What are the next steps after a positive Human Papillomavirus (HPV) result via the Aptima assay?

Management of Positive HPV Aptima Test

For women ≥30 years with a positive high-risk HPV test (including Aptima) and normal cytology, repeat co-testing with both cytology and HPV at 12 months is the recommended management approach. 1

Age-Specific Management Algorithm

Women ≥30 Years Old with HPV+ and Normal Cytology

• Repeat cytology and HPV testing at 12 months is the standard approach for cytology-negative, HPV-positive women 1
• If persistently HPV positive at 12 months (regardless of cytology result), refer for colposcopy 1
• If both tests are negative at 12 months, return to routine screening in 3 years 1
• If cytology becomes abnormal (ASC-US or greater) at follow-up, refer for colposcopy 1

Special Consideration: HPV 16/18 Genotyping

• If HPV 16 or 18 positive (even with normal cytology), immediate colposcopy is recommended rather than waiting 12 months 1, 2
• For HPV 18 positive cases specifically, endocervical sampling at colposcopy is recommended due to association with adenocarcinoma 2
• Women with other high-risk HPV types (non-16/18) can safely return in 1 year for repeat testing 2

Women <30 Years Old

• HPV testing should not be used for routine screening in women under 30 years due to high prevalence and spontaneous clearance rates 1
• If HPV testing was performed (e.g., for ASC-US triage), management depends on cytology results, not HPV status alone 1

Understanding the Aptima Test

The Aptima HPV assay is an mRNA-based test that detects E6/E7 oncogene expression from 14 high-risk HPV types, which differs from DNA-based tests 1, 3. This test has:

• Higher specificity (43% vs 39%) compared to DNA-based tests like Hybrid Capture 2, while maintaining equivalent sensitivity (97%) for detecting high-grade cervical lesions 3, 4
• Better positive predictive value (25% vs 16%) for detecting biopsy-confirmed high-grade lesions 3
• Detection of active viral transcription rather than just viral presence, potentially identifying clinically relevant infections more accurately 4, 5

Risk Stratification Based on HPV Results

High-Risk Situations Requiring Immediate Colposcopy:

• HPV 16 positive (37% risk of CIN2+ in ASC-US patients) 6
• HPV 18/45 positive (15.9% risk of CIN2+ in ASC-US patients) 6
• Two consecutive positive HPV tests regardless of cytology 2
• Any abnormal cytology with positive HPV 1, 2

Lower-Risk Situations Allowing Surveillance:

• Other high-risk HPV types (non-16/18) with normal cytology: 14.3% risk of CIN2+ 6
• Preceded by negative HPV test or cotest within past 5 years: can defer colposcopy and follow up in 1 year 1, 2

Critical Counseling Points

Normalize the diagnosis to reduce anxiety and stigma:

• HPV is extremely common; most sexually active persons acquire HPV at some point 1
• Most HPV infections clear spontaneously within 6-24 months; 60% of HPV-positive women become negative within 6 months 1
• A positive HPV test does not indicate cervical cancer; it indicates increased risk requiring monitoring 1
• HPV can remain dormant for years before detection; positive results do not imply recent acquisition or infidelity 1

Emphasize the importance of follow-up:

• The risk of undetected CIN2+ in cytology-negative, HPV-positive women is relatively low (2.4-5.1%) but requires surveillance 1
• Missing follow-up appointments is the primary pitfall that can lead to progression of undetected disease 2

Common Pitfalls to Avoid

• Do not test for low-risk HPV types (HPV 6,11) as they have no clinical utility in cervical cancer screening 1, 2
• Do not use HPV testing alone for initial triage of abnormal glandular cells (AGC) 1
• Do not perform HPV testing in women <25 years as part of routine screening 1
• Do not use Aptima for oral or anal specimens; it is only FDA-cleared for cervical specimens 1
• Ensure adequate follow-up systems are in place, as loss to follow-up is a major barrier to effective management 2

Prevention and Risk Reduction

• Consistent condom use can reduce risk of cervical HPV infection and may decrease clearance time in infected women 1
• Smoking cessation counseling should be provided, as smoking contributes to CIN progression 1
• HPV vaccination is recommended even for women with current HPV infection, as it protects against other high-risk types 1