Comparative effectiveness study on human papillomavirus detection methods used in the cervical cancer screening...

Area of Science:

• Gynecologic Oncology
• Public Health
• Molecular Diagnostics

Background:

• The Norwegian Cervical Cancer Screening Programme (NCCSP) integrated human papillomavirus (HPV) testing in 2005.
• This integration aimed to improve the follow-up of abnormal cytology results, including unsatisfactory, atypical squamous cells of undetermined significance (ASC-US), and low-grade squamous intraepithelial lesion (LSIL).

Purpose of the Study:

• To evaluate the short-term and long-term effectiveness of different HPV tests used within the NCCSP.
• To assess the diagnostic accuracy and clinical outcomes associated with HPV testing in routine cervical cancer screening.

Main Methods:

• A nationwide, register-based, prospective follow-up study was conducted.
• 19,065 women with repeat cytology and HPV testing after abnormal screening results (ASC-US or LSIL) between 2005-2009 were analyzed.
• Cumulative incidence of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was estimated at 6 months and 3 years post-testing.

Main Results:

• Among women with ASC-US/LSIL, the 3-year risk of CIN2+ was significantly higher in HPV-positive cases compared to HPV-negative cases across different HPV tests (Amplicor/HC2 and Proofer).
• Nearly all (close to 100%) CIN2+ cases diagnosed within 6 months were HPV-positive.
• High concordance (94-97%) was observed between initial HPV positivity and CIN2+ diagnosis within 3 years for Amplicor and HC2 tests, while the Proofer test showed lower concordance (<80%).

Conclusions:

• Triage HPV DNA testing demonstrates good overall performance for long-term cervical cancer screening.
• The management of HPV-negative women with persistent ASC-US/LSIL cytology results requires optimization to ensure adequate follow-up and prevent disease progression.