Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system
Abbott has been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG lab-based serology blood test, a COVID-19 antibody blood test, on the Alinity i system.
The US medical device company will look to ship close to 30 million antibody tests across the world this world across its ARCHITECT and Alinity i platforms and will have the capacity for 60 million tests next month.
According to Abbott, antibody testing will help offer a greater understanding of the coronavirus, including how long antibodies can stay in the body and how much of the population has contracted the infection.
In April, Abbott was given FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system. The medical device company said that has already started shipping antibody tests for use on the ARCHITECT systems across the world including in the US, UK, Italy, India, and Spain.
Abbott gets FDA EUA for COVID-19 antibody blood test on Alinity i system. Photo courtesy of Abbott.
Robert B. Ford – president and CEO of Abbott said: “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.
“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.”
Abbott said that the Alinity i system is its next-generation immunoassay instrument, which has been designed to provide greater efficiencies to lab clinicians running tests. Alinity i systems are being used across the globe in hospital and academic centers and also reference laboratories.
The medical device company also anticipates submitting this week for CE Mark for the Alinity i SARS-CoV-2 IgG test to the IVD Directive (98/79/EC) in the European Union.