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: Wentzensen N, Massad LS, Clarke MA, et al; Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. 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; Feb 21. doi: 10.1097/LGT.0000000000000885. [Online ahead of print].
This article by Wentzensen et al describes national consensus guidelines for human papillomavirus (HPV) testing of self-collected vaginal specimens for cervical cancer screening.1 The Enduring Consensus Cervical Cancer Screening and Management Guidelines (hereafter referred to as Enduring Guidelines) is a standing committee to provide regular updates of the 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors (hereafter referred to as 2019 Guidelines) for new technologies and approaches that were not included in the 2019 Guidelines process.2 The Enduring Guidelines effort includes experts in cervical cancer prevention, as well as representatives from 19 national organizations, including federal organizations, professional medical societies, and patient advocacy groups.3
The use of self-collected specimens for HPV testing was approved by the U.S. Food and Drug Administration (FDA) in May 2024.4 Two tests and swab combinations currently are approved: BD Onclarity with the Copan swab and Roche cobas with either the Copan swab or Evelyn brush. Both Roche cobas and BD Onclarity also are approved for primary HPV screening using clinician collection. A third primary HPV test, Abbott Alinity, currently is not approved for self-collection. At this time, both the Roche cobas and BD Onclarity tests are approved for use in clinical settings; no tests currently have FDA approval for home use. Although FDA approval did specify the test/swab combinations and clinical use setting, the approvals did not provide guidance on the management of negative and positive HPV test results. Therefore, guidelines for the management of HPV test results on self-collected vaginal specimens for cervical cancer screening were developed by the Enduring Guidelines committee.
Self-collection of vaginal specimens for HPV testing represents an important advance in screening, since it allows patients to collect their own samples without the need for a speculum exam. This can overcome barriers, including patient discomfort, lack of availability of clinicians who perform pelvic exams, and lack of appointments or healthcare access.5
Systematic literature reviews indicated overall similar performance comparing self-collected and clinician-collected samples, although methods were heterogenous and some studies indicated a small decrease in sensitivity.6-10 However, the majority of patients with a positive HPV test will need to have a follow-up visit with a clinician to perform a Pap test or p16ki67 dual stain test, and approximately half of these patients will need a third visit for a colposcopy with biopsy.11 Experience in one national program found a fourfold higher loss to follow-up among patients with positive results on self-collected HPV tests.12 Therefore, attention to management of HPV-positive test results is critical to successful implementation of this new technology.
The guidelines for the use of HPV testing of self-collected vaginal specimens are as follows:
- 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.
- When self-collected vaginal specimens are positive for HPV 16 and/or 18, direct referral for colposcopy with concurrent cytology collection is recommended.
- When self-collected vaginal specimen HPV test results are positive for HPV (untyped); negative for HPV 16/18 and positive for HPV HR12 (other); or negative for HPV 16/18 and positive for HPV 45, 33/58, 31, 52, 35/39/68, 51, or combinations thereof, obtaining a clinician-collected cervical specimen for cytology or dual stain is recommended. Subsequent management of cytology or dual-stain results per management guidelines is recommended.
- When self-collected vaginal specimen HPV test results are positive for HPV types 56/59/66 and no other carcinogenic types, one-year repeat testing is recommended (aII). If HPV-positive for any HPV type at the one-year follow-up, colposcopy is recommended.
- In the surveillance setting, clinician-collected cervical specimens are preferred. If a clinician-collected cervical specimen cannot be obtained, a self-collected vaginal specimen is acceptable following shared decision-making. If a self-collected vaginal specimen is obtained, management per 2019 Guidelines is recommended.
Commentary
Self-collected vaginal HPV tests are not meant to replace traditional screening for individuals who have been obtaining regular screening from their clinicians using a speculum exam and wish to continue doing so. Clinician-collected cervical samples have the advantage that the laboratory can run both the HPV test and a Pap test or p16/Ki67 dual stain as needed from the same sample. However, some patients may wish to avoid a speculum exam, and cervical cancer screening with a speculum exam may not be available to others, thus self-collection of HPV testing represents an important method to expand screening.
Because long-term follow-up data are not yet available for self-collected specimens, and some data show a small decrease in sensitivity with self-collected vaginal specimens, a shorter interval of three years following a negative test is recommended to provide a margin of safety while additional data accrue. Follow-up after a negative HPV test with a clinician-collected sample is five years.
