Abbott has obtained CE Mark for its new lab-based quantitative Covid-19 IgG serology test, to measure the levels of IgG antibodies, produced against SARS-CoV-2 virus.
Countries around the world are preparing for the approval and the distribution of the Covid-19 vaccine, and once available, healthcare professionals and researchers will evaluate how individuals and communities are responding.
Its SARS-CoV-2 IgG II Quant antibody blood test offers insights to people as they recover from Covid-19, and help understand a person’s immune response to a Covid-19 vaccine.
Abbott diagnostics business 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 greater understanding of a person’s immune response.”
Covid-19 IgG quant antibody test detects IgG antibodies on SARS-CoV-2 surface
The new quantitative IgG antibody test is designed to detect levels of IgG antibodies attached to the surface of SARS-CoV-2 spike protein in serum and plasma of individuals who are suspected of having Covid-19, or who are infected by SARS-CoV-2.
Abbott has conducted a study to evaluate the clinical performance of its SARS-CoV-2 IgG II Quant test on its Alinity i instrument.
The test showed that the new diagnostic test is capable of excluding 99.60% false positives, (specificity) and 99.35% false negatives (sensitivity) in patients, tested 15 days or more after the onset of symptoms.
The company is offering the quantitative Covid-19 IgG test on both the Abbott ARCHITECT and Alinity i platforms, and intends to seek US Food and Drug Administration (FDA) emergency use authorisation soon.
Abbott said that its new quantitative antibody test expands its first Covid-19 IgG antibody blood test, which detects nucleocapsid protein of the virus by determining both the presence and level of antibodies present in the blood.
Furthermore, the antibody test would help determine and monitor a person’s immune response to vaccines, and confirm if a person’s antibody levels are due to the body’s natural response or induced by a vaccine, and evaluate the level of antibodies.
