Testing of a new probe 16/18/45 Hybrid Capture (Digene) in women with high risk HPV infection

BACKGROUND: HPV HR detection test are needed when ASCUS is diagnosed on Pap test. The risk of progression to cervical cancer is dependant on the HPV genotype and three types (HPV 16, 18 and 45) are found in 77.4% of the cervical cancer. Here we have tested a new probe 16/18/45 (Digene) that is able to detect specifically these three types. MATERIAL AND METHODS: Thirty-seven women with a Hybrid Capture 2 High Risk test (Digene) positive were selected to test the new probe 16/18/45. Samples were typed using sequencing reaction after GP5+/GP6+ PCR. Types were given after comparison with the GenBank. Discordant results were controlled with Inno-Lipa HPV genotyping v2 test (Innogenetics). RESULTS: Among the 37 women with HR HPV result, 48.6% were positive with the probe 16/18/45 (18 patients). After genotyping, 12 results were concordant and six discordant (three HPV 31, two HPV 58 et one HPV 59). For the other 19 patients with negative result, 18 are concordant and one discordant (HPV 18). Global concordance for typing between this probe and sequencing was 81% with a kappa test of 0.62 that means a good concordance. Positive predictive value is 66.6% and negative predictive value is 94.7%. CONCLUSION: This study shows a good efficiency of the 16/18/45 probe to detect the genotypes that have the higher risk of progression to cervical cancer. This probe could also allow to follow the epidemiology of HR HPV infection after a large use of HPV vaccines.