Reports in the United Kingdom say that a 99% accurate COVID-19 antibody test produced by Abbott (NYSE:ABT) won CE Mark approval for use across Europe.
The Abbott Park, Ill.-based company, which has a base in Maidenhead, England, expects to have shipped millions of its lab-based tests across Europe by the end of May, according to a report in The Independent.
Abbott’s test identifies the IgG protein in bodies that are infected by COVID-19, showing 99% sensitivity 14 days after symptoms were developed in 73 coronavirus-positive patients, according to the report. It also showcased 99% specificity in identifying that 1,070 negative samples did not contain COVID-19 antibodies.
According to the report, Abbott is significantly scaling up its European manufacturing for antibody testing while also developing testing for detecting the IgM antibody.
“Abbott has been focused on bringing Covid-19 tests to market as quickly as possible to help address this pandemic,” Abbott’s northern Europe diagnostics division managing director Mike Clayton said in the report. “We are proud to be able to provide our antibody tests immediately as they will help understand who has had the virus, leading to greater confidence as we get back to living life. We are collaborating with the NHS, public health bodies and private laboratories across the UK to enable this test to be used here.”
Abbott announced yesterday that it launched its third antibody test, the same one for detecting the IgG protein, in the U.S. It can be used on Abbott’s Architect i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests an hour, according to a news release.
The company plans to ship 20 million of its antibody tests in June as it looks to expand its testing capabilities to its Alinity i lab system.
“Antibody testing has the potential to unlock a lot of unknowns about this novel virus,” Abbott diganostics applied research & technology divisional VP John Hackett said in the release. “Having tests that can work in different healthcare settings is critical to our understanding of the virus and to helping give healthcare providers answers they need about their patients.”