The digene HPV Genotyping PS Test is an in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of the 3 high-risk types of HPV DNA in cervical specimens. The assay is intended as a reflex test to a positive digene HC2 High-Risk HPV DNA Test result, to determine the presence or absence of 16, 18, or 45 genotypes.
HPV types 16, 18, and 45 are the most commonly found high-risk HPV types associated with squamous cell carcinoma and adenocarcinoma. A recent study of HPV genotypes shows that invasive cervical cancers which are related to HPV types 16, 18, and 45 are diagnosed on average 4 years earlier than cervical cancers associated with other high-risk HPV types. (de Sanjose, S. et al. (2010) Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet 11, 1048.)
Samples collected with the digene Cervical Sampler may be used with the digene HPV Genotyping PS Test.