New Guidelines for HPV Testing of Self-Collected Vaginal Specimens for Cervical Cancer Screening

By Rebecca B. Perkins, MD, MSc

Synopsis: This article outlines national consensus guidelines for the use of human papillomavirus (HPV) testing of self-collected vaginal specimens for cervical cancer screening.

Source: Perkins RB, Wolf AMD, Church TR, et al. Self-collected vaginal specimens for human papillomavirus testing and guidance on screening exit: An update to the American Cancer Society cervical cancer screening guideline. CA Cancer J Clin. 2026;76(1):e70041.

This article describes updates to the American Cancer Society’s guidelines for cervical cancer screening. The previous guidelines, released in 2020, recommended cervical cancer screening for women and individuals with a cervix beginning at age 25 years and continuing through age 65 years. Human papillomavirus (HPV) testing alone at five-year intervals was the preferred method, with concurrent cervical cytology (Pap) and HPV testing (co-testing) at five-year intervals or cytology alone at three-year intervals as allowable alternatives. Screening exit at age 65 years was recommended for those meeting certain criteria.¹

Updates relate to the use of self-collected vaginal HPV specimens for screening and simplification of screening exit criteria. In 2024 and 2025, several combinations of HPV tests and vaginal collection devices received U.S. Food and Drug Administration (FDA) approval. (See Table 1.)

The updated American Cancer Society guidelines endorse the recommendations of the Enduring Consensus Cervical Cancer Screening and Management Guidelines for the use of HPV testing of self-collected vaginal specimens for screening as follows:²

• Clinician-collected cervical specimens are preferred and self-collected vaginal specimens are acceptable for cervical cancer screening.
• When self-collected vaginal specimens are HPV-negative in the screening setting, repeat testing in three years is recommended.

Since the majority of cervical cancer occurs in people who are underscreened, the American Cancer Society recognizes the need to expand screening options.³ Screening with HPV vaginal self-collected specimens has the potential to expand screening to individuals who have not participated in clinician-collected screening because of personal or systemic factors.

Personal factors may include a history of trauma, mobility issues, or discomfort with pelvic exams.⁴ Systemic factors relate to the inability to obtain the exam because of the lack of a primary care or gynecology provider, a worsening problem in rural areas because of hospital closures and women’s healthcare deserts, and are a significant problem even for those in metropolitan areas and with private insurance.^4,5 Self-collection, either in a clinical setting or at home, can overcome these barriers and may expand screening coverage, ultimately reducing cancer rates.^6,7

When available, clinician collection is preferred for two reasons. First, clinician-collected samples contain cervical cells, allowing the laboratory to perform cytology or dual stain testing from the same sample to determine the need for colposcopy with biopsy. For most patients testing HPV-positive on a vaginal specimen, a clinic visit to perform a cytology is needed. This extra step may inconvenience patients or increase loss to follow-up prior to diagnostic resolution.⁸ Second, fewer long-term data exist on the sensitivity of self-collected vaginal specimens, and implementation in national programs shows heterogeneity in performance. For this reason, a three-year return interval is recommended following a negative result on a self-collected vaginal specimen and a five-year return interval is recommended following a negative result on a clinician-collected cervical specimen. This allows a margin of safety while additional data on the five-year performance of vaginal self-collected specimens accrues.

Screening exit criteria were revised in response to the findings that 25% of cervical cancers occur in women older than age 65 years, their mortality is double that of younger women, and two-thirds of women currently aged 64-66 years do not fulfill criteria to exit screening.^3,9,10 In addition, medical record examination found that clinicians could not access sufficient data to exit patients from screening for the majority of patients.¹¹ Recognizing that the implementation failure of existing screening exit guidelines has led to a substantial number of preventable cancers in older women, the new American Cancer Society guidelines are proactive. Rather than recommend an extensive review of medical records, a time-consuming, difficult, and non-reimbursable activity, the guidelines now recommend that all women and people with a cervix obtain screening with an HPV test at ages 60 and 65 years.

The other screening options (cytology/HPV co-testing, self-collected HPV testing, and cytology alone) also may be used for screening exit; two to three consecutive negative screens at the recommended intervals (three or five years), with the last test no earlier than age 65 years, are recommended. Because the average life expectancy for women in the United States is approximately 80 years of age and hysterectomy-corrected cervical cancer incidence rates show that cancer rates continue to increase across the lifespan, ensuring adequate screening prior to discontinuation for what may amount to decades more of healthy survival is paramount.^12,13

Rebecca B. Perkins, MD, MSc, is Professor, Department of Obstetrics and Gynecology, Tufts University School of Medicine/Tufts Medical Center, Boston.

References

1. Fontham ETH, Wolf AMD, Church TR, et al. Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society. CA Cancer J Clin. 2020;70(5):321-346.

2. Wentzensen N, Massad LS, Clarke MA, et al. Self-collected vaginal specimens for HPV testing: Recommendations from the Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. J Low Genit Tract Dis. 2025;29(2):144-152.

3. Perkins RB, Wentzensen N, Guido RS, Schiffman M. Cervical cancer screening: A review. JAMA. 2023;330(6):547-558.

4. Fuzzell LN, Perkins RB, Christy SM, et al. Cervical cancer screening in the United States: Challenges and potential solutions for underscreened groups. Prev Med. 2021;144:106400.

5. Fontenot J, Brigance C, Lucas R, Stoneburner A. Navigating geographical disparities: Access to obstetric hospitals in maternity care deserts and across the United States. BMC Pregnancy Childbirth. 2024;24(1):350.

6. Sultana F, English DR, Simpson JA, et al. High-grade cervical abnormalities and cervical cancer in women following a negative Pap smear with and without an endocervical component: A cohort study with 10 years of follow-up. Int J Cancer. 2014;135(5):1213-1219.

7. Wedisinghe L, Sasieni P, Currie H, Baxter G. The impact of offering multiple cervical screening options to women whose screening was overdue in Dumfries and Galloway, Scotland. Prev Med Rep. 2022;29:101947.

8. Olthof EMG, Aitken CA, Siebers AG, et al. The impact of loss to follow-up in the Dutch organised HPV-based cervical cancer screening programme. Int J Cancer. 2024;154(12):2132-2141.

9. Feldman S, Cook E, Davis M, et al. Cervical cancer incidence among elderly women in Massachusetts compared with younger women. J Low Genit Tract Dis. 2018;22(4):314-317.

10. Mills JM, Morgan JR, Dhaliwal A, Perkins RB. Eligibility for cervical cancer screening exit: Comparison of a national and safety net cohort. Gynecol Oncol. 2021;162(2):308-314.

11. Alimena S, Lykken JM, Tiro JA, et al. Accessibility of criteria to exit cervical cancer screening at age 65 years in the electronic health record. O G Open. 2024;1(3):32.

12. Harper S, Riddell CA, King NB. Declining life expectancy in the United States: Missing the trees for the forest. Annu Rev Public Health. 2021;42(1):381-403.

13. Beavis AL, Gravitt PE, Rositch AF. Hysterectomy-corrected cervical cancer mortality rates reveal a larger racial disparity in the United States. Cancer. 2017;123(6):1044-1050.