Abbott Obtains CE Mark for Laboratory PCR Assay That Detects SARS-CoV-2, Flu A, Flu B, and RSV in One Test

    • Abbott's Alinity m Resp-4-Plex assay will allow healthcare workers to test for four viruses in one test, a critically important tool as flu season emerges alongside COVID-19
    • The test helps save on much-needed testing supplies since it allows for testing for all four viruses with one swab
    • Assay will run on Abbott's most advanced molecular PCR platform, the Alinity m system, which provides fast results in high volumes

    ABBOTT PARK, IL., 15th December, 2020 – Abbott today announced CE Mark for the company's Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test. This is an important tool as flu season emerges alongside COVID-19 and because these viruses have similar symptoms but require different treatment approaches.

    The Alinity m Resp-4-Plex test can be conducted with one swab specimen (nasopharyngeal) collected by a healthcare provider from individuals with signs and symptoms of respiratory tract infection and will run on Abbott's Alinity m system—the company's most advanced high-volume laboratory molecular instrument. Alinity m uses Polymerase Chain Reaction (PCR) technology, which is known for its high sensitivity in detecting infectious diseases. To help fight the pandemic, Abbott has accelerated placements of the Alinity m system in hospital labs, academic centres and labs that are critical to patient care.

    "As healthcare workers on the frontline are seeing surges in COVID-19 cases in certain areas, they are now faced with the added influx that comes with seasonal flu," said Andrea Wainer, executive vice president, Rapid and Molecular Diagnostics, Abbott. "Abbott has been hyper focused on delivering COVID-19 tests in as many settings as possible and this newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care."

    Advanced technology's role in the fight
    The Alinity m Resp-4-Plex assay will be a critical tool in detecting these four prevalent respiratory viruses, especially as flu season and the COVID-19 pandemic merge. The advanced technology of the Alinity m system provides automation and on-demand access, meaning an urgent test can be run at any time. This flexibility and efficiency allow for the testing of multiple diseases while still producing fast results in high volumes. This assay's ability to detect these viruses simultaneously with only one swab will also ease the resource strain on collection devices, which have been in high demand throughout the COVID-19 pandemic.

    Since the start, Abbott has been developing and introducing tests that have been playing a critical role in fighting the pandemic. The need for a combination of testing methods in different settings has been clear. And now this new test will play a vital role as healthcare providers deal with the emergence of flu season.

    About Alinity m
    Assays previously CE marked to run on the Alinity m system include: HCV (hepatitis C), HBV (hepatitis B), HIV-1, SARS-CoV-2, sexual transmitted diseases (CT/NG/TV/MG) and high risk HPV. The easy-to-use system will help to improve laboratory workflow and efficiency with its large capacity and fast turnaround time, being able to run up to 1,080 tests in a 24-hour period based on laboratory practice and workflow. Alinity m systems are designed to be more efficient – running more tests in less time and minimizing human errors – while continuing to provide quality results. The availability of the Alinity m system and tests varies by geography. More information is available at

    About Abbott
    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

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