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

Abstract

Background: Cervical cancer incidence and mortality are high in women aged 65 and above, despite being preventable by screening. Speculum-based screening can become more uncomfortable after the menopause. Aims: To examine test performance and acceptability of HPV testing on clinician-collected vaginal samples without a speculum (non-speculum). Design and Setting: Cross-sectional study in 11 GP practices and 4 colposcopy clinics in London, UK, August 2017–January 2019. Methods: Non-speculum and conventional (speculum) samples were collected from women attending colposcopy aged ≥50 (following a speculum HPV-positive screening result) or aged ≥35 (with confirmed CIN2+) and women aged 50-64 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 cytology-negative women (routine screening). Results: The sensitivity of non-speculum sampling for detecting CIN2+ was 83.3% (95% CI: 58.6-96.4%) (N=15/18). There was complete concordance among CIN2+ women who had a speculum sample within 91 days prior to the non-speculum sample (N=12). Among 204 cytology-negative women, the specificity to HPV was 96.4% (95% CI: 92.7-98.5%), with 96.6% concordant results (Cohen’s kappa=72.4%). Most women (77.8%, 133/171) preferred the experience of non-speculum sampling over conventional screening, with two-thirds preferring a non-speculum sample for their next screen (65.9%, 120/170). Conclusion: HPV testing on non-speculum clinician-taken samples is a viable approach which warrants further exploration in larger studies. Non-speculum samples had excellent concordance with speculum (conventionally-taken) samples for detecting HPV, with overall test performance broadly comparable to that of self-sampling.