Is self-sampling (self-collection of a specimen) available for cervical cancer screening?

Self-Sampling for Cervical Cancer Screening

Self-sampling for HPV testing is NOT currently approved by the FDA and is NOT recommended for routine cervical cancer screening in the United States outside of research studies, despite strong evidence supporting its feasibility and effectiveness. 1

Current Regulatory Status and Recommendations

The American Cancer Society's 2020 guideline explicitly excludes self-sampling from clinical recommendations until FDA approval is obtained. 1, 2 All current U.S. guidelines recommend clinician-collected samples for HPV testing, whether used alone or with cytology. 2

Why Self-Sampling Shows Promise (But Isn't Ready Yet)

Evidence Supporting Future Use

HPV self-sampling has been extensively studied from the mid-1990s through the 2020s and demonstrates:

• Feasibility and acceptability as a viable screening approach, particularly for never-screened and under-screened populations 1
• Comparable sensitivity to clinician-collected samples for detecting high-grade cervical lesions when using molecular HPV testing 2, 3
• Substantially increased participation among hard-to-reach women in home-based screening programs 1
• High acceptability among women globally, regardless of age, income, or country of residence 4

Key Advantages Documented in Research

Women report multiple benefits of self-sampling including:

• Convenience and privacy 1
• Less embarrassment and anxiety 1
• Ease of use 1
• Less discomfort and pain compared with in-office specimen collection 1
• Lower cost screening opportunities 1

Critical Limitation: NOT for Cytology Testing

Self-sampling is fundamentally incompatible with cytology-based screening (Pap smears). 1, 2 The adequacy of specimen collection—including source, adequacy of cells, and morphologic features essential for cytology testing—is adversely affected by self-sampling compared with sampling by a trained professional. 1

In contrast, molecular testing for HPV DNA or RNA uses assays that are less affected by specimen adequacy, making self-sampling viable for HPV testing specifically. 1

Collection Methods

Several different methods for specimen collection may be used, including:

• Brushes 1
• Swabs (cervical swabs are most commonly accepted) 1, 4
• Vaginal patches 1
• Lavage 1

Distribution Methods Impact Uptake

The method of disseminating self-sampling test kits significantly impacts screening uptake:

• Most effective: HPV self-sampling kits offered door-to-door by health workers 1
• Less effective: Mailing kits directly to homes or requiring women to pick up their own kits 1

Prerequisites Before Clinical Implementation

When self-sampling receives FDA approval, several critical requirements must be met:

• Strict adherence to validated protocols for sample collection, storage, and transport 1, 2
• Unimpeded access to appropriate follow-up including colposcopy and treatment for positive results 1, 2
• Clear identification of target populations most likely to benefit, particularly never-screened or under-screened individuals 1, 2
• Use of FDA-approved HPV tests validated specifically for self-collected specimens 2

Populations That Will Benefit Most (Once Approved)

Self-sampling has the potential to save many lives, particularly in:

• Never-screened and under-screened populations 1
• Low-income and middle-income countries and populations 1
• Settings where some groups of women are hard to reach 1
• Women aged 30-65 years (the age group for whom HPV testing is recommended) 2

What NOT to Do

Critical caveats to avoid when self-sampling becomes available:

• Do not use self-sampling for women under age 30, as HPV testing is not recommended in this age group due to high rates of transient infections 2
• Do not use self-sampling for cytology testing due to inadequate specimen quality 1, 2
• Do not implement self-sampling without ensuring robust follow-up systems for abnormal results 1, 2
• Do not use self-sampling in high-risk populations who require more intensive surveillance 2

Global Context

While self-sampling is not approved in the United States, only 17 countries (12% of those with identified screening programs) currently recommend its use globally—nine as the primary collection method and eight to reach underscreened populations. 5 The WHO recommends HPV cervical self-sampling as an additional screening method for women aged ≥30 years. 4

Future Outlook

The American Cancer Society anticipates that self-sampling will play an increasingly prominent role in cervical cancer screening once regulatory and clinical prerequisites are in place and as supporting evidence continues to accumulate. 1 The COVID-19 pandemic has accelerated efforts to introduce HPV self-sampling globally, and it is now considered a key element in scaling up screening coverage. 5