Objective: The study aimed to determine the accuracy of the colposcopy-directed punch biopsy (punch) to detect or exclude high-grade cervical intraepithelial neoplasia (CIN 2 or 3) in women with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) cytological result and minor colposcopic findings.
Materials and Methods: In a diagnostic test accuracy study, women with ASCUS or LSIL cytological result and minor colposcopic changes had a single colposcopy-targeted punch biopsy was performed immediately followed by a loop electrocautery excision procedure (LEEP) biopsy. The trial was powered to detect a level of κ for a dichotomous outcome of 0.4 (i.e., fair-to-moderate agreement), with a two-sided significance level of 5% and a power of 90%. Accuracy parameters were computed using a cutoff for positive punch biopsy result of CIN 1+ and CIN 2+ for an outcome of CIN 2+ and CIN 3+ assessed in the LEEP specimen.
Results: Sixty-eight punch biopsy/LEEP–paired samples were analyzed. Of the 8 CIN 3 lesions, 6 and 4 were detected at cutoff CIN 1+ and CIN 2+, respectively (sensitivity, 50% and 75%). The corresponding specificities were 65% (39/60) and 97% (58/60). The punch biopsies identified only 14 (67%) or 6 (20%) of the 21 CIN 2+ lesions at cutoff CIN 1+ or CIN 2+, respectively. Of the punch biopsies, 31 (45.6%) accurately detected the severity of cervical abnormality.
Conclusions: A single colposcopically directed punch biopsy appears to be insufficient to exclude underlying CIN 2 or 3.
A single colposcopy-directed punch biopsy is insufficient to exclude cervical intraepithelial neoplasia 2 or 3 in women with minor cytological lesions and minor changes on colposcopy.
Departments of 1Obstetrics and Gynaecology, and 2Pathology, University Hospital of North Staffordshire, Stoke on Trent; 3School of Computing and Mathematics, Keele University, Keele, Staffordshire, United Kingdom; and 4Unit of Cancer Epidemiology, Scientific Institute of Public Health, Brussels, Belgium
Reprint requests to: Charles W.E. Redman, MD, Department of Obstetrics and Gynaecology, University Hospital of North Staffordshire, Newcastle Rd, Stoke on Trent, Staffordshire, ST4 6QG, United Kingdom. E-mail: firstname.lastname@example.org
This study was conducted at University Hospital of North Staffordshire, Stoke on Trent, Staffordshire, United Kingdom.
This study was funded by West Midlands Cervical Screening Quality Assurance Reference Centre. The work of M. Arbyn was supported by (1) FNRS (le Fonds national de la Recherche scientifique), through TELEVIE, Brussels, Belgium (ref 7.4.628.07.F) and (2) Directorate of SANCO of the European Commission, Luxembourg, Grand-Duchy of Luxembourg), through the ECCG project (European Cooperation on development and implementation of Cancer screening and prevention Guidelines, the IARC, Lyon, France.
None of the authors have a conflict of interest.