Comparison of two signal-amplification DNA tests for high-risk HPV as an aid to colposcopy
Pretorius, R.G.; Peterson, P.; Novak, S.; Azizi, F.; Sadeghi, M.; Lorincz, A.T.
Journal of Reproductive Medicine 47(4): 290-296
2002
ISSN/ISBN: 0024-7758 PMID: 12012880 Document Number: 542300
OBJECTIVE: To compare Hybrid Capture(R) Tube (HCT) and the second-generation Hybrid Capture II(R) (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 chi2 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 gtoreqCIN 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 gtoreqCIN 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 gtoreqCIN 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.