Abbott Laboratories Inc. has launched a new antibody test to identify people who have been infected with COVID-19.
Abbott's SARS-CoV-2 IgG test is the third COVID-19 diagnostic developed by the company. Last month, it launched a real-time polymerase chain-reaction test, Abbott m2000 RealTime SARS-CoV-2 test, and a rapid, point-of-care test for its ID NOW platform (Also see "Abbott Launches Five-Minute POC Rapid COVID-19 Test" - Medtech Insight, 27 Mar, 2020.)
The new test identifies the IgG antibody, a protein produced by the body’s immune system in the late stages of coronavirus infection. The test will initially be available on Abbott’s Architect i1000SR and i2000SR laboratory instruments which can run up to 200 tests per hour.
Abbott said it expects to ship a total of 4 million tests in April and expand laboratory antibody testing to the detection of the IgM antibody.
Abbott will initially make the test available by following the U.S. Food and Drug Administration's notification without an emergency use authorization pathway established in new guidelines announced on 16 March. Abbott said it plans to file for an EUA with the FDA and for a CE Mark in the European Union. Multiple companies, including Becton Dickinson & Co.., Cellex Inc. and Ortho-Clinical Diagnostics Inc. are launching serology tests to detect SARS-CoV-2 antigens or antibodies under the new guidelines. (Also see "COVID-19: Nanomix Wins BARDA Funding For Mobile Point-Of-Care Assay" - Medtech Insight, 8 Apr, 2020.)
Antibody testing will be a critical step in tackling the coronavirus pandemic as tracking the population that has already been infected may allow some people to return to work and help re-open the economy.
The UK’s Medicines and Healthcare products Regulatory Agency published specifications for at-home and point-of-care serology COVID-19 tests after none of the self-tests acquired by the UK government met its standards. (Also see "UK Publishes COVID-19 Self-Test Specifications" - Medtech Insight, 9 Apr, 2020.)
The Belgian government has banned self-tests, including antibody tests, as it considers these test insufficiently accurate to be used in the pandemic. (Also see "Belgium Bans COVID-19 Antibody Self-Tests But UK Goes Ahead" - Medtech Insight, 31 Mar, 2020.)
Medtech Insight is tracking the global diagnostic pipeline of COVID-19 tests. See our COVID-19 test tracker for a full listing.