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.
FootnotesContributors: MA designed the study concept and protocol. MA and PC formulated the clinical questions and the definition of PICOS components. MA elaborated data extraction forms for the review update. MA, SBS, ST, and FS extracted data. MA conducted the statistical analysis. MA, SS, and PC wrote the manuscript. SBS, ST, FS, and PC conducted a critical revision of the manuscript. MA, SBS, and PC revised and approved the manuscript before submission. Members of the Collaboration on Self sampling and HPV Testing (MS, VS, DC, AW, JG, NW, CMZ, JJ, FARG, WKH, JSS, TCR, MHE, KMS, RAS, and MAG) provided feedback on the study protocol, performed and verified the initial part of study selection, and reviewed the manuscript. All authors had full access to the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. MA is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: This systematic review was supported by Global Coalition Against Cervical Cancer (New York, NY, USA) through a grant by the US Centers for Disease Control and Prevention through its cooperative agreement with the National Network of Public Health Institutes and subaward to GC3, and by High Authority for Health (Paris, France). MA was supported by the COHEAHR Network (grant No 603019), funded by the 7th Framework Programme of DG Research and Innovation, European Commission (Brussels, Belgium) and the German Guideline Program in Oncology (GGPO, Hannover, Germany). The funder had no role in the study design, data collection, data interpretation, or writing of the report.
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.
Ethical approval: Not required.
Patient consent: Patient consent not required.
Data sharing: No additional data are available.
The manuscript's guarantor (MA) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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