What is the Human Papillomavirus (HPV) self-swab test called for women 21 to 65 years old?

HPV Self-Swab Test Terminology

The HPV self-swab test does not have a single standardized commercial name—it is generally referred to as "HPV self-sampling," "HPV self-collection," or "vaginal self-swab for HPV testing" in clinical practice and guidelines. 1

Current Status and Terminology

The test involves a woman collecting her own vaginal specimen using a swab or brush device, which is then sent for high-risk HPV DNA testing. 2, 3 The guidelines and literature consistently use descriptive terms rather than a proprietary name:

• "HPV self-sampling" is the most common term in international guidelines 3
• "Self-collected vaginal swab for HPV testing" is used in U.S. literature 4
• "Vaginal self-collection" appears in clinical studies 2, 5

Important Clinical Context

HPV self-collection is not currently FDA-approved or recommended by U.S. guidelines for routine cervical cancer screening. 6 The 2019 guidelines note that "HPV testing with self-sampling specimen collection at home" remains a potential future change to screening protocols but is not yet standard practice. 1

Current FDA-Approved HPV Testing

FDA-approved HPV DNA tests are only cleared for use with cervical specimens collected during clinical examinations by healthcare providers, not for self-testing. 6 Available FDA-approved tests include:

• Hybrid Capture 2 High-Risk HPV DNA test 1
• Cervista HPV High-Risk test 1
• Cervista HPV 16/18 test 1

Collection Devices Used in Research

When self-collection has been studied, various devices have been employed:

• Dry swabs (most common and preferred by patients) 7
• Evalyn Brush (cytobrush device) 5
• FTA cartridge (dry filter card) 7
• Cervical swab applied to collection medium 2

Clinical Performance

Research demonstrates that self-collected vaginal swabs for HPV testing show sensitivity of 61-84% for detecting high-grade cervical lesions compared to provider-collected samples, with specificity of 97-98%. 2, 5, 4 The test is highly acceptable to women, with 79-90% preferring self-collection over provider collection. 5, 3

Key Limitations for Current Practice

Self-collection for HPV testing is not FDA-cleared or recommended by U.S. medical organizations for routine screening. 6 Women ages 21-65 should continue following standard screening recommendations with provider-collected specimens. 8 Self-collection remains primarily a research tool and potential future option to increase screening participation among underscreened populations. 1