Non-speculum clinician-taken samples for human papillomavirus 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.

Cervical screening: the evolving landscape

“… 13 Previously published in this journal, the same group explored uptake of non-speculum clinician sampling for those aged ≥50 years who were late for screening by ≥12 months. 14 Targeting this age group is deliberate and important as individuals aged >65 years account for around half of all cervical cancer deaths. 15 Those inadequately screened prior to exiting the NHS Cervical Screening Programme and/or with unknown hr-HPV status are most at risk, prompting some countries to extend the screening age to 75 years or offer a one-off ‘catch up’ hr-HPV test.…”

Recent advances in the cervical screening programme

“…Nonspeculum samples have a similar sensitivity for the detection of CIN2+ and are comparable with conventional samples for hrHPV. 18 Women aged 50-64 years with lapsed screening have increased uptake when offered non-speculum sampling, 19 helping to ensure that women are hrHPV negative on exiting the CSP.…”

“…The use of non‐speculum sampling, by self‐taken or clinician‐taken swabs or urine sample is particularly appealing to populations who find vaginal sampling unacceptable. Non‐speculum samples have a similar sensitivity for the detection of CIN2+ and are comparable with conventional samples for hrHPV 18 . Women aged 50–64 years with lapsed screening have increased uptake when offered non‐speculum sampling, 19 helping to ensure that women are hrHPV negative on exiting the CSP.…”

relationship between HPV positivity and abnormal cervical cytology changes with age in perimenopausal women

“…Although classification according to age at 30 years is definitely warranted when employing HPV DNA testing in screening, it is unclear if the suggestions for females above thirties are similarly true during the life span of a woman of screening. "Because the rate of pre-neoplastic disease is low (8), few studies of women over age 30 have the power to further stratify by age in order to better inform guidelines" (7)(8)(9)(10)(11) Women with all grades of "pathology-confirmed cervical intraepithelial neoplastic (CIN)" showed a reduction in HR-HPV identification with age, with the most pronounced decline seen for HPV 16 infection, according to a recent study from the ATHENA trial, that contained data on more than thirty five thousand women aged thirty and older. "In the HPV in Perimenopause (HIP) cohort of routinely screened women age 35-60 years, we observed a similar trend of decreasing correlation between HR-HPV detection and cervical abnormalities with increasing age" Our goal was to learn more about the relationship between agerelated aberrant cytology and either HPV and HR-HPV detection (12)(13)(14).…”