BACKGROUND AND PURPOSE:

• Torres-Ibarra et al. (JAMA Network Open, 2019) compare 6 triage strategies to detect cervical intraepithelial neoplasia (CIN) grade ≥2 or higher among women with high-risk HPV using liquid-based cytology (LBC) and HPV-16 and HPV-18 genotyping

METHODS:

• Prospective diagnostic study
  • Forwarding Research for Improved Detection and Access for Cervical Cancer Screening and Triage (FRIDA Study)
• Setting
  • 100 primary health centers in Tlaxcala, Mexico
• Participants
  • Women aged 30 to 64 years
• Six triage scenarios for referral to colposcopy examined
  • LBC testing that found atypical squamous cells of undetermined significance (ASC-US) or worse
  • Positive results in HPV-16 genotyping
  • Positive results in HPV-18 genotyping
  • Positive results in HPV-16/HPV-18 genotyping
  • Positive results in HPV-16 genotyping or, if genotyping results were negative, reflex LBC testing that found ASC-US or worse
  • Positive results in HPV-16/HPV-18 genotyping or, if genotyping results were negative, reflex LBC testing that found ASC-US or worse
• Study design
  • All women had a pelvic exam and collection of 2 cervical samples using 2 separate cervical brushes
    • One brush was preserved for HPV DNA and other molecular testing (high-risk qualitative HPV test for 12 high-risk HPV types) and individual results for HPV-16 and HPV-18 (reflexed if high-risk HPV positive)
    • Other brush was placed in a vial for LBC testing (testing completed if high-risk HPV test positive)
  • Referred to colposcopy for the following
    • HPV genotyping results were positive for HPV-16 or HPV-18 or LBC found ASC-US or worse
    • Randomly chosen women (29%) with negative HPV-16/HPV-18 genotyping and normal LBC findings to correct for partial verification bias
• Primary outcome
  • Clinical performance of each test strategy for detection of CIN ≥2
• Secondary outcomes
  • Resource utilization of each triage scenario (measured by the number of tests performed)
  • The referral rate for colposcopy
  • The numbers of colposcopies per CIN ≥2 or higher detected

RESULTS:

• 36, 212 women were screened | 4051 women (11.2%) had high-risk HPV
  • Median age: 40 years
  • HPV-16, HPV-18, or ASC-US or worse: 1109 women
• CIN ≥2 (histology): 14.0% of women who underwent follow-up colposcopy
• Sensitivity and specificity for 3 main triage strategies were
  • LBC
    • Sensitivity: 42.9%
    • Specificity: 74.0%
  • HPV-16/HPV-18 genotyping
    • Sensitivity: 58.3%
    • Specificity: 54.4%
  • HPV-16/HPV-18 genotyping with reflex LBC
    • Sensitivity: 86.6%
    • Specificity: 34.0%
    • While yielding the highest detection rate of CIN ≥2 (110 cases detected), also generated the greatest number of colposcopies (7.2) to detect one CIN ≥2

CONCLUSION:

• When triaging women with high-risk HPV, HPV-16/HPV-18 genotyping with reflex LBC was a significantly better at detecting CIN ≥2, compared to LBC alone
• The authors suggest

The benefit of disease prevented may outweigh the cost of increasing requirements for colposcopy services in settings with limited adherence to follow-up after a positive screening result

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Learn More – Primary Sources:

Comparison of HPV-16 and HPV-18 Genotyping and Cytological Testing as Triage Testing Within Human Papillomavirus–Based Screening in Mexico

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Guidance Update: Professional Organizations Align on Cervical Cancer Screening

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