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

TY - JOUR

T1 - Non-speculum clinician-taken samples for human papillomavirus testing

T2 - a cross-sectional study in older women

AU - Landy, Rebecca

AU - Hollingworth, Tony

AU - Waller, Jo

AU - Marlow, Laura Av

AU - Rigney, Jane

AU - Round, Thomas

AU - Sasieni, Peter D

AU - Lim, Anita Ww

N1 - Funding Information: This work was supported by funding from Cancer Research UK (reference: C16499/ A21716) that was awarded to Anita WW Lim. Anita WW Lim and Jane Rigney are supported by Cancer Research UK grants (references: C8162/A16892 and C8162/ A27047) awarded to Peter D Sasieni. Jo Waller and Laura AV Marlow are supported by a Cancer Research UK career development fellowship (reference: C7492/A17219) awarded to Jo Waller. Rebecca Landy is supported by the Intramural Research Program of the US National Institutes of Health/National Cancer Institute. Thomas Round is supported by a National Institute for Health Research Doctoral Research Fellowship (reference: DRF-2016-09-054) and was previously supported by a Royal Marsden Partners Research Fellowship. The study sponsors were King’s College London and Queen Mary University of London. The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. Publisher Copyright: © The Authors.

PY - 2022/8/1

Y1 - 2022/8/1

N2 - 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 for a 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 83.3% (95% confidence interval [CI] = 60.8 to 94.2) (n = 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 (κ 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-taken samples is a viable approach that warrants further exploration in larger studies. Overall test performance was broadly comparable with that of self-sampling.

AB - 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 for a 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 83.3% (95% confidence interval [CI] = 60.8 to 94.2) (n = 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 (κ 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-taken samples is a viable approach that warrants further exploration in larger studies. Overall test performance was broadly comparable with that of self-sampling.

UR - http://www.scopus.com/inward/record.url?scp=85135370043&partnerID=8YFLogxK

U2 - 10.3399/BJGP.2021.0708

DO - 10.3399/BJGP.2021.0708

M3 - Article

C2 - 35667684

SN - 0960-1643

VL - 72

SP - e538-e545

JO - The British journal of general practice : the journal of the Royal College of General Practitioners

JF - The British journal of general practice : the journal of the Royal College of General Practitioners

IS - 721

ER -