TEST:

ALINITY m HR HPV ASSAY

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.

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.

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, 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.

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.

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).

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.

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.

Alinity m HR HPV assay agreement using the clinical cutoff in ThinPrep was PPA ≥85.44% and NPA ≥95.35% and in SurePath PPA ≥84.00%, NPA ≥93.84%. The NGS genotyping agreement results from this study demonstrate that the Alinity m HR HPV assay with extended genotyping can be effectively included as part of a cervical cancer screening program.

In conclusion, clinical sensitivity of Alinity assay on all self-sample types was similar to cervical specimens in a colposcopy referral population. Adjustment of signal-thresholds improved assay´s accuracy to detect CIN2+ in all self-sample types.

"Abbott...has received U.S. Food and Drug Administration (FDA) approval for its molecular human papillomavirus or HPV screening solution, adding a powerful cancer screening tool for detecting high-risk HPV infections to the Alinity m family of diagnostic assays...The Alinity m high risk (HR) HPV assay is approved as a test for HPV detection and for use in routine cervical cancer screening as per professional medical guidelines."