Abbott has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
The healthcare company aims to supply around 30 million antibody tests around the globe this month. These tests can run on the Architect and Alinity i platforms.
Abbott is planning to supply around 60 million Covid-19 tests in June
Abbott is planning to supply around 60 million tests in June. Antibody testing will enable to better understand the virus, including how long antibodies reside in the body and how much of the population has been infected.
The Alinity i system is the company’s next-generation immunoassay instrument, which has been developed to help lab clinicians efficiently run tests.
Abbott is also planning to submit an application for CE mark approval in the European Union for the Alinity i SARS-CoV-2 IgG test.
In April, Abbott secured FDA EUA status and CE mark approval for its SARS-CoV-2 IgG antibody blood test on the Architect system.
The company has already started supplying antibody tests for use on the Architect systems across the globe, including in the US, UK Italy, Spain, and India.
Abbott president and CEO Robert Ford 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.”
In March, Abbot secured FDA EUA status for its fastest available molecular point-of-care test to detect Covid-19 disease.
Abbott’s fastest available molecular point-of-care test holds the capacity to deliver positive results within five minutes and negative results in 13 minutes.
