TEST:

ALINITY m HR HPV ASSAY

There was a strong test concordance between self-collected and clinician-collected samples using the Alinity m HR HPV assay. Self-collected samples tested with the Alinity m HR HPV assays can be considered an alternative to clinician-collected primary HPV testing.

In women aged 20 to 24 with 40% uptake of quadrivalent HPV vaccine, overall HPV prevalence dropped from 25.3% to 12.8% (p < 0.001)... The first large-scale, systematic, and methodologically consistent study of HPV vaccine effectiveness in CEE showed a substantial reduction in high-risk HPV prevalence after implementation of the national program, with the greatest decline among women aged 20 to 24, who harbored the highest HPV burden in the pre-vaccination era. These locally acquired data will considerably inform public health strategies on cervical cancer elimination in CEE.

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.

Using the HPV test's adjusted cutoff for first-void urine, no difference in clinical sensitivity or specificity was observed between first-void urine and cervical samples. These data highlight the importance of evaluating self-sample-specific cut-offs for HPV assays, previously validated on cervical samples.

Extended HR HPV testing can provide additional information to triage patients for appropriate testing and follow-up.IMPORTANCEExtended genotyping for high-risk human papillomavirus (HPV) types enhances diagnostic precision by identifying additional oncogenic HPV types beyond 16 and 18 therefore offering a more nuanced risk profile. This more comprehensive detection may aid in identifying persistent infections that are more likely to progress, thereby supporting future risk-based patient management strategies.

In this study, HPV18 demonstrated the highest median difference between ≥CIN3 and ≤CIN1 (3.82 CN), followed by HPV16 (2.96 CN), Group A (2.53 CN), HPV 45 (2.23 CN), and Group B (2.09 CN).

In this study, analytical and clinical studies demonstrate that self-collected vaginal specimens can be utilized for routine cervical cancer screening with the Alinity m HR HPV assay.

These data demonstrate the differences in HR HPV genotype prevalence for the African American population compared to the total study population in a large U.S. clinical study. Despite the differences in genotype distribution, the Alinity m HR HPV assay demonstrated 100.0% (95% CI, 74.1%, 100.0%) sensitivity for African American women with cervical precancer and cancer.

In the Screening population, Group A HPV52 and Group B HPV68 had the highest prevalence among the sequenced samples. In the Enriched population, Group A HPV52 again had the highest prevalence, whereas HPV56 had the highest prevalence in the Group B.

Due to variable HPV vaccination uptake rates, HPV molecular tests used for cervical cancer screening must be able to detect cervical dysplasia regardless of vaccine status. These data demonstrate that the clinical sensitivity of the Alinity m HR HPV assay for the detection of cervical dysplasia is equivalent to the cobas HPV test in both vaccinated and unvaccinated populations.

In this study HPV16 and HPV18 carried the highest absolute risk followed by HPV45, Other A and Other B. These results indicate that the Alinity m HR HPV assay can effectively predict elevated risk for CIN3 or higher pathology in women 25 years or older. Our findings demonstrate the utility of the Alinity m HR HPV assay in routine cervical cancer screening.

The Alinity m HR HPV assay demonstrated an OPA of ≥90.3% when compared to the cobas 4800 HPV test across all HR HPV genotypes and cervical cytology grades for cervical specimens collected in SurePath.