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    6ms
    Clinical accuracy of Alinity m HR HPV assay on self- versus clinician-taken samples using the VALHUDES protocol. (PubMed, J Mol Diagn)
    In conclusion, clinical sensitivity of Alinity assay on all self-sample types was similar to cervical specimens in a colposcopy referral population. Adjustment of signal-thresholds improved assay´s accuracy to detect CIN2+ in all self-sample types.
    Journal
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    ALINITY m HR HPV ASSAY
    6ms
    Abbott receives FDA approval for HPV test to run on Alinity m, offering primary HPV screening and assessment of high-risk cancer-causing types of HPV (PRNewswire)
    "Abbott...has received U.S. Food and Drug Administration (FDA) approval for its molecular human papillomavirus or HPV screening solution, adding a powerful cancer screening tool for detecting high-risk HPV infections to the Alinity m family of diagnostic assays...The Alinity m high risk (HR) HPV assay is approved as a test for HPV detection and for use in routine cervical cancer screening as per professional medical guidelines."
    FDA event
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    ALINITY m HR HPV ASSAY