The Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System for the detection of DNA from 14 high-risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotypes (31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68) at clinically relevant infection levels. The Alinity m HR HPV assay is intended for the following uses:
- To screen patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy.
- To be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV genotype.
- To be used as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease.
- To assess the presence or absence of HPV genotypes 16 and 18 to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease with or without cervical cytology.
The results from the Alinity m HR HPV, together with the physician’s assessment of cytology, history, other risk factors, and professional guidelines, may be used to guide patient management.