title: Comparison of two signal-amplification DNA tests for high-risk HPV as an aid to colposcopy.
abstract: 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.
  
  
  METHODS
  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 chi 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 > or = 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 > or = CIN 2 was lower than that for HCT (63% [60.5-66.2%] vs. 73% [69.5-74.8%], P < .005).
authors.affiliation: Departments of Obstetrics and Gynecology and of Pathology, Southern California Permanente Medical Group, 9961 Sierra Boulevard, Fontana, CA 92335, USA. robert.g.pretorius@kp.org
authors.forename: Robert G
authors.initials: RG
authors.lastname: Pretorius
authors.forename: Pat
authors.initials: P
authors.lastname: Peterson
authors.forename: Susan
authors.initials: S
authors.lastname: Novak
authors.forename: Faramarz
authors.initials: F
authors.lastname: Azizi
authors.forename: Masood
authors.initials: M
authors.lastname: Sadeghi
authors.forename: Attila T
authors.initials: AT
authors.lastname: Lorincz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D003127:Colposcopy; D005260:Female; D006801:Humans; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000150:complications / Q000235:genetics* / Q000473:pathology*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D014412:Tumor Virus Infections / Q000150:complications / Q000235:genetics* / Q000473:pathology*; D002583:Uterine Cervical Neoplasms / Q000209:etiology / Q000235:genetics / Q000473:pathology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000209:etiology / Q000235:genetics / Q000473:pathology