous infection and varying levels of antibody response in protecting people from getting infected again in the future.”

In October, Thermo Fisher launched Gibco CTS Rotea Counterflow Centrifugation System, which enables scalable, cost-effective cell therapy development and manufacturing.