Human papillomavirus (HPV) is the etiological agent for the development of cervical cancer and its precursor lesions (1): a persistent infection with high-risk (HR) HPV types has been established as a necessary step in the progression from precancerous to neoplastic disease (2). It is widely recognized that different HR HPV genotypes have different oncogenic potential, with genotype 16 being the most oncogenic of the cancer-causing HPV genotypes (3, 4).For decades, the test of choice for the detection of cervical intraepithelial neoplasia (CIN) was the Pap smear (5). However, the Pap test has severe limitations: a relatively low sensitivity for detection of disease (range, 51 to 74%, depending on the study), limited reproducibility, interobserver variability, and finally the occurrence of equivocal results (6). The advent of HPV testing has introduced an epochal change in cervical cancer screening: in recent years, we observed a gradual shift in the use of HPV test from a "triage test," in case of equivocal cytology, or as an adjunct test to cytology in women older than 30 years, to a primary screening test. This introduction of molecular HPV testing is slowly changing the premise of cervical screening, promising better performance than cytology-based screening but also posing new challenges (7). Over the last 7 years, HPV testing has gained a foothold in a number of national screening programs, most notably in triage of equivocal cytology or as an adjunct test to cytology in women older than 30 years, as well as more recently as a primary screening modality. Four European randomized control trials (RCTs), as recently summarized by Ronco and colleagues, clearly demonstrate the benefit of HPV testing over the use of the Pap smear (8). In this scenario, the performance of the HPV testing system of choice is crucial: the key is for an HPV assay to have an optimal balance between sensitivity and specificity for detection of CIN grade 2 or 3 (CIN2ϩ) lesions in order to identify virtually all women with immediate precursors or in rare cases cervical cancer, and at the same time not to result in too many screening false-positive samples (9, 10). The advantage of HPV testing relies on its high sensitivity, Ն95% for CIN2ϩ lesions, which translates into a high negative predictive value (NPV) allowing for extended screening intervals without increased risk of cervical cancer: HPV-negative women have a reduced risk for CIN2/3 lesions and cancer in the subsequent screening round as demonstrated by the European RCTs (8).Several in-house HPV DNA detection methods have been successfully used in research laboratories worldwide for more than 2 decades, and some have been employed for diagnostic purposes in countries where "nonapproved" tests for routine clinical testing are allowed (11). Recently, new tests using microarrays or real-time PCRs have been developed: the majority of them have been designed to

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.

Our results confirm that the cut-off value of 1 suggested by Qiagen for PreservCyt specimen is the best cut-off value also for self-sampled specimens.