On May 12, 2020, Abbott announced the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for the company’s molecular test for the novel coronavirus (COVID-19) for use on its new Alinity m molecular laboratory instrument. Abbott was in the process of launching the Alinity m system to U.S. customers.

The Alinity m system was cleared by the FDA for use with Abbott’s HCV (hepatitis C) assay in late March. Abbott is working with hospitals and health systems in the U.S. to install this new instrument, which will help keep up with the growing demand for testing.

The Alinity m system is Abbott’s most advanced laboratory molecular instrument. It is an automated platform, which can run more tests in less time to give laboratories improved efficiency and flexibility when using the system. The Alinity m system is able to run up to 1,080 tests in 24 hours, and their m2000 RealTime system can run up to 480 tests in 24 hours.

With current systems, running different types of tests at the same time will slow down the time to results and/or volume throughput. 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’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.