Faculty, Staff and Student Publications

Authors

    Language

    English

    Publication Date

    10-1-2008

    Journal

    Cancer Epidemiology, Biomarkers & Prevention

    DOI

    10.1158/1055-9965.EPI-08-0137

    PMID

    18843032

    PMCID

    PMC2705895

    PubMedCentral® Posted Date

    October 2009

    PubMedCentral® Full Text Version

    Post-print

    Abstract

    OBJECTIVE: We sought to evaluate the performance of the human papillomavirus high-risk DNA test in patients 30 years and older.

    MATERIALS AND METHODS: Screening (n=835) and diagnosis (n=518) groups were defined based on prior Papanicolaou smear results as part of a clinical trial for cervical cancer detection. We compared the Hybrid Capture II (HCII) test result with the worst histologic report. We used cervical intraepithelial neoplasia (CIN) 2/3 or worse as the reference of disease. We calculated sensitivities, specificities, positive and negative likelihood ratios (LR+ and LR-), receiver operating characteristic (ROC) curves, and areas under the ROC curves for the HCII test. We also considered alternative strategies, including Papanicolaou smear, a combination of Papanicolaou smear and the HCII test, a sequence of Papanicolaou smear followed by the HCII test, and a sequence of the HCII test followed by Papanicolaou smear.

    RESULTS: For the screening group, the sensitivity was 0.69 and the specificity was 0.93; the area under the ROC curve was 0.81. The LR+ and LR- were 10.24 and 0.34, respectively. For the diagnosis group, the sensitivity was 0.88 and the specificity was 0.78; the area under the ROC curve was 0.83. The LR+ and LR- were 4.06 and 0.14, respectively. Sequential testing showed little or no improvement over the combination testing.

    CONCLUSIONS: The HCII test in the screening group had a greater LR+ for the detection of CIN 2/3 or worse. HCII testing may be an additional screening tool for cervical cancer in women 30 years and older.

    Keywords

    Adult, DNA, Viral, Female, Humans, Mass Screening, Middle Aged, Papillomaviridae, Predictive Value of Tests, ROC Curve, Sensitivity and Specificity, Uterine Cervical Neoplasms, Vaginal Smears

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