Mortality for cervical cancer varies between the different regions of the world, with high rates in under developed countries where screening programs are not present and organized. However increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device, and on the clinical performance of the high-risk HPV test.
This study based on 786 women scheduled for cervical cytology for any reason or for a cervical conservative treatment for CIN at European Institute of Oncology, investigates the best cut-off value of HC2 (Qiagen, Hilden, Germany) test, a signal amplification detection system based on chemiluminescence that detects 13 HR-HPV, for self-sampled specimens ( Qiagen Hybrid Capture (HC) Cervical Sampler) in terms of sensitivity and specificity.
In our population we found that the sensitivity and the specificity for cervical intraepithelial neoplasia grade 2 or more (CIN2+) detection of HC2 performed on self-sampled specimens were 82.5% and 82.8% respectively, considering the relative light units (RLU) cut-off of 1.Increasing the cut-off value the sensitivity decreases and the specificity raises and the best AUC for the RLU cut-off is 1.
Our results confirms that the 1 cut-off suggested by Qiagen for PreservCyt specimen is the best cut-off also for self-sampled specimens.