Work

Clinical Performance of the Alinity m HR HPV Assay in a Large Urban Cervical Cancer Screening Program in the United States

Year: 2025

Type: article

Abstract: Background Certain high-risk human papillomavirus (HR HPV) genotypes may carry greater risk of progression to high-grade cervical cancer, and extended HR HPV genotyping may help refine risk assessment. Objectives To examine the performance of the Alinity m HR HPV assay in comparison to cobas 4800 HPV assay (cobas 4800) and the association between cytology results, age, and extended HR HPV genotyping. Study design This was a cross-sectional cohort study of 149 de-identified remnant cervical cytology specimens collected in ThinPrep as part of a routine cervical cancer screening program at a large urban hospital system. Specimens were tested on the Alinity m HR HPV assay and the cobas 4800 assay; results were analyzed by age and cytology. Results Overall percent agreement (OPA) between Alinity m and the cobas 4800 assay was >96% for the detection of any HR HPV, HPV 16 and 18, and other HR HPV genotypes, across all cytology categories (Cohen’s κ ≥0.91). The majority of Alinity m negative results had negative for intraepithelial lesions or malignancy (NILM) or atypical squamous cells of undetermined significance (ASC-US) cytology. Alinity m positivity, particularly for HPV 16, 18, and Other A (HPV 31, 33, 52, and 58), increased with the severity of atypical cytology. Alinity m positivity was more often associated with ASC-US cytology in specimens from individuals ≤29 years of age and with low-grade squamous intraepithelial lesion (LSIL) cytology or more severe cervical disease in individuals ≥30 years of age. Conclusions The extended genotyping capability of the Alinity m HR HPV assay may aid in the detection of specimens with increased risk of progressing to high-grade cervical disease.

Source: Journal of Gynecology and Womens Health

DOI: 10.19080/jgwh.2025.27.556211