Abbott COVID-19 Antibody Blood Test on Alinity i System Granted FDA Emergency Use Authorization
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By LabMedica International staff writers Posted on 12 May 2020 |
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Image: Abbott`s ARCHITECT platform (Photo courtesy of Abbott)
Abbott (Lake Forest, IL, USA) has secured the US Food and Drug Administration’s (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
The Alinity i system is Abbott's next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. Abbott also expects to shortly submit for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test. Abbott is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing. A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG assay found it had greater than 99.6% specificity (ability to exclude false positives) and 100% sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began.
This is Abbott's fourth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the US with broad, reliable molecular and antibody testing during the pandemic. In April, Abbott had received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system. The company has already begun shipping antibody tests for use on the ARCHITECT systems globally, including in the US, UK, Italy, Spain and India. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June.
"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," said Robert B. Ford, president and chief executive officer, Abbott. "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."
The Alinity i system is Abbott's next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. Abbott also expects to shortly submit for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test. Abbott is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing. A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG assay found it had greater than 99.6% specificity (ability to exclude false positives) and 100% sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began.
This is Abbott's fourth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the US with broad, reliable molecular and antibody testing during the pandemic. In April, Abbott had received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system. The company has already begun shipping antibody tests for use on the ARCHITECT systems globally, including in the US, UK, Italy, Spain and India. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June.
"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," said Robert B. Ford, president and chief executive officer, Abbott. "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."
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