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Background: High-risk (HR) Human Papilloma Virus (HPV) Tests for HPV detection differ in sensitivity and specificity. In this study, we evaluated the sensitivity and specificity of the HC2 HR HPV Test and the Cobas 4800 HPV Test in consecutive cervical samples collected from a referral population with a high prevalence of disease, using CIN2+ histology as clinical outcome. Methods: Ten thousand two-hundred and thirteen consecutive cervical samples were assayed for HR-HPV in the Laboratory Medicine Division of IEO: 5140 from January 2012 to June 2013 with HC2 and 5073 from July 2013 to December 2014 with the Cobas HPV Test. These two assays differ in terms of target genes and testing methods. Results: The test positivity rates for HC2 and Cobas 4800 were 29.5% (1515/5135, 95% CI 28.3–30.8%) and 23.9% (1212/5069, 95% CI 22.7–25.1%), respectively. The detection rates of CIN2+ in the two time periods were 2.8% (145/5140, 95% CI 2.4–3.3%) and 1.6% (79/5073, 95% CI 1.2–1.9%), respectively. The sensitivity for CIN2+ for HC2 and Cobas 4800 was 95.2% (138/145, 95% CI 91.7–98.7%) and 93.7% (74/79, 95% CI 88.3–99.0%), respectively. The specificity for CIN2+ for HC2 and Cobas 4800 was 72.4% (3613/4990, 95% CI 71.2–73.6%) and 77.2% (3852/4990, 95% CI 76.0–78.4%), respectively. There were 23 cases of cancer in each of the two time periods. HC2 detected 100% (23/23). Cobas 4800 detected 82.6% (19/23). Conclusions: The detection rate of CIN2+ was higher in the first period than in the second period. There was no significant difference in sensitivity of HC2 and Cobas 4800 in women with CIN2+. The specificity of CIN2+ using Cobas 4800 in the second period was higher than HC2 in the first period, probably due to the lower prevalence of CIN2+ in the second period

Objectives Little is known about the epidemiology of human papillomavirus (HPV) in Italy before the age of 25. At the European Institute of Oncology, a prospective observational study on cervical HPV infection in 18-year-old women undergoing quadrivalent HPV vaccination is ongoing. Methods At the first visit before vaccination, all the young women answered an epidemiological questionnaire, and then, the presence of high-risk HPV (hrHPV) was tested. Samples positive for hrHPV were genotyped. Liquid-based cytology was done only to women declaring not to be virgins. Any positivity at cytology or HPV testing was completed with colposcopy and eventually biopsies. Results Seven hundred and thirty women were enrolled. Two hundred sixty-six women were virgins; 7 (2.6%) of these resulted positive to hrHPV: 1 had HPV16 and CP6108, whereas the other 6 resulted negative at genotyping. Of the 464 nonvirgins, 61 (13.1%) were HPV positive: 19 had HPV16, 4 were positive to HPV18 with other hrHPVs, 25 to other hrHPVs, 7 to low-risk HPV, whereas 13 resulted negative at genotyping. HPV positivity was significantly associated to both smoking and having more than 3 partners. Cervical cytology was negative in 433 cases (93.3%), ASC-US in 10 cases (2.2%), low-grade squamous intraepithelial lesion in 20 cases (4.3%), and ASC-H in 1 case (0.2%). No CIN2+ was identified. Conclusions Overall, we found a low positivity to HPV in this population; however, the rate of HPV positivity was significantly related to smoking and sexual life. The cytology result low-grade squamous intraepithelial lesion was more frequent than in the screening population, whereas no CIN2+ was identified, confirming the indication to avoid screening at this age.

Objective To evaluate, from a gynecology perspective, the transition from cytology-based HPV screening to primary HPV screening. Method Studies examining switching from cytology-based screening to primary HPV-DNA testing with triaging of patients with positive test results were retrieved and reviewed, with a particular focus on screening in an Italian setting. Results The increased complexity of patient-management decisions when implementing HPV-based screening was a critical issue discussed in the literature. The change in strategy represents a paradigm shift in moving from a medical perspective of identifying the disease in individual patients, to a public-healthcare perspective of excluding HPV from the healthy population and identifying a small sub-group of individuals at increased risk of HPV. Conclusion With knowledge about HPV screening evolving rapidly, new programs and related algorithms need to be sufficiently flexible to be adjusted according to ongoing research and the validation of new assays. The establishment of a national working group (including epidemiologists, gynecologists, pathologists, and healthcare providers) will be necessary to properly implement and govern this important technical and cultural transition. This article is protected by copyright. All rights reserved.

Purpose: This study investigated the prevalence of Chlamydia trachomatis infection, co-infection with Human Papillomavirus (HPV) and associated risk factors in a cohort of sexually active young women enrolled in an ongoing trial on HPV vaccination at the European Institute of Oncology (IEO, Milan, Italy). Methods: Cervical samples were collected from 591 girls (median age 18.8 years) at the beginning of their sexual activity. At the time of sample collection, 354 women had not yet been vaccinated, and 237 women had been vaccinated for at least 12 months. All samples were analyzed through a molecular assay for the detection of C. trachomatis infection. Demographic, behavioral risk factors and high-risk HPV (HR-HPV) status were investigated. Results: The prevalence of C. trachomatis infection was 4.9 % and HPV/C. trachomatis co-infection rate was 1.5 %. The exact analysis has not underlined statistical significance for the variables considered, except for the infection with HR-HPV (p