Comparison of two signal-amplification DNA tests for high-risk HPV as an aid to colposcopy.

OBJECTIVE: To compare Hybrid Capture® Tube (HCT) and the second-generation Hybrid Capture II® (HC II) test for detection of high-risk human papillomavirus (HPV) DNA at the time of colposcopy. STUDY DESIGN: Colposcopy and HPV testing were performed by HCT and HC II on 1,309 women for evaluation of abnormal Pap smears. Differences in the proportions were tested with X 2 and 95% CI calculations. RESULTS: When compared to HCT, HC II was more often positive in women with any abnormal Pap smear (44% [95% CI 41-46%] vs. 34% [31-37%], P<.005) and in the subset of women with atypical squamous cells of undetermined significance Pap smears (32% [29-35%] vs. 24% [22-27%], P<.005). HC II was more sensitive in detecting cervical intraepithelial neoplasia (CIN) 2 or worse (93% [88-97%] vs. 78% [70-84%], P<.005) and had a lower rate of undetected ≥ CIN 2 in HPV test-negative subjects (1.5% [0.7-2.7%]) vs. 4.3% [3.0-5.9%], P<.005). HC II was also more often positive in women with negative colposcopic evaluations (29% [25.7-32.4%] vs. 20% [17.6-23.5%], P<.005). The specificity of HC II in detection of ≥CIN 2 was lower than that for HCT (63% [60.5-66.2%] vs. 73% [69.5-74.8%], P<.005). CONCLUSION: HC II was more sensitive than HCT in diagnosing high-risk HPV and in predicting which patients had ≥CIN 2 and can be used to determine which women with ASCUS smears should be referred for colposcopy and can be used at the time of colposcopy to detect high-risk HPV.