Resumen
The advances in cervical cancer screening have mostly focused on high-risk human papillomavirus (HR HPV) detection as the primary screening tool in women over 30 years old. Although many new HPV assays have been commercialized during the last few years, only a few of them are validated according to international guidelines. Recently, new approaches for genotype-based risk-stratification and triage of HPV positive women have been developed. In this study, the Vitro HPV Screening assay targeting 14 oncogenic genotypes (HPV16, HPV18, and another 12 HR HPV genotypes) has demonstrated an appropriate clinical performance to be used as primary screening test. Additionally, the 12 HR HPV genotypes have been individually genotyped with a complementary assay performed by reverse dot blot hybridization of the PCR product from the HPV Screening assay. In conclusion, this new assay represents a unique integrated solution for cervical cancer screening with the extended HPV genotyping as a clinical tool for risk determination.