When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples.
Marc Arbyn, coordinator1, Sara B Smith, project coordinator2, Sarah Temin, senior guidelines specialist3, Farhana Sultana, research fellow and epidemiologist4 5, Philip Castle, chief executive officer and professor2 6 on behalf of the Collaboration on Self-Sampling and HPV Testing.
1Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, J Wytsmanstreet 14, B1050 Brussels, Belgium2Global Coalition Against Cervical Cancer, Durham, NC, USA 3Department of Cancer Policy and Advocacy, American Society of Clinical Oncology, Alexandria, VA, USA 4Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia 5Registries and Research, Victorian Cytology Service Registries, Victorian Cytology Service Ltd, Carlton South, Australia 6Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA
Objective To evaluate the diagnostic accuracy of high-risk human papillomavirus (hrHPV) assays on self samples and the efficacy of self sampling strategies to reach underscreened women.
Design Updated meta-analysis.
Data sources Medline (PubMed), Embase, and CENTRAL from 1 January 2013 to 15 April 2018 (accuracy review), and 1 January 2014 to 15 April 2018 (participation review).
Review methods Accuracy review: hrHPV assay on a vaginal self sample and a clinician sample; and verification of the presence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by colposcopy and biopsy in all enrolled women or in women with positive tests. Participation review: study population included women who were irregularly or never screened; women in the self sampling arm (intervention arm) were invited to collect a self sample for hrHPV testing; women in the control arm were invited or reminded to undergo a screening test on a clinician sample; participation in both arms was documented; and a population minimum of 400 women.
Results 56 accuracy studies and 25 participation trials were included. hrHPV assays based on polymerase chain reaction were as sensitive on self samples as on clinician samples to detect CIN2+ or CIN3+ (pooled ratio 0.99, 95% confidence interval 0.97 to 1.02). However, hrHPV assays based on signal amplification were less sensitive on self samples (pooled ratio 0.85, 95% confidence interval 0.80 to 0.89). The specificity to exclude CIN2+ was 2% or 4% lower on self samples than on clinician samples, for hrHPV assays based on polymerase chain reaction or signal amplification, respectively. Mailing self sample kits to the woman’s home address generated higher response rates to have a sample taken by a clinician than invitation or reminder letters (pooled relative participation in intention-to-treat-analysis of 2.33, 95% confidence interval 1.86 to 2.91). Opt-in strategies where women had to request a self sampling kit were generally not more effective than invitation letters (relative participation of 1.22, 95% confidence interval 0.93 to 1.61). Direct offer of self sampling devices to women in communities that were underscreened generated high participation rates (>75%). Substantial interstudy heterogeneity was noted (I2>95%).
Conclusions When used with hrHPV assays based on polymerase chain reaction, testing on self samples was similarly accurate as on clinician samples. Offering self sampling kits generally is more effective in reaching underscreened women than sending invitations. However, since response rates are highly variable among settings, pilots should be set up before regional or national roll out of self sampling strategies.
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4823 (Published 05 December 2018)Cite this as: BMJ 2018;363:k4823