AUG 18, 2020 6:00 AM PDT

Clinical validation of the Alinity m HR HPV assay

Speaker
  • Analyst in Laboratory Biomedicine, Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Slovenia
    BIOGRAPHY

Abstract

DATE:  August 18, 2020

TIME:   6:00am PDT, 9:00am EDT

 

More than 250 HPV tests and hundreds of different variants are commercially available globally, but majority of these tests do not meet the performance characteristic standards agreed upon in the HPV community or have analytical or clinical evaluation data published in peer reviewed journals. HPV test performance can be determined in multiple different ways, but the most widely adopted guideline is the 2009 international consensus on minimal requirements that HPV tests needs to meet so they can be safely used in clinical practice. Besides these, VALGENT, initiated in 2012, provides a formalized and uniform study framework that enables comparison and validation of HPV assays with genotyping capability. Alinity m HR HPV assay is the 14th assay that has been evaluated using the VALGENT-3 framework. Within the study, risk stratification using Alinity m HR HPV assay was determined as well. 

 

Learning Objectives:

  • Understand how Alinity m meets the 2009 international consensus guidelines on test requirements for primary cervical cancer screening
  • Demonstrate performance characteristics of Alinity m HR HPV assay in the VALGENT-3 framework
  • Assess the importance of extended genotyping to evaluate risk and triage patients effectively

 

 

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