Human Papillomavirus Self-Collection

Human papillomavirus (HPV) causes nearly all cases of cervical cancer.¹ Screening is moving away from cervical cytology, which uses morphologic assessment of a sample of cervical cells, to HPV testing, which detects the presence of an active HPV infection. HPV testing is more sensitive than cytology for detecting high-grade cervical precancers, allowing screening to occur less frequently without sacrificing cancer protection.¹ Because HPV-infected cells shed from the cervix into the vagina, HPV testing of vaginal specimens using polymerase chain reaction amplification has nearly equivalent viral detection rates as cervical specimens.² This allows for a notable contribution to cervical cancer screening options: patients may collect their own vaginal samples rather than undergoing a speculum examination with a clinician. Because most individuals who develop cervical cancer are overdue for screening,¹ self-collection has the potential to reduce cancer rates by reaching those who are underscreened.^2,3

In 2024 and 2025, several vaginal self-collection devices and HPV assays received regulatory approval from the U.S. Food and Drug Administration⁴ for use in clinical settings and at home (Table 1), with additional approvals expected in 2026.^2,3

Table 1.

Combinations of Collection Device and Human Papillomavirus Assays With Regulatory Approval

Device	HPV Assay	Setting
Evalyn Brush	Abbott Alinity m	Clinic
Qvintip swab (part of simpli-COLLECT kit)	Abbott Alinity m	Clinic
Copan 5C188S FLOQSwab	BD Onclarity	Clinic
Teal Wand	Roche cobas	Home
Copan 552C FLOQSwab	Roche cobas	Clinic
Evalyn Brush	Roche cobas	Clinic

HPV, human papillomavirus.

Guidelines for using HPV self-collection in clinical practice in the United States have been developed by the 19-organization Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee² and the American Cancer Society³ (Box 1).

Box 1. Summary of Key Recommendations for Use of Human Papillomavirus Self-Collection.

• Self-collection is acceptable

• HPV-negative screening test results are managed with repeat testing in 3–5 y

• HPV-positive screening test results are managed as follows:

∘ HPV 16 or 18 (highest risk oncogenic types): refer directly to colposcopy

∘ HPV 59/56/66 (lowest risk oncogenic types): repeat HPV testing in 1 y

∘ Other HPV types: obtain a cervical cytology or p16/Ki-67 dual stain test to determine whether colposcopy is needed

HPV, human papillomavirus.

In this issue of Obstetrics & Gynecology, Qin et al⁵ describe patient perspectives on HPV self-collection before it became available in the United States. Using the 2022–2023 National Survey of Family Growth, their results represent the preferences of approximately 58.3 million women aged 21–49 years. The vast majority (72%) were open to using HPV self-collection, with 43% of patients preferring this option. Nearly one in five participants was overdue for screening, and, consistent with prior literature,⁶ a stronger preference for self-collection was noted among this group. Reasons for preferring self-collection included ease of use, convenience, privacy, and increased comfort.⁶ These data indicate the significant potential of HPV self-collection to reach underscreened individuals at high risk for cancer.

However, nearly one-third of participants preferred clinician collection, underscoring the importance of patient choice in cervical cancer screening. Research from Australia, where self-collection has been an option since 2022, indicated that patients strongly desired options when considering screening methods.⁷ In this study, clinician collection was preferred more commonly by non-Hispanic Black participants and those with lower socioeconomic status, groups that have lower rates of screening and higher rates of cancer.¹ A prior survey of underscreened, low-income participants similarly noted a preference for clinician collection among people of color.⁶ Patient concerns related to collecting an adequate self-sample, and they had greater confidence in clinician-collected samples.⁶ Choice of screening method is also important among postmenopausal individuals, a group not represented in this current study, because prior literature has demonstrated varied preferences.⁶ Providing patients choice in how they undergo cervical cancer screening is an important next step and has the potential to increase adherence to screening guidelines.

What steps are needed to make self-collection a broadly accessible option in the United States? To date, we have several self-collection device–HPV assay combinations with regulatory approval, national guidelines for screening and management, and data from this study and others indicating high levels of patient preference for this screening option. Successful implementation of HPV self-collection requires action at the patient, clinician, health care system, laboratory, and payer levels.⁸ To increase confidence in the accuracy of HPV self-collection, patients and clinicians will require education on the technique and effectiveness of specimen collection. Self-collection is already used in other contexts, including vaginitis screening, which may facilitate its adoption for cervical cancer screening. In addition, studies have demonstrated adequate self-collection of HPV specimens across diverse populations, indicating the feasibility of performing HPV self-collection in practice.⁹ Home-based collection requires additional steps, including outreach for patient education, address verification, and successful return of the test kit, similar to implementation of at-home colon cancer screening. Clinicians also need to review eligibility for HPV self-collection, because cervical specimens are preferred for those who are immunosuppressed, diethylstilbestrol-exposed, or in active follow-up after an abnormal result.^2,3

Before implementation, health care systems will need to work closely with their laboratory partners, obtain self-collection kits containing the vaginal-collection device and instructions, and establish order sets specific to self-collection in the electronic medical record. Accurate identification of vaginal or cervical specimens is imperative to guide next steps in management. Laboratory workflows for HPV-positive results differ between vaginal and cervical specimens—secondary triage testing with cytology or p16/Ki-67 dual staining can be performed on a cervical sample but not on a vaginal sample. Furthermore, new workflows at a health care–system level will need to be established for managing the 10–25% of patients with HPV-positive test results. Most patients with HPV-positive test results will need to return to the clinic for cervical specimen collection, and up to 30% of those testing positive for HPV will need direct referral to colposcopy services.

Finally, insurers must cover the test. Because screening with HPV alone has been an approved screening option since publication of the 2018 U.S. Preventive Services Taskforce guidelines,¹⁰ most insurers should reimburse the HPV test Current Procedural Terminology code, which applies to both cervical and vaginal specimens. Most insurers accept this test under their quality reporting metrics, because current quality measures from HEDIS (the Healthcare Effectiveness Data and Information Set) explicitly accept self-collected specimens for screening, as do proposed updates from the Health Services Resource Administration. However, other insurers, including Medicare, continue to require a cytology sample and currently do not accept HPV testing alone for screening. New guidelines released by the Women’s Preventive Services Initiative direct that plans cover HPV self-collection and also follow-up testing as needed to achieve diagnostic resolution.¹¹ Ensuring that gynecologic health coverage follows up-to-date guidelines is necessary to provide high-quality health care. We are at an exciting time in cervical cancer screening where we can now offer different options to patients. Expanding the availability of HPV self-collection to everyone who wants it is the next step in cancer prevention.

Biographies

Rebecca B. Perkins, MD, MSc

Jessica B. DiSilvestro, MD