HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature

Abstract

Identifying and reaching women at higher risk for cervical cancer is all-important for achieving the ambitious endpoints set in 2020 by the WHO for global cervical cancer control by 2030. HPV-based (vaginal) self-sampling (SS) represents a cost-effective screening strategy, which has been successfully implemented during the last decade both in affluent and constrained settings. Among other advantages, SS strategies offer convenience, diminished costs, flexibility to obtain a sample in the office or home, avoiding a pelvic exam and uncomfortable appointment with a healthcare professional, as well as social and cultural acceptability. SS implementation has been globally boosted during the COVID-19 pandemic. In pragmatic terms, social distancing, local lockdowns, discontinuation of clinics and reallocation of human and financial resources challenged established clinician-based screening; self-collection strategies apparently surpassed most obstacles, representing a viable and flexible alternative. With time, sufficient reassuring data has accumulated regarding specially designed SS devices, aspects of sample preparation, transport and storage and, importantly, optimization of validated PCR-based HPV testing platforms for self-collected specimens. Suboptimal rates of clinical follow-up post-SS screening, as well as overtreatment with reliance solely on molecular assays, have both been documented and remain concerning. Therefore, effective strategies are still required to ensure linkage to follow-up testing and management following positive SS results by trained health professionals with knowledge of HPV biology and management algorithms. Because of the prolonged SS screening intervals, implementation data are limited regarding subsequent screening rounds of SS-screened individuals; however, these are accumulating gradually. With further refinement of assays and validation of novel biomarkers in self-collected samples, there is a clear potential for increasing SS accuracy and PPV. The potential differentiation of self-collection protocols for vaccinated versus non-vaccinated individuals also represents an open issue. In conclusion, HPV-based self-collection techniques can effectively address limited uptake alongside other conventional cervical screening drawbacks; however, assays, logistics and infrastructures need further optimization to increase the efficacy, effectiveness and cost-effectiveness of SS approaches.

Consistency in human papillomavirus type detection between self‐collected vaginal specimens and physician‐sampled cervical specimens

“…Arbyn et al's 23 recent meta‐analysis of HPV test agreement indicated that pooled overall agreement was 88.7% (95% CI: 86.3%–90.0%), positive agreement was 84.6% (95% CI: 79.7%–88.7%). In a separate meta‐analysis, the reported sensitivities were 77% (95% CI: 69%–82%) for CIN2+ detection from self‐samples and 93% (95% CI: 89%–96%) from physician samples 24 …”

“…In a separate meta-analysis, the reported sensitivities were 77% (95% CI: 69%-82%) for CIN2+ detection from self-samples and 93% (95% CI: 89%-96%) from physician samples. 24 Our trial flagged 140 discordant HPV positive results; 71 were negative in self-collected yet positive in physician-sampled specimens, while 69 positives in the self-collected were negative in physician-sampled specimens. This disparity was notably higher among participants previously treated for cervical lesions.…”

Systematic Reviews to Inform Practice, November/December 2023

“…Performing quality speculum examinations on patients of size is a common source of uncertainty for providers, with higher rates of insufficient cervical specimens in patients with overweight and obese BMIs. Fortunately, the most recent guidelines for cervical cancer screening allow for HPV testing alone as an option, 8 and a recent review of current evidence determined that self‐collection is an acceptable strategy for increasing cervical cancer screening rates in some populations 1,9 . Patients who are reluctant to receive pelvic examinations for any reason should be offered self‐collection of vaginal secretions to ensure that they remain up to date with screening recommendations as the key step in minimizing cervical cancer and its associated health disparities.…”

Human papillomavirus testing using HPV APTIMA® assay and an external cellularity control in self‐collected samples

“…The screening test must be sensitive to avoid missing a clinically relevant HPV infection 2,3 . The use of self‐collected vaginal samples has been proposed to increase the coverage of screening to difficult‐to‐reach women considering the high incidence of cervical cancer 4–6 . Many commercial molecular assays are available for the detection of high‐risk HPV (HR‐HPV) genomic DNA or mRNA in the screening setting 7,8 .…”

“…2,3 The use of self-collected vaginal samples has been proposed to increase the coverage of screening to difficult-to-reach women considering the high incidence of cervical cancer. [4][5][6] Many commercial molecular assays are available for the detection of highrisk HPV (HR-HPV) genomic DNA or mRNA in the screening setting. 7,8 HR-HPV tests are based on detection of portions of their genomic DNA by hybridization, real-time PCR, or end-point PCR amplifications.…”