Human papilloma virus (HPV) comprises a group of about 100 viral strains of which about 20 are potentially infectious to humans. In particular, some types have been correlated with cervical cancer. The prevalence of this infection is very high in sexually active adults and increases with the number of sexual partners. HPV is responsible for more than 90% of cervical carcinomas, the most̀ frequent cancer in women after breast cancer (600,000 new cases per year are shown)1, 2.
HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 are classified as high-risk HPV. Cervical carcinoma can develop if there is persistent infection with these high-risk genotypes. HPV 16 and 18 are reported to cause 70% of cervical cancers worldwide, 15% of cases are related to HPV genotypes 31, 33, 35, 45, 52 and 58 while the remaining 15% of cases are related to rarer types1, 2.
Viral DNA detection and typing (HPV-DNA test) aims to detect the presence of the virus and, especially, those serotypes correlated with the development of cervical cancer. This makes it possible to identify women potentially at risk for cervical cancer.
The test is performed on biopsies or urogenital swabs, preferably dry, and can be performed to flank a PAP-test even during equivocal screening or clinical manifestations that need further diagnostic investigation. The test can also be offered to patients who have undergone HPV vaccination.
Hyris offers an innovative approach of validating and integrating on its platform the best CE-IVD kits from reagent manufacturers on the market.
For the HPV kit, Hyris selected the screening test with identification of the highest number of HPV strains on the market and with innovative features:
Detection of viral presence is performed by a Real-Time PCR assay that takes advantage of specific fluorescent probes in the two PCR tubes (PCR Master Mix 1 and 2).