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Published on: March 8, 2012
Alinity m HR HPV Assay: United States Clinical Trial Design and High-Risk Human Papillomavirus Prevalence
Mark Stoler1, Richard Cullum2, Danijela Lucic2
1Professor Emeritus of Pathology and Clinical Gynecology, University of Virginia Health, Charlottesville, VA.
Objective:
The Alinity m HR HPV assay is a qualitative molecular assay that simultaneously detects high-risk human papillomavirus (hr HPV) genotypes HPV16, 18, and 45 and reports the 11 other hr HPV genotypes in 2 aggregates as other HR HPV A (HPV31, 33, 52, 58) and other HR HPV B (HPV35, 39, 51, 56, 59, 66, 68). Here, the authors describe the prevalence of hr HPV genotypes in the Alinity m HR HPV assay US clinical trial population stratified by age, cytology, and cervical disease status.
Methods:
This study included 11,532 women undergoing routine cervical cancer screening.
Results:
Overall hr HPV positivity decreased with age. Other HR HPV B genotypes had the highest positivity followed by other HR HPV A, HPV16, HPV45, and HPV18. In the population with ≥atypical squamous cells of undetermined significance cytology, other HR HPV A and other HR HPV B genotypes had the highest positivity rates. HPV16 and other HR HPV A positivity rates were highest in specimens with ≥cervical intraepithelial neoplasia 3 by histology.
Conclusions:
This analysis of primary screening participants in the Alinity m HR HPV assay US clinical trial demonstrates the benefits of including genotype-specific testing in cervical cancer screening programs.
