{"doi":"10.3322/caac.70047","title":"Human papillomavirus self‐collection: The long road from scientific evaluation to implementation in screening programs","abstract":"The understanding that persistent infections with human papillomavirus (HPV) cause nearly all cervical cancers has led to important cervical cancer prevention approaches: HPV vaccination is highly efficacious at preventing HPV infection when administered before infection occurs. In cervical cancer screening, HPV testing has higher sensitivity, provides longer reassurance when a test is negative, and has an overall better tradeoff of benefits and harms compared with cytology.1 Consequently, HPV testing is gradually replacing cytology as a primary screening test in screening programs worldwide. An additional benefit of HPV testing is that it can be conducted from self-collected vaginal specimens, with high concordance to clinician collected specimens. The article by Perkins et al.2 describes the adoption of clinical guidelines for HPV self-collection developed by the Enduring Guidelines effort3, 4 for the American Cancer Society cervical cancer screening guideline.5 Using self-collected specimens for cervical cancer screening has great promise to expand screening to unscreened and underscreened populations who may not have access to clinician-based sampling or who may decide not to participate in screening to avoid pelvic examinations. HPV self-collection is not a new development—the first studies evaluating self-collection were conducted in the 1990s and focused on different sampling strategies, including vaginal lavages, tampon collections, and vaginal brush devices.6-9 Of these, vaginal sampling devices were the most successful and have become the standard for HPV self-collection today. More recently, urine-based HPV testing has been evaluated as a possible alternative to clinician and brush-based self-collection, with heterogeneous efficacy results to date.10 Since the initial proof-of-concept studies, HPV self-collection has been evaluated in many, mostly cross-sectional studies, as summarized in a series of systematic reviews.11-14 The systematic reviews demonstrate that polymerase chain reaction (PCR)-based HPV tests have high agreement for detection of HPV and cervical precancer between clinician-collected and self-collected specimens. They have also demonstrated the high acceptability of HPV self-collection, with several studies indicating that screening participants prefer self-collection over clinician-collection. There is strong evidence that high sensitivity for precancer detection using self-collected samples is only achieved with PCR-based HPV DNA tests, as opposed to signal amplification or messenger RNA-based tests, which are not considered equivalent. Several components need to be considered when evaluating HPV self-collection, including the type of HPV assay, the type of collection device, the type of storage until processing (e.g., dry storage vs. liquid storage), and the sample dilution at the time of transfer to a liquid buffer before testing. Each of these factors may affect performance and has to be evaluated in the context of the proposed self-collection approach. The regulatory evaluation of HPV self-collection, which is a requirement for clinical use in the United States, considers specific combinations of tests, devices, buffers, and processing approaches rather than providing blanket approval for HPV self-collection. To date, all evaluations for regulatory approval were based on concordance of HPV detection, not identification of precancers. Two different regulatory pathways have been used for self-collection in the United States. Initially, self-collection approaches using specific devices were evaluated as extended indications for HPV tests already approved for primary HPV screening, leading to approval for self-collection in a clinical setting.3 Recently, a new self-collection device for home collection was approved specifically for use with an HPV assay that was previously approved for primary HPV screening.15 Clinical and regulatory evaluation of other home-collection approaches is currently und","journal":"CA A Cancer Journal for Clinicians","year":2025,"id":549178,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9549,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1443376,"name":"Armando Baena","orcid":"0000-0001-8717-6911","position":1,"is_corresponding":false},{"id":50161,"name":"Nicolas Wentzensen","orcid":"0000-0003-1251-0836","position":0,"is_corresponding":true}],"reference_count":12,"raw_metadata":null,"created_at":"2026-07-19T02:54:07.823422Z","pmid":"41342777","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}