On May 11, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) issued an 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.

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.

Abbott is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing. This is Abbott’s fourth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad, reliable molecular and antibody testing during this pandemic.

Abbott’s Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed to be more efficient – running more tests in less space and minimizing human errors – while continuing to provide quality results. The availability of the Alinity systems and tests varies by geography.