Abbott Alinity m HR HPV AMP

The Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System to detect DNA of high-risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. It specifically identifies HPV 16, 18, and 45 while reporting concurrent detection of HPV (31/ 33/ 52/ 58) and HPV (35/ 39/ 51/ 56/ 59/ 66/ 68) at clinically relevant infection levels. The assay is intended for: • Screening patients with ASC-US cervical cytology test results to determine the need for referral to colposcopy. • Used with cervical cytology to adjunctively screen to assess the presence of high-risk HPV. • As a first-line primary screening test to identify women at increased risk for cervical cancer development or presence of high-grade disease. • To assess the presence of HPV 16 and 18 to identify women at increased risk for cervical cancer development or presence of high-grade disease with or without cervical cytology