FDA grants emergency use approval of Abbott's COVID-19 antibody test

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A healthcare worker giving test to a person in a car.

FDA grants emergency use approval of Abbott's COVID-19 antibody test

By Sandra Levy - 05/11/2020

Abbott has received the Food and Drug Administration’s Emergency Use Authorization 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 United States, United Kingdom, 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 Ford, Abbott president and CEO. "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.

This is Abbott's fourth COVID-19 test to receive EUA from the FDA, helping to provide hospitals and labs across the United States with broad, reliable molecular and antibody testing during this pandemic.