Use of HC2 to triage women with borderline and mild dyskaryosis in the UK

To investigate the feasibility and efficiency of a nationwide rollout of human papillomavirus (HPV)-based triage for cervical cytology results of borderline (BD) or mild dyskaryosis (MD) in the UK, a study at six sentinel sites including more than 10 000 women aged 25–64 was conducted in a real life setting ( Kelly et al, 2011 ). The applied triage test was the Hybrid Capture-2 assay (HC2, Qiagen, GmbH, Hilden, Germany), which detects DNA of 13 high-risk (hr) HPV types. The cut-off chosen for a positive HPV test was ⩾ 2 RLU/PC (relative light units/positive control), which is lower than what was used in a previous pilot study ( ⩾ 3 RLU/PC), but higher than what is widely used in Europe and the US ( ⩾ 1 RLU/PC). All HPV-positive women were referred for colposcopy involving biopsies from visually abnormal areas of the cervical epithelium. HPV-negative women and HPV-positive women with negative colposcopy or histology findings were returned to the usual screening schedule. A histological result of CIN1 (cervical intraepithelial neoplasia of grade 1) resulted in a follow-up cytology 12 months later, whereas CIN2 or worse lesions (CIN2+) were treated. Outcomes were the referral rate to colposcopy (or rate of HPV-positivity) and the yield of underlying CIN2+ or CIN3+ among referred women (positive predictive value (PPV)). To evaluate the heterogeneity of HPV prevalence and PPV for cervical disease, several covariates were addressed, including age of the woman, type of liquid-cytology (SurePath (BD, TriPath Imaging inc., Burlington, NC, USA) or ThinPrep (Hologic Inc., Marlborough, MA, USA)) and laboratory site.