High-Risk Human Papillomavirus DNA Test Results Are Useful for Disease Risk Stratification in Women With Unsatisfactory Liquid-Based Cytology Pap Test Results

This study assesses whether high-risk human papillomavirus (HPV) DNA test results from residual vial fluid of unsatisfactory liquid-based cytology(LBC) samples might provide useful information on disease risk.Patients with unsatisfactory imaged ThinPrep Pap test results and available Hybrid Capture 2 high-risk HPV results were identified at an academic women's hospital laboratory between July 1, 2005, and July 31, 2007. Follow-up repeat cytology results, HPV results, and available biopsy results were analyzed.Three hundred four patients with unsatisfactory cytology results and HPV test results were studied. Eleven (3.6%) of 304 tested positive for HPV DNA, and 293 tested HPV negative. Five (45%) of 11 HPV-positive patients had detectible low-grade squamous intraepithelial/cervical intraepithelial neoplasia 1 during a mean follow-up period of almost 6 months. Among 293 women with negative HPV results, only 1 case of cervical intraepithelial neoplasia 1 was identified during roughly the same follow-up period.A positive high-risk HPV result associated with an unsatisfactory ThinPrep Pap test result identified patients at risk for diagnosis of an undetected squamous intraepithelial/cervical intraepithelial neoplasia. Negative high-risk HPV results associated with an unsatisfactory LBC had high negative predictive value in this limited study. The overall low detection rate for significant disease on follow-up of all patients with unsatisfactory imaged LBC is similar to findings reported in another LBC study but differs from studies reporting increased risk for undetected disease in women screened with unsatisfactory conventional Pap smears.