Industry News: Abbott obtains CE mark for COVID-19 laboratory-based antibody test

The test will be available for qualified laboratories across the European Union by the end of May

29 Apr 2020

Abbott has announced it received CE Mark to the IVD Directive (98/79/EC) for its laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19). Antibody testing is an important next step to tell if someone has been previously infected. It will provide more understanding of the virus including how long antibodies stay in the body and if they provide immunity. This type of knowledge could help support the development of treatments and vaccines.

This antibody test adds to Abbott's existing COVID-19 tests in the UK that are already being used on its m2000™ molecular laboratory system, which is already in use across NHS laboratories.

"Abbott has been focused on bringing COVID-19 tests to market as quickly as possible to help address this pandemic," said Mike Clayton, managing director Northern Europe diagnostics, Abbott. "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."

Antibody tests to expand testing

While molecular testing detects whether someone has the virus, antibody tests determine if someone was infected.

Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain up to months and possibly years after a person has recovered. The test demonstrated specificity and sensitivity to detect IgG antibodies of greater than 99 percent 14 days or more after symptoms started.

Abbott's IgG antibody test will initially be available on its ARCHITECT® i1000SR and i2000SR laboratory instruments.* ARCHITECT is one of the most widely used laboratory systems in the world and it's been used for decades. Over 250 of these instruments are in use in laboratories throughout the UK. These instruments can run up to 100-200 tests per hour.  

Abbott is significantly scaling up its European manufacturing for antibody testing and will expand testing to its Alinity™ i system. Abbott will also be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.

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