HPV Testing in Clinics: Evidence-Based Guidelines
HPV testing in clinics should be used strategically based on patient age and clinical indication—specifically for primary screening or co-testing in women aged ≥30 years, for triage of ASC-US cytology in women aged ≥21 years, and for post-treatment surveillance, but should NOT be used as a standalone test in women under 25 years or for STD screening purposes. 1
Age-Specific HPV Testing Recommendations
Women Under 25 Years
- Do not perform HPV testing for routine cervical cancer screening in women aged <25 years 1
- HPV prevalence is extremely high in this age group (up to 81% in sexually active adolescents), but infections are typically transient and rarely progress to cancer 1
- The single exception is adolescents with HIV infection, who should begin screening 1 year after onset of sexual activity but no later than age 21 years using cytology alone (not primary HPV testing) 1
Women Aged 25-29 Years
- Pap test alone every 3 years is the recommended screening method 2, 3
- HPV testing is not recommended for primary screening in this age group 1
- HPV testing may be used for triage of ASC-US cytology results in women aged ≥21 years 1
Women Aged 30-65 Years
- Co-testing (Pap test plus HPV DNA test) every 5 years is the preferred approach 2, 3
- Acceptable alternatives include Pap test alone every 3 years or primary HPV testing alone every 5 years 2
- Co-testing maximizes cancer prevention while reducing false-positives compared to younger age groups 2
- Primary HPV testing shows 51% higher detection of high-grade lesions but the benefit-to-harm ratio only becomes favorable at age 30 and above 2
FDA-Cleared HPV Tests and Their Approved Uses
Tests Cleared for Primary Screening
Only two tests are FDA-cleared for primary cervical cancer screening 1:
- Cobas 4800 HPV test (Roche Molecular Diagnostics)
- Onclarity HPV test (Becton Dickinson)
Both detect 14 oncogenic HPV types (16,18,31,33,35,39,45,51,52,56,58,59,66,68) plus individual genotyping for types 16 and 18 1
Tests NOT Cleared for Primary Screening
The following tests should only be used with cytology or for triage of abnormal results, not as standalone primary screening 1:
- Hybrid Capture 2 High-Risk HPV DNA test (Qiagen)
- Cervista HPV High-Risk DNA and HPV 16/18 DNA tests (Hologics)
- APTIMA HR HPV test (Gen Probe)
Critical pitfall: Using non-approved tests for primary screening violates FDA clearance and may lead to inappropriate patient management 1
Clinical Indications Where HPV Testing IS Appropriate
1. Triage of ASC-US Cytology
- HPV testing is recommended for women aged ≥21 years with ASC-US results 1, 3
- Three management options exist: HPV triage testing, repeat Pap tests at 6 and 12 months, or prompt colposcopy 2
- This is the most cost-effective use of HPV testing in younger women 4
2. Post-Treatment Surveillance
- HPV testing should occur at least 6-12 months after excisional or ablative therapy 1
- A negative HPV test has 99-100% negative predictive value for remaining free of intraepithelial neoplasia 1
- In the absence of compelling risk factors (large lesion, positive margins, endocervical involvement), test at 12 months 1
3. Follow-Up After Abnormal Screening
- HPV testing can be used for follow-up after colposcopy with no CIN 2/3 found 1
- Useful for monitoring after treatment of cervical precancers 1
Clinical Situations Where HPV Testing Should NOT Be Performed
The following are absolute contraindications to HPV testing 1:
- Deciding whether to vaccinate against HPV
- Testing for low-risk (nononcogenic) 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
- STD screening purposes 5
Common pitfall: Pap tests should not be considered screening tests for STDs, and HPV testing is not an STD screening tool 5
Special Populations
HIV-Positive Individuals
- Do not use primary HPV testing in individuals with HIV 1
- Use conventional or liquid-based cytology (Pap test) as the primary screening method 1
- Co-testing (cytology and HPV test) can be done in individuals aged ≥30 years with HIV 1
- Annual screening is recommended initially; after 3 years of consecutive normal results, the interval can be increased to every 3 years 1
- Lifelong screening is recommended among persons with HIV infection 1
Pregnant Women
- Follow the same screening recommendations as non-pregnant women 2, 3
- Conventional or liquid-based cytology can be safely obtained during pregnancy 1
HPV-Vaccinated Women
- Screen using the same recommendations as unvaccinated women 2, 3
- Vaccination status does not change screening protocols 2, 3
Management of Discordant Results (HPV-Positive, Pap-Negative)
Approximately 5% of women have HPV-positive results with normal Pap tests 6:
- This rate is similar across diverse populations, including underserved women 6
- HPV 16/18 genotyping is identified in only 14% of discordant women 6
- For women aged ≥30 years with normal cytology and positive HPV, repeat cytology at 6 and 12 months or repeat HPV testing at 12 months 1
Implementation Considerations for Clinics
Laboratory Requirements
- All HPV testing must be performed in CLIA-certified laboratories 1
- Use only FDA-cleared HPV assays for their approved indications 1
Patient Education Gaps
- Only 7% of women find HPV testing acceptable as a screening method 7
- 92.2% of women remain unaware that HPV testing can replace Pap testing for screening 7
- Only 20.6% know that women aged 30-65 can be screened every 5 years with co-testing or primary HPV screening 7
- Proactive patient education is essential before implementing primary HPV screening 7
Self-Collection
- Self-collection for HPV testing is not FDA-cleared or recommended by U.S. medical organizations 1
- While it has potential for increasing screening rates in underserved populations, it remains investigational 1