Abbott Receives FDA’s Emergency Use Authorization for its Fourth Ab Blood Test to Detect COVID-19

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  • Abbott’s SARS-CoV-2 IgG lab-based serology blood test is the fourth COVID-19 detection test to receive the FDA’ EUA based on Alinity i platforms, which is a next-generation immunoassay instrument offering efficiency to lab clinicians for running tests
  • SARS-CoV-2 IgG lab-based serology blood test is a reliable test for customers and patients to detect Abs with >99.6% specificity and 100% sensitivity in patients tested 14 days post COVID-19 symptoms. Abbott’s SARS-CoV-2 IgG Ab blood test on the ARCHITECT system received the US FDA’s EUA and CE Mark and is also shipped in the US, UK, Italy including Spain and India
  • Abbott will ship 30M Ab tests globally by May 2020 with capacity of 60M in Jun 2020 across its ARCHITECT and Alinity i platforms with expected submission for the CE mark to the IVD Directive (98/79/EC) in EU by this week for Alinity i SARS-CoV-2 IgG test

Click here to read full press release/ article | Ref: Abbott | Image: Behance

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