title: Clinical performance of the APTIMA HPV Assay for the detection of high-risk HPV and high-grade cervical lesions.
abstract: BACKGROUND
  Human papillomavirus (HPV) DNA testing is widely used in conjunction with Papanicolaou (Pap) testing in cervical cancer screening programs to improve the detection of high-grade lesions. While HPV DNA test sensitivity is good, an improvement in specificity is desired. Detection of HPV mRNA may improve specificity. The APTIMA HPV Assay detects the mRNA of 14 high-risk HPV types in liquid-based cytology specimens.
  
  
  OBJECTIVE
  To evaluate APTIMA HPV Assay performance for detection of high-risk HPV and high-grade cervical intraepithelial neoplasia (CIN) compared to Qiagen's Hybrid Capture 2 HPV DNA (HC2) test.
  
  
  METHODS
  Liquid Pap specimens were collected from 800 women referred to colposcopy and tested with the APTIMA HPV Assay and the HC2 test. Complete results were available for 753 subjects. A subset of samples (n = 393) were typed using Roche's Linear Array HPV Genotyping Test.
  
  
  RESULTS
  Sensitivity and specificity for detection of high-risk HPV were >92% and 99% for the APTIMA HPV Assay and 93% and 82% for the HC2 test. Clinical sensitivity and specificity were 91% and >55% for detection of CIN 2+, and 98% and 53% for detection of CIN 3+ for the APTIMA HPV Assay; values for the HC2 test were 95% and 47% for CIN 2+, and 99% and 44% for CIN 3+.
  
  
  CONCLUSIONS
  The APTIMA HPV Assay is sensitive and very specific for detection of high-risk HPV. The APTIMA HPV Assay had similar clinical sensitivity for disease detection but higher clinical specificity than the HC2 test, which may improve patient management and reduce the cost of care.
authors: Gen-Probe Incorporated, San Diego, CA 92121, USA. janeld@gen-probe.com
authors: Janel
authors: J
authors: Dockter
authors: Astrid
authors: A
authors: Schroder
authors: Craig
authors: C
authors: Hill
authors: Leah
authors: L
authors: Guzenski
authors: Joseph
authors: J
authors: Monsonego
authors: Cristina
authors: C
authors: Giachetti
mesh_terms: D002584:Cervix Uteri / Q000821:virology*; D005260:Female; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D012333:RNA, Messenger / Q000032:analysis* / Q000235:genetics; D012367:RNA, Viral / Q000032:analysis* / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
chemical_list: D012333:RNA, Messenger; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic