Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses

Marc Arbyn, Sara B Smith, Sarah Temin, Farhana Sultana, Philip Castle, Collaboration on Self-Sampling and HPV Testing, Marc Arbyn, Sara B Smith, Sarah Temin, Farhana Sultana, Philip Castle, Collaboration on Self-Sampling and HPV Testing

Abstract

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.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: MA is principal investigator of the VALGENT (Validation of HPV GENotyping Test) and VALHUDES (VALidation of HUman papillomavirus assays and collection DEvices for HPV testing on Self samples and urine samples) framework. Both protocols provide a template for HPV test comparison and validation on clinician samples and self samples, respectively. Manufacturers of HPV assays and devices for self collection can participate, under the condition of provision of test kits and funding for laboratory testing and statistical analyses to the employing institutions. Researchers did not receive any personal funding. SS was supported in part by unrestricted educational grants to the Global Coalition Against Cervical Cancer from Rovers, BD, QIAGEN, and Roche; a contract from Chengdu Genegle Biotechnology Co, Ltd; and has received cervical screening tests and diagnostics at a reduced or no cost for research from BD, Hologic, Rovers, Arbor Vita Corp, and Trovagene. PC has received cervical screening tests and diagnostics at a reduced or no cost for research from Roche, BD, Cepheid, and Arbor Vita Corporation.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Fig 1
Fig 1
Meta-analysis of the accuracy, for hrHPV assays for CIN2+ based on signal amplification and polymerase chain reaction for self samples and clinician samples in primary cervical cancer screening. Estimates are derived from a bivariate model for pooling of diagnostic data
Fig 2
Fig 2
Difference in participation rate between the self sampling and the control arms of randomized trials. Cyto=cytology; HPV=human papillomavirus; VIA=visual inspection after application of acetic acid

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Source: PubMed

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