Abbott Receives CE Mark for New Quantitative SARS-CoV-2 IgG Lab-Based Serological Test

December 18, 2020

Abbott today announced that it has obtained the CE mark for a new quantitative SARS-CoV-2 IgG (immunoglobulin G) lab-based serological test. IgG antibody tests that give quantitative results (measuring the amount of antibody) provide important insights for people recovering from COVID-19 and help assess a person’s immune response to the vaccine.

Countries around the world are preparing to approve and distribute the COVID-19 vaccine. With the availability of these vaccines, healthcare professionals and researchers will need to assess how individuals and communities are reacting.

The test will not only help identify the infected person, but will continue to help determine if a person has shown a natural or vaccine-induced immune response. Quantitative antibody testing helps to better understand a person’s immune response. “

Dr. John Hackett, Vice President of Applied Research Technology, Abbott’s Diagnostic Business

Evolution of serological tests in COVID-19

During the early months of the pandemic, Abbott began the first COVID-19 IgG antibody blood test to detect the viral nucleocapsid protein. Qualitative testing continues to provide a better understanding of people’s immune response to the virus, including the potential duration of the recovery process.New quantitative antibody tests extend this knowledge by determining both presence and level (or titer) Of the antibodies present in the blood.

Abbott scientists have designed a quantitative assay to detect viral spike proteins. It plays an important role in the way the virus invades cells. When the body develops an immune response, antibodies develop and bind to the spikes of the virus, blocking proteins and ultimately preventing infection.

Some vaccines are designed using spike proteins that provoke the same immune response.Studies have shown elevated IgG levels targeting spike proteins, such as Abbott’s quantitative testing. Neutralizing antibody, Or a specific antibody that blocks the infection. Research is underway to understand the relationship between human antibody levels and potential immunity to the virus.

As you continue to learn more about viruses, antibody testing can help.

• Determine and monitor a person’s immune response to the vaccine. This includes studies to determine how long the response may last.
• Assess whether a person’s antibody levels are the result of the body’s natural response to the fight against the virus or a vaccine-induced response.
• Evaluate individual antibody levels to help determine eligibility and efficacy of convalescent plasma donations

Quantitative IgG antibody testing is the latest in Abbott’s extensive testing portfolio to support the global healthcare community in the fight against COVID-19. Abbott’s COVID-19 test portfolio includes molecules, antigen And serology tests. These tests help healthcare professionals detect viruses at all stages of their life cycle, including laboratory tests and point-of-care rapid tests.

About SARS-CoV-2 IgG II Quant antibody test

Abbott’s quantitative IgG antibody test was performed on the serum and plasma of individuals suspected of having COVID-19, or on the serum and plasma of subjects who may have COVID-19, and on virus-spiked proteins on the surface of the virus. It is designed to detect the level of IgG antibody that is applied. I am infected with SARS-CoV-2.

In a study determining the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on Alinityi instruments, 99.60% specificity (ability to exclude false positives) and 99.35% sensitivity (excluding false negatives) in the tested patients I found that I have the ability to do) more than 15 days after the onset of symptoms.

Quantitative IgG tests are available on both the Abbott ARCHITECT and Abbott Alinityi platforms.