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#Grand Rounds

HPV Genotyping and Cytology for hrHPV: What Screening Combination is Best for CIN Detection?

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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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Screening for Cervical Cancer in the Woman at Average Risk
Best Strategies for Triage of HPV-Positive Women in Cervical Cancer Screening?
How Frequently Should We Re-Screen Following a Negative HPV result?
What is the Most Efficient Method for Cervical Cancer Screening?

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