Abbott has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its Covid-19 molecular test, used on the new Alinity m molecular laboratory instrument.
The US medical devices and health care firm has obtained the FDA approval for Alinity m system in March 2020, is working with hospitals to launch the new testing system in the US.
Abbott president and chief executive officer Robert Ford said: “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.
“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.”
Alinity m system allows laboratories to run more diagnostic tests in less time
Abbott’s advanced laboratory molecular instrument Alinity m system is an automated platform, capable of running more tests in less time and offer improved flexibility for laboratories.
The company said that its Alinity m system can run up to 1,080 tests in 24 hours, and m2000 RealTime system can run up to 480 tests in 24 hours. The systems can run different types of tests at the same time and would reduce the time required for results and volume throughput.
In addition, Alinity m device would allow labs to run any test, any time for different types of infectious diseases, and provide results in less than two hours.
The current regulatory EUA marks the company’s fifth FDA authorised Covid-19 test that provides US hospitals and labs with reliable molecular and antibody testing during the Covid-19 pandemic.
Alinity systems have been designed to be more effective, conduct more tests in less space and minimise human errors, while providing quality results.