The performance of human papillomavirus high-risk DNA testing in the screening and diagnostic settings.
OBJECTIVE
We sought to evaluate the performance of the human papillomavirus high-risk DNA test in patients 30 years and older.


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.
Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1402, USA.
Marylou
M
Cárdenas-Turanzas
Graciela M
GM
Nogueras-Gonzalez
Michael E
ME
Scheurer
Karen
K
Adler-Storthz
J L
JL
Benedet
J Robert
JR
Beck
Michele
M
Follen
Scott B
SB
Cantor
D000328:Adult; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D012372:ROC Curve; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears
D004279:DNA, Viral