Abbott Granted FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity m System

Abbott (Lake Forest, IL, USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the company's molecular test for the novel coronavirus (COVID-19) for use on its new Alinity m molecular laboratory instrument.

This was Abbott's fifth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the US with broad, reliable molecular and antibody testing during this pandemic. The Alinity m system was cleared by the FDA for use with Abbott's HCV (hepatitis C) assay in late March.


The Alinity m system is an automated platform, which can run more tests in less time to give laboratories improved efficiency and flexibility. It is able to run up to 1,080 tests in 24 hours, while the company’s m2000 RealTime system can run up to 480 tests in 24 hours. Alinity m delivers true random access, allowing labs to run any test, any time for different types of infectious diseases while still providing results in less than two hours. This is especially critical during the COVID-19 pandemic when volume, speed and flexibility are needed. Abbott is working with hospitals and health systems in the US to install the new instrument, which will help keep up with the growing demand for testing.

"Molecular lab tests play a critical role in detecting the virus for COVID-19. As a leader in diagnostics, we are pushing forward to develop high-performing tests across our platforms to help combat this pandemic," said Robert B. Ford, president and chief executive officer, Abbott. "As we continue to develop and improve our testing technologies, we want to ensure they are meeting the needs of our customers – and right now that means having reliable tests for COVID-19 on all of our diagnostic instruments."