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.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 be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV genotype.The results of this test are not intended to prevent women from proceeding to colposcopy. 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 Alinity m HR HPV assay is intended for the following uses: 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 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. Built in cellular control provides diagnostic confidence in negative results by ensuring sample adequacy, which in turn helps guide patient management.Multiplex detection of 14 high risk genotypes for the general and vaccinated population by enabling clinical practice for the future through next level risk stratification.Integrated evidence based risk stratification by separately reporting HPV genotypes 16, 18, 45 and two pools of HR HPV genotypes in ONE single reaction.Alinity m high risk HPV assay delivers timely and clinically relevant information on 14 high risk HPV genotypes which combined with uniquely matched outstanding workflow efficiency while meeting the needs of the clinicians and laboratories.
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