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Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System
May 13, 2020
Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT® and Alinity i™ platforms and will have capacity for 60 million tests in June.
Antibody testing will help provide a greater understanding of the virus, including how long antibodies stay in the body and how much of the population has been infected. Last month, Abbott received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system.* Abbott has already begun shipping antibody tests for use on the ARCHITECT systems globally including in the U.S., UK, Italy, Spain and India.
“Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19,” said Robert B. Ford, president and chief executive officer, Abbott. “Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity.”
The Alinity i system is Abbott’s next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. Alinity i systems are in use around the world in hospital and academic centers as well as reference laboratories. Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.
See Full Press Release: Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity™ i System
Written by: Abbott
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