Routine cervical screening with primary HPV testing and cytology triage protocol in a randomised setting

Area of Science:

• Gynecology
• Oncology
• Public Health

Background:

• The effectiveness of high-risk human papillomavirus (hrHPV) testing in primary cervical cancer screening requires further evaluation.
• Routine implementation of hrHPV testing in screening programs needs assessment for its impact on program effectiveness.

Purpose of the Study:

• To assess the cross-sectional relative validity of routine hrHPV screening compared to conventional cytology in the first year of implementation.
• To determine if primary hrHPV testing enhances the effectiveness of cervical screening programs.

Main Methods:

• A randomized evaluation design was employed, allocating women to either primary hrHPV screening (n=7060) or conventional cytological screening (n=7089).
• In the hrHPV arm, positive hrHPV results were triaged with cytology to determine the need for colposcopy referral.

Main Results:

• The hrHPV screening arm resulted in more colposcopy referrals (relative risk 1.51) compared to the conventional arm.
• Primary hrHPV testing showed lower specificity (91.5-92.1%) than conventional cytology (99.2-99.6%).
• Cytology triage following a positive hrHPV test improved specificity (98.7-99.3%) to levels comparable with conventional cytology.

Conclusions:

• Primary hrHPV testing offers increased sensitivity for detecting cervical lesions but sacrifices specificity.
• Implementing cytology triage after hrHPV testing significantly enhances specificity, making it a viable option for primary cervical screening.