HPV genotyping can be very useful for cervical cancer prevention, since cancer risk varies dramatically by genotype. HPV 16 and 18 together account for approximately 70% of cervical cancers; therefore, proceeding directly to colposcopy with biopsy is warranted when infection with either of these types is found.13 Since the sensitivity of colposcopy is variable, collection of a Pap test at the time of cytology is recommended.13,14
In contrast, the cancer risk associated with HPV 59, 56, and 66 is quite low — these types together account for < 5% of cervical cancers.15 Therefore, when these types are found on a self-collected specimen, the patient may return in one year. No immediate follow-up is needed.16
For all other HPV types or for pooled HPV results without specific type information, an additional triage test is required to determine the need for colposcopy with biopsy. Patients with these results must return to the clinician for collection of a Pap test or p16ki67 dual stain. If the results on the Pap test or p16ki67 dual stain are negative, the patient may return in one year. If the Pap test results are atypical squamous cells of uncertain significance (ASC-US) or higher or if the p16ki67 dual stain is positive, colposcopy is recommended.
Regardless of HPV genotype, colposcopy is recommended if the patient remains HPV-positive at the one-year follow-up (i.e., twice consecutively).
When patients are in follow-up after abnormal results (defined as surveillance), clinician-collected cervical samples are recommended for two reasons: very limited data exist on self-collected specimens in this setting and up to half of these patients test HPV-positive and, thus, would require a speculum exam for triage test collection.
Rebecca B. Perkins, MD, MSc, is Professor, Department of Obstetrics and Gynecology, Tufts University School of Medicine/Tufts Medical Center, Boston.
References
1. Wentzensen N, Massad LS, Clarke MA, et al; Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee. 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; Feb 21. doi: 10.1097/LGT.0000000000000885. [Online ahead of print].
2. Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020;24(2):102-131.
3. Wentzensen N, Garcia F, Clarke MA, et al. Enduring Consensus Guidelines for Cervical Cancer Screening and Management: Introduction to the Scope and Process. J Low Genit Tract Dis. 2024;28(2):117-123.
4. U.S. Food and Drug Administration. FDA Roundup: May 17, 2024. Published May 17, 2024. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-17-2024
5. Fontenot HB, Fuzzell L, Brownstein NC, et al. Health care provider willingness to recommend self-collected tests for human papillomavirus: A mixed methods examination of associated factors. Womens Health Issues. 2024;34(5):506-517.
6. Arbyn M, Verdoodt F, Snijders PJF, et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: A meta-analysis. Lancet Oncol. 2014;15(2):172-183.
7. Arbyn M, Smith SB, Temin S, et al; Collaboration on Self-Sampling and HPV Testing. Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: Updated meta-analyses. BMJ. 2018;363:k4823.
8. Arbyn M, Castle PE, Schiffman M, et al. Meta-analysis of agreement/concordance statistics in studies comparing self- vs clinician-collected samples for HPV testing in cervical cancer screening. Int J Cancer. 2022;151(2):308-312.
9. Arbyn M, Latsuzbaia A, Castle PE, et al. HPV testing of self-samples: Influence of collection and sample handling procedures on clinical accuracy to detect cervical precancer. Lancet Reg Health Eur. 2022;14:100332.
10. Inturrisi F, Aitken CA, Melchers WJG, et al. Clinical performance of high-risk HPV testing on self-samples versus clinician samples in routine primary HPV screening in the Netherlands: An observational study. Lancet Reg Health Eur. 2021;11:100235.
11. Clarke MA, Wentzensen N, Perkins RB, et al. Recommendations for use of p16/Ki67 dual stain for management of individuals testing positive for human papillomavirus. J Low Genit Tract Dis. 2024;28(2):124-130.
12. 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.
13. Schiffman M, Castle PE, Jeronimo J, et al. Human papillomavirus and cervical cancer. Lancet. 2007;370(9590):890-907.
14. Stuebs FA, Schulmeyer CE, Mehlhorn G, et al. Accuracy of colposcopy-directed biopsy in detecting early cervical neoplasia: A retrospective study. Arch Gynecol Obstet. 2019;299(2):525-532.
15. Bouvard V, Wentzensen N, Mackie A, et al. The IARC perspective on cervical cancer screening. N Engl J Med. 2021;385(20):1908-1918.
16. Massad LS, Clarke MA, Perkins RB, et al. Applying results of extended genotyping to management of positive cervicovaginal human papillomavirus test results: Enduring Guidelines. J Low Genit Tract Dis. 2025; Jan 10. doi:10.1097/LGT.0000000000000865. [Online ahead of print].
This article outlines national consensus guidelines for the use of human papillomavirus (HPV) testing of self-collected vaginal specimens for cervical cancer screening.
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