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    Breaking News

    Abbott’s COVID-19 Antibody Blood Test Gains EUA for Use on Alinity i System

    Plans to ship nearly 30 million antibody tests globally in May across its Architect and Alinity i platforms.

    Abbott’s COVID-19 Antibody Blood Test Gains EUA for Use on Alinity i System
    A study to determine the clinical performance of Abbott's SARS-CoV-2 IgG assay found it had greater than 99.6% specificity and 100% sensitivity in patients tested 14 days after symptoms began.
    PR Newswire05.11.20
    On May 11, The FDA issued Emergency Use Authorization (EUA) for Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. 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.
     
    Antibody testing will help provide a greater understanding of the virus, including how long antibodies stay in the body and how much of the population has been infected. Last month, Abbott received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the Architect system. Abbott has already begun shipping antibody tests for use on the Architect systems globally including in the U.S., UK, Italy, Spain and India.
     
    "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. Alinity i systems are in use around the world in hospital and academic centers as well as reference laboratories. Abbott also expects to submit this week for CE Mark to the IVD Directive (98/79/EC) in the European Union for the Alinity i SARS-CoV-2 IgG test.
     
    Bringing Broad Scale Access to Reliable Testing
    Abbott says its goal is to bring highly reliable tests to customers and patients around the world. 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.
     
    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.
     
    This is Abbott's fourth COVID-19 test to receive FDA EUA, helping to provide hospitals and labs across the U.S. with broad molecular and antibody testing during this pandemic.
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    Breaking News
    • Babson Diagnostics’ BetterWay Achieves Regulatory Milestone
    • WhiteSwell Successfully Treats Acute Decompensated Heart Failure in Study
    • Everly Health Releases At-Home Collection Kidney Health Test
    • Kenco Adds Two to its Life Sciences Division Team
    • FDA Grants Breakthrough Device Status to Brain-Computer Interface
    View Breaking News >
    CURRENT ISSUE

    November 2023

    • MPO's 2023 Medical Device Industry Year in Review
    • The Beat Goes On in the Cardiovascular Device Market
    • Medical Manufacturers Gain Support from 3D Printing
    • The Intelligent Tools Medical Device Manufacturers Already Own
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