Validation of the dry Evalyn Brush, an improved cervicovaginal self-sampling device for HPV detection

Primary screening on high-risk Human papillomavirus (hrHPV) will be the next
step in prevention of cervical cancer. Women not attending screening are more
likely to participate given the opportunity of self-sampling for hrHPV testing.
The Evalyn Brush (Rovers, The Netherlands) is an improved user friendly and
easy to use cervicovaginal self-sampling device which is developed according to
user requirements of women. Before the Evalyn Brush may be used in cervical
cancer screening, this self-sampling device has to be validated in a screening
population.

This study will be conducted to determine the overall hr-HPV agreement between
self-sampled cervicovaginal smear (Evalyn Brush) and physician-obtained samples
taken by a trained physician (liquid based cervical smear) in a screening
population. The acceptability of using this self-test will be determined.

We will recruit women visiting the general practitioner for a regular cervical
smear. All participants will meet the criteria for the national screening
program for cervical cancer in the Netherlands. They are informed about the
study by the general practitioner or the practice assistant. After informed
consent the participating women takes, before the regular cervical smear, an
Evalyn Brush self-test by following the enclosed instructions. After
self-sampling, a trained physician obtained a regular cervical smear suspended
in ThinPrep medium. The quality of the regular cervical smear will not be
influenced by self-sampling with the Evalyn Brush.

All women are asked to self-collect a cervicovaginal sample with the Evalyn
Brush for determination of HPV before the regular cervical smear.

All participating women should self-collect one additional cervicovaginal
self-sample. The risk and burden of the participating women is negligible.
Performing a vaginal smear themselves implies no danger for their own health
whatsoever. After the examination, all participating women are requested to
fill out a short self-administered questionnaire, containing questions on
acceptability of using the self-test.