The test is designed for the quantitative measurement of immunoglobulin G (IgG) antibodies, produced against the SARS-CoV-2 virus spike protein


OmniPATH Combi SARS-CoV-2 IgG ELISA test assay is an extension of Thermo Fisher’s COVID-19 antibody test portfolio. (Credit: Belova59 from Pixabay.)

Thermo Fisher Scientific has received the CE Mark approval for its OmniPATH Combi SARS-CoV-2 IgG ELISA test, intended for identifying patients with immune responses before and after vaccination.

The test has been designed for the quantitative measurement of immunoglobulin G (IgG) antibodies, produced against the SARS-CoV-2 virus spike protein.

The company has teamed up with the University of Oxford to tap on their academic research capabilities in identifying the spike protein.

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 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.”

OmniPATH Combi SARS-CoV-2 IgG ELISA test used by Oxford University

According to the company, quantifying IgG is important in understanding a person’s immune response to the SARS-CoV-2 virus, specifically while vaccination is about to begin.

The quantitative data on neutralising antibodies provides better understanding of the person’s immune response after being exposed to the Covid-19 virus and would support the monitoring of the vaccine effectiveness.

Thermo Fisher’s new automated testing platform is already being used by Oxford University to provide UK-wide weekly data to the Office of National Statistics as part of the national Covid-19 Infection Survey.

National Covid-19 infection survey chief investigator Sarah Walker 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.”

The new test is said to further enhance Oxford’s capacity to precisely quantify the patients’ vaccine response as part of its ongoing Oxford coronavirus vaccine clinical trial.

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.