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Abbott receives CE Mark for its COVID-19 test

The IgG quantitative antibody blood test provides insights to people as they recover from COVID-19 and helps evaluate a person’s immune response to a vaccine

Abbott has received CE Mark for its new quantitative SARS-CoV-2 IgG (Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a quantitative result (measuring the number of antibodies) provides insights to people as they recover from COVID-19 and helps evaluate a person’s immune response to a vaccine. 

Countries around the world are preparing for the authorisation and the distribution of COVID-19 vaccines. As these vaccines become available, healthcare professionals and researchers will need to assess how individuals and communities are responding. 

“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,” said John Hackett, Divisional Vice President of Applied Research and Technology for Abbott’s diagnostics business. “Quantitative antibody testing can help provide a greater understanding of a person’s immune response.”

During the early months of the pandemic, Abbott launched its first COVID-19 IgG antibody blood test, which detects the nucleocapsid protein of the virus. The qualitative test continues to provide a better understanding of people’s immune response to the virus, including the potential duration of the recovery process. The new quantitative antibody test expands on this knowledge by determining both the presence and level (or titer) of antibodies present in the blood. 

Abbott’s scientists designed its quantitative assay to detect the spike protein of the virus, which plays an important part in how the virus enters the cells. As the body develops an immune response, antibodies develop and bind to the spike portion of the virus to block the protein and ultimately prevent infection. 

Several vaccines are designed with the spike protein to trigger that same immune response. Research has also shown a correlation between rising IgG levels that target the spike protein, such as those in Abbott’s quantitative test, and rising levels of neutralising antibodies, or the specific antibodies that block infections.1-2 Studies are underway to understand the relationship between the levels of antibodies a person has and potential immunity from the virus. 

The quantitative IgG antibody test is the latest in Abbott’s broad portfolio of tests to support the global healthcare community in the fight against COVID-19. Abbott’s COVID-19 test portfolio includes molecular, antigen and serology tests. These tests can help healthcare professionals detect the virus at all stages of its life cycle, including tests that are done in the lab as well as rapid tests were done at the point of care. 

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