Description
This test (CE-IVD) allows the qualitative multiplex detection of 15 HPV with high carcinogenic risk by qPCR from purified genital (cervical, vaginal, vulvar, urethral, anal) and urine samples. The analysis is carried out in two reactions, discriminating two groups of genotypes G1 (31, 33, 52, 58) and G2 (35, 39, 51, 56, 59, 66, 68, 82) and allowing the specific identification of genotypes 16, 18 and 45.
The test is designed for the specific detection of 15 HR-HPV using different sets of primers and probes targeting the E6 and E7 oncogene regions, greatly reducing the risk of false negative results due to aberrant viral integration. An additional primer and probe set to detect a human gene is also used to monitor the presence of PCR inhibitors in the clinical sample and to assess sample quality and DNA extraction.