The Performance of Human Papillomavirus High-Risk DNA Testing in the Screening and Diagnostic Settings
- Marylou Cárdenas-Turanzas1,
- Graciela M. Nogueras-Gonzalez1,
- Michael E. Scheurer3,
- Karen Adler-Storthz4,
- J.L. Benedet5,
- J. Robert Beck6,
- Michele Follen2 and
- Scott B. Cantor1
- Departments of 1Biostatistics and 2Gynecologic Oncology, The University of Texas M. D. Anderson Cancer Center; 3Department of Pediatrics and Dan L. Duncan Cancer Center, Baylor College of Medicine; and 4Department of Diagnostic Sciences, The University of Texas Dental Branch at Houston, Houston, Texas; 5Division of Gynecologic Oncology, Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, Canada; and 6Division of Population Science, Fox Chase Cancer Center, Philadelphia, Pennsylvania
- Requests for reprints:
Scott B. Cantor, Department of Biostatistics-Unit 1411, Section of Health Services Research, The University of Texas M. D. Anderson Cancer Center, P.O. Box 301402, Houston, TX 77230-1402. Phone: 713-745-5984; Fax: 713-563-4243. E-mail: sbcantor{at}mdanderson.org
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. (Cancer Epidemiol Biomarkers Prev 2008;17(10):2865–71)
Footnotes
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Grant support: Grant number CA82710 from the National Cancer Institute. The funding agreement ensured the authors' independence in designing the study, interpreting the data, and writing and publishing the report.
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Note: This study was conducted by The University of Texas M. D. Anderson Cancer Center Departments of Biostatistics and Gynecologic Oncology, the University of British Columbia Department of Obstetrics and Gynaecology, and the Fox Chase Cancer Center Division of Population Science. This study was conducted at sites in Houston, Texas and Vancouver, British Columbia, Canada.
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- Accepted July 31, 2008.
- Received February 12, 2008.
- Revision received July 16, 2008.
