[ad_1]
Abbott today announced that it has received the CE mark for its new SARS-CoV-2 IgG (immunoglobulin G) quantitative laboratory serology test. The IgG antibody test that provides a quantitative result (which measures the amount of antibodies) provides important information to people as they recover from COVID-19 and helps assess a person’s immune response to a vaccine.
Countries around the world are preparing for the authorization and distribution of COVID-19 vaccines. As these vaccines become available, healthcare professionals and researchers will need to assess how people and communities are responding.
The tests will continue to help both identify infected people and determine whether people have had a natural or vaccine-induced immune response. Quantitative antibody tests can help better understand a person’s immune response. “
John Hackett, Ph.D., Divisional Vice President of Applied Research and Technology for Abbott’s Diagnostics Business
The evolution of serological tests during COVID-19
During the first months of the pandemic, Abbott released its first COVID-19 IgG antibody blood test, which detects the virus’s nucleocapsid protein. Qualitative testing continues to provide a better understanding of people’s immune response to the virus, including the potential length of the recovery process. The new quantitative antibody test extends this knowledge by determining both the presence and the level (or titer) of antibodies present in the blood.
The Abbott scientists designed their quantitative assay to detect the spike protein of the virus, which plays an important role in the way the virus enters 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 the same immune response. Research has also shown a correlation between increasing levels of IgG that target the spike protein, such as those in Abbott’s quantitative test, and increasing levels of neutralizing antibodies or specific antibodies that block infections.1-2 Studies are being done to understand the relationship between a person’s antibody levels and potential immunity to the virus.
As we continue to learn more about the virus, antibody tests can help:
- Determine and monitor a person’s immune response to vaccines, including research to determine how long a response may last.
- Assessing whether a person’s antibody levels are the result of the body’s natural response to fighting the virus, versus a vaccine-induced response.
- Assess a person’s antibody level to help determine eligibility and potency for donations of convalescent plasma.
The Quantitative IgG Antibody Test is the latest in Abbott’s extensive portfolio of tests to assist the global healthcare community in the fight against COVID-19. Abbott’s range of COVID-19 tests includes molecular, antigenic and serological tests. These tests can help healthcare professionals detect the virus at all stages of its life cycle, including tests performed in the laboratory and rapid tests performed at the point of care.
About the SARS-CoV-2 IgG II Quantitative Antibody Test
Abbott’s Quantitative IgG Antibody Test is designed to detect levels of IgG antibodies that adhere to the virus spike protein on the virus surface in serum and plasma of persons suspected of having COVID-19 or in serum and Plasma from subjects who may have been infected with SARS-CoV-2.
A study to determine the clinical performance of Abbott’s SARS-CoV-2 IgG II quantitative test on its Alinity i instrument found that it had a specificity of 99.60% (ability to exclude false positives) and a sensitivity of 99.35%. (ability to exclude false negatives) in patients assessed 15 days or more after symptoms began.
The quantitative IgG test will be available on the Abbott ARCHITECT and Abbott Alinity i platform.
