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.
Cárdenas-Turanzas
Marylou
M
Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1402, USA.
Nogueras-Gonzalez
Graciela M
GM
Scheurer
Michael E
ME
Adler-Storthz
Karen
K
Benedet
J L
JL
Beck
J Robert
JR
Follen
Michele
M
Cantor
Scott B
SB
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