title: Performance of mRNA- and DNA-based high-risk human papillomavirus assays in detection of high-grade cervical lesions.
abstract: BACKGROUND
  The aim was to assess the performance of two commercial assays for the detection of high-risk human papillomavirus (hrHPV): Aptima HPV Assay (Hologic, Inc., Marlborough, MA, USA) which detects mRNA of 14 different hrHPV types, and Hybrid Capture 2 HPV DNA test (HC2; Qiagen, Gaithersburg, MD, USA), which detects the DNA of 13 different hrHPV types. Test performance was compared in the settings of a standard colposcopy clinic, among the regular patient flow.
  
  
  METHODS
  Two separate cervical cell samples for Aptima and HC2 testing were collected from women referred to colposcopy or a cervical follow-up visit. Altogether, 481 paired samples were analyzed and all positive samples were also tested using the Aptima HPV 16 18/45 Genotype Assay. Results from the two assays were compared directly and with stratification by histology and cytology from the same sampling visit.
  
  
  RESULTS
  The overall agreement between HC2 and Aptima assays was 92.9% (Kappa coefficient of 0.855). The sensitivity and specificity of the assays in detecting CIN2+were 92.5 and 58.2% for HC2, and 94.0 and 59.3% for Aptima, respectively. No significant differences between the assays were found (p-values >0.5). Both assays detected all CIN3 (n = 30) and carcinoma (n = 2) cases.
  
  
  CONCLUSIONS
  The mRNA-based Aptima assay and the extensively studied DNA-based HC2 test performed equally well in detecting high-grade cervical lesions. Our data contribute to the growing evidence base indicating that the mRNA-based Aptima assay could be used for the triage of patients with HPV-associated cervical disease.
authors.affiliation: Department of Virology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
authors.forename: Elina
authors.initials: E
authors.lastname: Virtanen
authors.affiliation: Department of Gynecology and Obstetrics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.|Institute of Reproduction and Developmental Biology, Department of Surgery & Cancer, Imperial College London, London, UK.
authors.forename: Ilkka
authors.initials: I
authors.lastname: Kalliala
authors.affiliation: Public Health - Cancer Policy Support, Institute for Health and Consumer Protection, DG Joint Research Center, European Commission, Ispra, Italy.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Dyba
authors.affiliation: Department of Gynecology and Obstetrics, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
authors.forename: Pekka
authors.initials: P
authors.lastname: Nieminen
authors.affiliation: Department of Virology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
authors.forename: Eeva
authors.initials: E
authors.lastname: Auvinen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002277:Carcinoma / Q000175:diagnosis / Q000821:virology; D003127:Colposcopy; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D061809:Human Papillomavirus DNA Tests; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis; D012333:RNA, Messenger / Q000378:metabolism*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology
chemical_list: D012333:RNA, Messenger
keywords: 
  CIN
  ; 
  HPV
  ; Cervical intraepithelial neoplasia; diagnostics; human papillomavirus; test performance