December 15, 2020 – Abbott (Abbott Park, IL) 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 amount of antibodies) provides important insights to people as they recover from COVID-19 and helps evaluate a person’s immune response to a vaccine, the company says.
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 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 in order 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 neutralizing antibodies, or the specific antibodies that block infections. 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 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 done at the point of care.
The quantitative IgG test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and plans to submit for U.S. Food and Drug Administration (FDA) emergency use authorization soon.