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Human papillomavirus testing alone was more sensitive than conventional cytology for detecting cervical intraepithelial neoplasia, and adding liquid-based cytology to HPV testing only increased the rate of false positives, according to a phase I report from a two-phase randomized controlled trial.
Dr. Guglielmo Ronco of the Centro per la Prevenzione Oncologica, Turin, Italy, and his colleagues from the New Technologies for Cervical Cancer Working Group enrolled more than 33,000 women from nine Italian cancer-screening programs. The primary end point of the analysis was cervical intraepithelial neoplasia grade 2 (CIN2) or higher (as confirmed by histology) or cervical cancer found via the screening test.
One group (16,658 women) was screened via conventional cytology; the experimental group (16,706) was screened by using the ThinPrep liquid-based cytology system (Cytyc Corp., Boxborough, Mass.) and tested for HPV with the Hybrid Capture 2 assay (Digene Corp., Gaithersburg, Md.). Mean patient age was 45 years. Exclusion criteria were pregnancy, prior hysterectomy, or CIN testing within the last 5 years. (J. Natl. Cancer Inst. 2006;98;765-74).
Referral to colposcopy was triggered by a finding of atypical squamous cells of undetermined significance (ASCUS) in the conventional arm and by either findings of ASCUS or a positive (at ...