TEST:

ALINITY m HR HPV ASSAY

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.

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."