Objective: This study aimed to estimate and compare the validity of high-risk human papillomavirus DNA (HR-HPV DNA) testing using Hybrid Capture II with and without Pap cytological examination in the detection of incident high-grade cervical intraepithelial neoplasia (CIN 2+) after treatment.
Materials and Methods: A total of 1,608 women undergoing ablative or excisional treatment were recruited to the study between May 2001 and June 2005, of whom 985 women were treated for CIN 2+. High-risk HPV DNA tests and Pap smears were performed once in every 6 months for 24 months after treatment.
Results: A total of 888 women were eligible for analysis. High-grade cervical intraepithelial neoplasia was detected in 22 women (2.5%) for the 24 months after treatment. The sensitivity for CIN 2+ detection with cytological diagnosis ranged from 43% to 100%, from 67% to 100% for HR-HPV DNA test, and from 67% to 100% for both tests combined. The specificity of cytological diagnosis ranged from 94% to 97%, from 75% to 84% for HR-HPV DNA test, and from 80% to 82% for both tests combined. The positive predictive value for cytological diagnosis ranged from 8% to 30%, from 4% to 14% for HR-HPV DNA test, and from 4% to 11% for both tests combined. The negative predictive value was 99% or greater for cytological diagnosis alone, HR-HPV DNA test alone, or for both tests combined.
Conclusions: As histologically proven CIN 2+ after treatment for this group of women was low, adding HR-HPV DNA testing to Pap smear did not increase the detection of CIN 2+ or enhance the negative predictive value of cytological diagnosis alone.