Achieving high uptake of cervical screening is key to the WHO’s strategy for elimination of cervical cancer as a public health problem. Within the EU, a substantial proportion of the cervical screening target population do not avail of screening, mainly due to social, practical, and emotional barriers (2). The use of self-sampling for HPV-based cervical screening is a feasible and accepted approach, with substantial evidence demonstrating that self-sampling can improve population uptake of cervical screening (3). One of the key challenges with HPV testing is the poor specificity of the test and the need for more accurate triage tests to improve the specificity of HPV-based primary screening (4). One such approach already demonstrated to have higher specificity than HPV testing alone includes testing for the presence of two cellular proteins, p16INK4a and Ki-67 (CINtec PLUS assay) (5). However, there is limited data on the performance of CINtec PLUS in self-collected cervical samples. This project will assess whether CINtec PLUS can be used on self-collected cervico-vaginal samples with the potential to be used as a triage test on women who test positive for hr-HPV to help differentiate women who require further investigations. We hypothesise that dual staining for p16INK4a and Ki-67 biomarkers on self-collected cervical samples is comparable to clinician-collected samples. The objectives of the project are to assess the adequacy of cytology from self-collected cervical samples compared to clinician-collected samples and to immunostain for CINTec PLUS (p16INK4a/Ki-67) on hr-HPV positive self-collected and matched clinician-collected samples. Lastly, an analysis will be carried out on the performance of CINtec PLUS on self-collected cervical samples compared to clinician-collected samples for detecting high-grade disease. Our findings will provide clinically relevant data, contributing to the body of evidence around the use of self-collected samples for HPV-based screening and downstream triage.
