Thermo Fisher Scientific Gains CE Mark Certification for New OmniPATH Combi SARS-CoV-2 IgG ELISA Test


Thermo Fisher Scientific, the world leader in serving science, has secured CE Mark certification for the Thermo Scientific OmniPATH Combi SARS-CoV-2 IgG ELISA test. The test is intended for the quantitative measurement of immunoglobulin G (IgG) antibodies raised against the spike protein of the SARS-CoV-2 virus to aid clinicians in identifying patients with an immune response pre- and post-vaccination.

The ability to quantify IgG is a critical component to understanding an individual’s immune response to the SARS-CoV-2 virus, especially as we start to vaccinate the population. Having quantitative data on neutralizing antibodies will enable better understanding of a person’s immune response following exposure to the COVID-19 virus and support monitoring of the effectiveness of vaccines as they become available.

Dr. Sarah Walker, Professor of Medical Statistics and Epidemiology at the University of Oxford and Chief Investigator of the National COVID-19 infection survey said: “Using this test within the COVID-19 Infection Survey allows us to answer vital questions about the role of previous infection and varying levels of antibody response in protecting people from getting infected again in the future. As we follow individuals over the course of a year, we are repeatedly testing them for both virus and antibodies.”

Thermo Fisher joined forces with the University of Oxford to harness their academic research capabilities in identifying the spike protein. This, coupled with Thermo Fisher’s manufacturing capability and immunoassay expertise, enabled the development of both a 96 and a 384 microplate assay format. The 384-well microplate assay is compatible with a newly developed automation system, designed by Thermo Fisher and enables the Oxford Univeristy to deliver COVID-19 testing capacity of up to 50,000 tests per day.

“Thermo Fisher Scientific is proud to have developed and delivered this CE marked product in collaboration with Oxford University,” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific. “Combining the academic research capabilities of world recognized 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’s new fully automated testing platform is already in use by Oxford University to provide weekly UK-wide data to the Office of National Statistics as part of the national COVID-19 Infection Survey. In addition, the equipment further enhances Oxford’s capacity to accurately quantify a patient’s vaccine response as part of the ongoing Oxford coronavirus vaccine clinical trial.

This new OmniPATH Combi SARS-CoV-2 IgG ELISA test assay is an extension of Thermo Fisher’s COVID-19 antibody test portfolio. In October, the company launched the OmniPATH COVID-19 Total Antibody ELISA test for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and IgG.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.