Abbott (NYSE:ABT) announced today that it received CE Mark approval for its new SARS-CoV-2 IgG lab-based serology test.
The Abbott Park, Ill.-based company’s IgG antibody test for the virus causing COVID-19 offers a quantitative result to help evaluate a person’s immune response to a vaccine, according to a news release.
Abbott’s quantitative IgG antibody test detects levels of IgG antibodies that attach to the virus’ spike protein on the virus surface in serum and plasma from those suspected to have had COVID-19 or subjects who may have been infected by SARS-CoV-2.
The Abbott SARS-CoV-2 IgG II Quant test, run on the company’s Alinity i instrument demonstrated 99.6% specificity and 99.35% sensitivity in patients tested 15 days or more after symptoms began.
Quant will be available on both Abbott’s Architect and Alinity i platforms, while the company is developing a test and planning to submit for FDA emergency use authorization soon.
“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,” Abbott diagnostics divisional VP of applied research & technology John Hackett said in the news release. “Quantitative antibody testing can help provide greater understanding of a person’s immune response.”