New approach for hrHPV population screening for cervical cancer

HPV-based testing in women of screening age is essential to decrease the probability of developing cervical cancer. This screening program has been carried out opportunistically in Spain using conventional cytology for 50 years. In 2019 the National Health System has modified this program (Order SCB/480/2019), establishing an organized population-based screening that would be implemented gradually and incorporating the HPV-based testing as a primary screening test in part of the target population. Recent European guidelines also strongly recommend primary HPV-based screening over standard cytology-based screening. In addition, HPV-based screening offers the possibility of self-sampling. The success of a cervical cancer screening program depends largely on the participation of the population under study. An effort to increase participation in the screening of women of difficult access can substantially reduce this risk. Several barriers have been identified. The self-sampling by women is an option to reduce part of these barriers. Various studies have observed high acceptability and positive attitudes towards self-sampling, without differences in preferences based on age, education, and marital status; they also showed their predilection for this type of samples in future visits. The possibility of having a self-sampling system offers an agile and effective solution in the primary screening program for cervical cancer based on HPV study.

There are different kits available on the market for the detection of HPV in the context of cervical cancer screening. In 2009¹ an international committee of experts proposed certain criteria to denote trials suitable to determine the ability of a test to be used for the detection of cervical cancer. These criteria have the objective to ensure that candidate assays must have an ideal balance between the clinical specificity and sensitivity for the detection of CIN2/3, which reduces the number of follow-up tests a woman must undergo. In addition, each new test must be highly reproducible.

Vitro, S.A. (Granada, Spain) presents its HPV 360 solution for the correct detection of the different genotypes of the human papilloma virus, which includes a continuous process with complete traceability from start to finish: a self-sampling kit (AURA) that easily and safely allows the collection of the sample, a completely automated DNA extraction from the primary samples, HPV screening for genotypes with high oncogenic risk using the real-time PCR technique, and genotyping from the amplified product. This solution allows individualized and complete genotyping of all positive screening samples.

In this symposium we will present the validation of the HPV Screening Real Time PCR detection technique (Vitro S.A.) as a primary screening test for cervical cancer following the recommendations published by Meijers et al¹. This study would be presented by one of centers participating in the study: The Unit of Pathological Anatomy from Hospital del Mar (Barcelona), that has performed the study in collaboration with the Catalan Institute of Oncology (ICO-IDIBELL, Barcelona). We will also present an innovative and easy to use self-sampling kit (AURA, Vitro S.A.) and two clinical studies being performed to investigate the relative sensitivity and accuracy of hr-HPV DNA detection in self-collected samples using Vitro’s device compared with traditional physician-collected liquid-phase cytology. These studies were performed in primary care services and in gynaecology services of the public health system pf Spain.