Is self-swabbing for Human Papillomavirus (HPV) recommended and what are the treatment options?

HPV Self-Sampling for Cervical Cancer Screening

Current FDA and Guideline Status

Self-collection for HPV testing is not FDA-cleared or recommended by U.S. medical organizations, despite high acceptability and feasibility demonstrated in research studies. 1

The 2021 CDC STI Treatment Guidelines explicitly state that unlike cytology, samples for HPV testing have the potential to be collected by patients and mailed to health programs for analysis, which might increase screening rates among populations where screening rates are low. However, self-collection for HPV testing remains not cleared by FDA or recommended by U.S. medical organizations. 1

Why Self-Sampling Is Not Currently Approved in the U.S.

Regulatory Barriers

• FDA-cleared HPV tests are only approved for use with cervical specimens collected by healthcare providers, not for self-collected vaginal specimens. 1
• Current FDA-approved tests include the Cobas 4800 HPV test and Onclarity HPV test for primary screening, but these clearances specify provider-collected cervical samples only. 1
• The 2020 American Cancer Society guidelines note that although self-sampling has not been approved by the FDA, it offers great potential to expand cervical cancer screening scope. 1

Clinical Context

• HPV self-sampling is superior to self-sampling for cytology testing because molecular HPV testing is less affected by specimen adequacy issues compared to cytology, which requires adequate cell collection and morphologic features. 1
• The American Cancer Society acknowledges substantial evidence demonstrating the validity of HPV self-sampling compared with cervical samples collected in clinical settings. 1

Evidence Supporting Self-Sampling Performance

Test Accuracy

Research demonstrates that self-collected vaginal swabs show:

• Sensitivity of 71.4% and specificity of 98.2% compared to provider-collected cervical samples as the gold standard in one study of trans masculine individuals. 2
• High concordance (Kappa = 0.75) between self-collected and provider-collected samples. 2

Patient Acceptability

• Over 90% of participants across multiple studies endorsed preference for self-collected vaginal swabs over provider-collected cervical swabs. 2
• Among 868 older women (ages 60-75), 58.9% preferred self-sampling, with 49.2% reporting it was very easy to perform. 3
• Over 85% of medically underserved women visiting emergency departments reported willingness to use self-sample HPV testing if available. 4
• A systematic review of 72 studies among 52,114 participants found women generally found HPV self-sampling highly acceptable regardless of age, income, or country of residence. 5

Current Approved HPV Testing Approach

Standard Screening Recommendations

Women should begin cervical cancer screening at age 21 with cytology, regardless of sexual activity onset. 6

• Ages 21-29 years: Cytology every 2-3 years. 6
• Ages 30+ years: Options include cytology alone every 3 years, co-testing (cytology + HPV) every 3 years if both negative, or primary HPV testing with cytology reflex. 6

HPV Testing Limitations

HPV testing should NOT be performed for: 1

• Deciding whether to vaccinate against HPV
• Conducting HPV tests for low-risk (non-oncogenic) HPV types (e.g., types 6 and 11)
• Providing care to persons with genital warts or their partners
• Testing persons aged <25 years as part of routine cervical cancer screening
• Testing oral or anal specimens

Treatment Options for HPV-Related Conditions

Management Based on Results

Treatment is directed at HPV-associated lesions, not the HPV infection itself. 1

• For CIN 1 or less: Repeat HPV testing with or without Pap test in 1 year. 7
• For CIN 2+ (moderate or severe dysplasia): Treatment options include ablative or excisional procedures (cryotherapy, electrocautery, laser therapy, surgical excision). 1, 7
• For genital warts: Treatment includes local approaches to remove lesions or topical pharmacologic agents. 1

Follow-Up After Treatment

• Surveillance should continue for at least 25 years after treatment for high-grade precancer. 7
• Initial post-treatment testing includes HPV test or cotest at 6,18, and 30 months. 7
• Long-term surveillance includes testing at 3-year intervals if using HPV testing or cotesting, or annual testing if using cytology alone. 7

Common Pitfalls to Avoid

• Do not use self-collected samples for HPV testing in clinical practice as they are not FDA-approved, despite research showing acceptability and reasonable performance. 1
• Do not test for low-risk HPV types (6 and 11) as this provides no clinical benefit. 1
• Do not use HPV testing as STD screening or to decide on vaccination status. 1
• Do not screen women under age 25 with HPV testing as part of routine cervical cancer screening. 1

Future Considerations

The 2020 American Cancer Society guidelines acknowledge that self-sampling offers great potential to save lives, particularly in low-income and middle-income countries and among hard-to-reach populations, though implementation in the U.S. awaits FDA approval. 1 In-person engagement with trusted community leaders and distribution of kits through clinical settings or mail-out programs have proven effective strategies for engaging underscreened populations in research settings. 8