Alinity m HR HPV Assay: United States Clinical Trial Design and High-Risk Human Papillomavirus Prevalence

Abstract

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.