Human papillomavirus testing for triage in a referral population

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Cervical Cancer Screening

Background:

• Cervical cancer screening relies on Pap smears and increasingly on human papillomavirus (HPV) testing.
• Triage methods are crucial for managing abnormal screening results efficiently and accurately.
• The Digene HPV Assay Hybrid Capture System has been considered for use in cervical cancer screening algorithms.

Purpose of the Study:

• To evaluate the Digene HPV Assay Hybrid Capture System as a triage method for cervical intraepithelial neoplasia (CIN) 2 or greater.
• To compare the performance of HPV testing within different triage algorithms based on Pap smear results.

Main Methods:

• Retrospective analysis comparing HPV assay results with final tissue diagnosis of CIN2+.
• Stratification of results based on Pap smear findings (e.g., atypical squamous cells of undetermined significance - ASCUS).
• Evaluation of four distinct triage algorithms incorporating HPV testing.

Main Results:

• Triage algorithms involving HPV testing demonstrated significant false-negative rates for detecting CIN2 and CIN3, missing 48-67% of cases.
• While cost savings were observed by withholding colposcopy for repeat ASCUS with negative HPV, this strategy missed high-grade lesions.
• HPV high-risk positive results correlated with high-grade histology but were associated with unacceptable false-negative rates.

Conclusions:

• The Digene HPV Assay Hybrid Capture System, as evaluated, exhibited significant limitations as a triage method due to false negatives.
• The HPV low-risk test component was deemed not clinically useful.
• The tested HPV assay algorithms were considered poor methods for triaging patients in this specific population, necessitating alternative strategies.