Comparison of Pap Smear Screening and Hybrid Capture II Strategies for Prediction of Cervical Intraepithelial Neoplasm

Abstract

ISEE-132 Objective: High-risk human papillomavirus (HR-HPV) is considered as a major risk for cervical intraepithelial neoplasm (CIN). Hybrid Capture II (HCII) assay detection for HR-HPV infection was considered as a screening tool for CIN. In this study, we compared HCII assay and Papanicolaou (Pap) smear on their utility in CIN screening. Material and Methods: Two hundred and sixty-nine subjects with ≥CIN1 were recruited from the annual Pap smear screening in Kaohsiung County, Taiwan. One hundred and ninety-seven of 269 subjects with both HR-HPV detection by HCII assay and biopsy confirmation were collected for subsequent estimation. Results: The sensitivity values of Pap smear were 100% not only for overall prediction but also for different grade predictions of the CIN. However, sensitivity values of HCII were 68.12% for overall prediction, with a gradual increase from 56.16%, 77.78%, 81.25%, to 100% for CIN1, CIN2, CIN3, and SCC, respectively. Higher ROC area (0.62, 95% CI: 0.34–0.83) for Pap smear than the area (0.59, 95% CI: 0.48–0.74) for HR-HPV DNA loads was found. A significant correlation between Pap smear grades (Spearman correlation coefficients r = 0.47, P < 0.0001, n = 197), as well as HR-HPV DNA load (Spearman correlation coefficients r = 0.24, P = 0.0005, n = 197), and biopsy grades were found. However, the HR-HPV DNA loads increased gradually starting from normal subjects to CIN2 and then decreased for CIN3. Conclusions: Pap smear screening was useful for the evaluation of the present cancer screening program although the HR-HPV infection detected by HCII was a notable accessory screening program for the development of cervical intraepithelial neoplasm.