The Role of Human Papillomavirus DNA Testing in Detecting High-Grade Squamous Intraepithelial Neoplasia in Women with Mild Cervical Cytologic Abnormalities

Objective: This prospective study was designed to evaluate whether human papillomavirus (HPV) DNA testing is a cost-effective tool in the management of women with atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) detected by Papanicolaou (Pap) smear. Material(s) and Method(s): Our study included a total of 513 women with ASCUS or LSIL detected by Pap smear. All then had a repeat Pap smear, HPV DNA testing, and colposcopically directed biopsies. The methods were compared with regard to sensitivity for detecting high-grade cervical intraepithelial neoplasia (CIN) and cost. Result(s): The sensitivity of HPV DNA for high-grade CIN or invasive cancer was 90.2% (37/41) for ASCUS and 95.4% (62/65) for LSIL, whereas the corresponding values for repeat Pap smears were only 71.8% (28/39) and 76.2% (48/63). In 128 women with ASCUS whose biopsy results were normal or had low-grade CIN, a positive HPV DNA test was helpful in predicting those who subsequently developed high-grade CIN. While repeat Pap smear testing was the least expensive method (NTD 11051/case of high-grade CIN detected), it was also the least sensitive. Colposcopic biopsy was less expensive than HPV DNA testing (NTD 14,034 vs. 18,709). Conclusion(s): While HPV DNA testing is sensitive in predicting concurrent and subsequent high-grade lesions, its role is limited by its cost. Colposcopic biopsy is the most cost-effective first step in evaluating women with ASCUS and LSIL. In women with high-grade CIN, therapy should be given on that basis. However, in women with ASCUS, if the biopsy results are normal or low-grade CIN, HPV DNA testing at that point is useful to predict which women will require closer follow up. In women with LSIL but with low-grade CIN on biopsy, there is no need to test for HPV since almost all will be positive, and they are suggested to perform colposcopy directly.