Abbott announced that 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.
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.
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.