Abbott’s Covid-19 IgG quantitative antibody blood test obtains CE Mark

16 December 2020 (Last Updated December 16th, 2020 10:40)

Abbott has received CE Mark for its new quantitative SARS-CoV-2 Immunoglobulin G (IgG) lab-based serology test that can measure a person’s immune response.

Abbott’s Covid-19 IgG quantitative antibody blood test obtains CE Mark
Abbott plans to seek EUA from the US FDA for the test soon. Credit: National Cancer Institute / Unsplash.

Abbott has received CE Mark for its new quantitative SARS-CoV-2 Immunoglobulin G (IgG) lab-based serology test that can measure a person’s immune response.

The SARS-CoV-2 IgG II Quant antibody test can detect IgG antibodies that attach to the virus’ spike protein on the virus surface in serum and plasma from individuals who are suspected of having or have Covid-19.

IgG antibody testing measures antibody levels and provides a quantitative result to help understand how an individual is recovering from Covid-19.

Furthermore, the tests can be used to monitor a person’s immune response to vaccines and check a person’s antibody level to help analyse eligibility and potency for convalescent plasma donations.

The test will be available on Abbott’s ARCHITECT and Alinity i platforms.

A study to analyse the clinical performance of the test on Abbott’s Alinity i instrument showed that the test had 99.60% specificity and 99.35% sensitivity in patients tested 15 days or more after the symptoms began.

Abbott diagnostics business Applied Research and Technology divisional vice-president John Hackett said: “Testing will continue to help both identify those who are infected, as well as determine whether people have had a natural or vaccine-induced immune response.

“Quantitative antibody testing can help provide a greater understanding of a person’s immune response.”

The company intends to seek emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the test soon.

Apart from the test, Abbott has molecular, antigen, and serology tests in its Covid-19 test portfolio.

The tests can be carried out in the laboratory and at the point of care. They will enable healthcare specialists to detect the virus at all stages of its life cycle.

In May, Abbott received EUA from the FDA for its Covid-19 molecular test for use on its new Alinity i molecular lab system.