title: The clinical performance of APTIMA human papillomavirus and Hybrid Capture 2 assays in the triage of lesser abnormal cervical cytologies.
abstract: OBJECTIVE
  This study was performed to evaluate the clinical performance of APTIMA human papillomavirus (AHPV) assay and Hybrid Capture 2 (HC2) assay in screening for cervical disease, especially in women with atypical squamous cell of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL).
  
  
  METHODS
  A total of 411 women diagnosed with ASC-US or LSIL were referred and further triaged by HC2 test. Prior to colposcopy, liquid-based cytology specimens were collected for the AHPV assay. Sensitivity and specificity were established based on the histological findings of cervical intraepithelial neoplasia (CIN).
  
  
  RESULTS
  In all 411 subjects, the positive detection rate of AHPV assay was 70.8% (95% confidence interval [CI], 66.4 to 75.2), which was significantly lower than the positive detection rate of 94.9% obtained using HC2 test (95% CI, 92.3 to 96.8). Only one CIN 3-positive case was detected among the 120 AHPV-negative women, which was then confirmed by Pap smear test to be LSIL. The sensitivities of AHPV and HC2 for CIN 3 were similar (94.1% and 100%, respectively). However, AHPV showed a significantly higher specificity than HC2 test (30.2% and 5.3%, respectively; p<0.001).
  
  
  CONCLUSIONS
  AHPV assay is effective in identifying CIN 3-positive cases because of its high specificity and lower false-negative rate. The use of AHPV for the triage of ASC-US and LSIL might help to reduce the referral rate of colposcopy during cervical cancer screening.
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
authors.forename: Yanli
authors.initials: Y
authors.lastname: Guo
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
authors.forename: Ke
authors.initials: K
authors.lastname: You
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China. gengli57@163.com.
authors.forename: Li
authors.initials: L
authors.lastname: Geng
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qiao
mesh_terms: D000328:Adult; D000368:Aged; D002681:China / Q000453:epidemiology; D003127:Colposcopy / Q000379:methods; D055088:Early Detection of Cancer / Q000379:methods; D005188:False Negative Reactions; D005260:Female; D061809:Human Papillomavirus DNA Tests / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D015995:Prevalence; D012680:Sensitivity and Specificity; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology
keywords: Early detection of cancer; Human Papillomavirus; Triage; Uterine cervical dysplasia; Uterine cervical neoplasms