CoCoss-trial: Concurrent comparison of self-sampling devices for HPV-detection

Purpose The new German screening program for cervical carcinoma starting 2020 includes a co-testing of cytology and hr-HPV testing every three years. Participation rate has been around 70 % before. Non-participators are proven to be at higher risk to develop cervical carcinoma. To increase the participation rate self-sampling devices for home-collection of cervicovaginal material for HPV testing were developed. This study was designed to compare two dry vaginal self-sampling devices (FLOQSwabs, COPAN, Italy; Evalyn Brush, Rovers Medical Devices, the Netherlands) and a self-collection device for first-void urine (Colli-Pee, Novosanis, Wijnegem, Belgium) to a physician-taken HPV sample.

Material and methods Approximately 60 women older than 20 years will be recruited over a planned period of 6 months at two colposcopy clinics. All participants will use the three self-sampling devices and will also have a clinician-taken reference smear. Colposcopy always will and biopsy might be performed in case of suspicious clinical findings. HPV is tested with the Abbott RealTime High Risk HPV Test.

Results Primary objectives will be the clinical performance (detection of high-grade CIN) of all three self-sampling devices using the clinical smear as gold standard:

• Sensitivity (non-inferiority testing)

• Specificity

Secondary objectives:

• Analytical performance of the self-sampling devices using the clinical smear as gold standard:

Correlation of HPV positivity

• Evaluation of user-friendliness and comfort/discomfort by the participants (questionnaire)

Conclusion To raise the participation rate among non-responders to the screening program, purpose of this prospective study is to evaluate and compare the clinical effectiveness and performance of three different self-sampling devices.

Publication History

Article published online:
07 October 2020