Diagnostic accuracy of guided cervical biopsies: a prospective multicenter study comparing the histopathology of simultaneous biopsy and cone specimen.

Abstract

We sought to determine the validity of colposcopically directed cervical biopsies as a diagnostic test to define the degree of cervical intraepithelial neoplasia (CIN). In a prospective multicenter trial, patients undergoing excisional procedures of the transformation zone additionally had colposcopy and up to 3 guided cervical biopsies in a single procedure. Cervical biopsies were regarded as a diagnostic test to detect high-grade lesions (CIN 2,3), with the cone specimen as reference standard. In all, 488 biopsies were performed in 244 cases, with 2 biopsies done in 192 cases. Cervical biopsies underestimated the severity of lesions in 46.7% of cases. Sensitivity, specificity, and positive and negative predictive values were 66.2% (95% confidence interval [CI], 59.4-72.3), 95.0% (95% CI, 83.5-98.6), 98.5% (95% CI, 94.8-99.6), and 35.5% (95% CI, 27.1-44.9), respectively. Our data suggest that cytologically suspected high-grade lesions (CIN 2,3) can be confirmed by biopsy in many cases, but they cannot be excluded.