About one out of two cervical cancers are diagnosed in women without a history of screening. High-risk HPV self-sampling (i.e. self-collection of cervico-vaginal specimen) may lower the screening barrier and enhance the effectiveness of the screening programme. The diagnostic accuracy of primary HPV testing on self-collected samples needs to be assessed.
In a randomized study, women participating in the Dutch cervical cancer screening programme are randomly allocated to either self-collection or collection by a clinician. HPV testing is carried out on the collected samples by the GP5+/6+-PCR method. HPV-positive women are cross-tested using the other HPV collection method. HPV positive women are triaged by cytology on the clinician-collected sample. The enrollment started in January 2015 and will be completed in November 2016. Primary endpoints are the clinical sensitivity and specificity of HPV self-sampling for detection of CIN2 or worse.
3,293 women were enrolled in year 2015 and about 9,500 women will be enrolled in 2016. High-risk HPV positivity rates of sampled collected in 2015 were 7.3% for HPV-self sampling and 8.0% for clinical-based sampling. Of 97 women with a positive HPV test and abnormal cytology, 84 scored positive on the HPV cross test.
These intermediate results are supportive of HPV self-sampling as self-collected and clinician-collected samples had similar proportion of positive HPV results. Reliable estimates of the clinical sensitivity can only be made after completion of enrolment.
This presentation is part of the CoheaHr session (SS07)