Non-speculum clinician-taken samples for human papillomavirus testing: a cross-sectional study in older women

Background Cervical cancer incidence and mortality are high in women aged >= 65 years. despite the disease being preventable by screening. Speculum based screening can become more uncomfortable after the menopause. Aim To examine test performance and acceptability of human papillomavirus (HPV) testing on clinician-collected vaginal samples without a speculum (non-speculum). Design and setting Cross-sectional study in 11 GP practices and four colposcopy clinics in London, UK. between August 2017 and January 2019. Method Non-speculum and conventional (speculum) samples were collected from women aged >= 50 years attending fora colposcopy (following a speculum HPV-positive screening result) or women aged >= 35 years (with confirmed cervical intraepithelial neoplasia (CIN) 2+), and women aged 50-64 years attending routine screening. Sensitivity to CIN2+ was assessed among women with confirmed CIN2+ (colposcopy). Specificity to HPV relative to speculum sampling and overall concordance was assessed among women with negative cytology (routine screening). Results The sensitivity of non-speculum sampling for detecting CIN2+ was $3.3% (95% confidence interval (CI) = 60.8 to 94.2) = 15/18). There was complete concordance among women with positive CIN2+ who had a speculum sample <= 91 days prior to the non-speculum sample [n = 12). Among 204 women with negative cytology, the specificity to HPV was 96.4% (95% CI = 92.7 to 98.5) with 96.6% concordant results (k 72.4%). Seventy-one percent (n= 120/170) of women preferred a non-speculum sample for their next screen. Conclusion HPV testing on non-speculum clinician-lakes samples is a viable approach that warrants further exploration in larger studies. Overall test performance was broadly comparable with that of self sampling.

Automated summary

Testing for HPV using clinician-collected vaginal samples without a speculum is a viable and comfortable alternative to speculum-based screening, with comparable results to self-sampling.