title: Comparison of Abbott RealTime High Risk HPV and Hybrid Capture 2 for the detection of high-risk HPV DNA in a referral population setting.
abstract: BACKGROUND
  The Abbott RealTime High Risk HPV assay (ART) is an automated multiplex real-time PCR test for detection of DNA from 14 high risk (HR) HPV types in cervical specimens and simultaneous distinction of HPV16 and HPV18 from other HR-HPV.
  
  
  OBJECTIVE
  To evaluate the performance of the ART assay in specimens referred for HPV testing to our laboratory (referral population) by comparison with historical data from HC2 and INNO-LiPA as well as histological status, if available.
  
  
  METHODS
  412 cervical specimens were collected from women between 18 and 70 years of age: 301 previously tested by HC2 without clinical data and 111 previously tested by HC2 and INNO-LiPA with histological diagnosis of CIN3+.
  
  
  RESULTS
  Our study demonstrated good overall agreement between ART, HC2 and INNO-LiPA. In the group of the CIN3+ specimens HR-HPV was detected by ART in 93.07% (95% CI: 88.12-98.02), while HR-HPV detection rates with HC2 and INNO-LiPA were 91.09% (95% CI: 85.53-96.65) and 95.05% (95% CI: 90.82-99.28), respectively. The typing capability of ART for HPV16, HPV18 and a pool of twelve other HR-HPV types was investigated by comparison with INNO-LiPA demonstrating high overall assay concordance (89.81%; k 0.87).
  
  
  CONCLUSIONS
  The Abbott RealTime assay showed similar clinical performance for detection of CIN3+ compared with HC2. The high level of automation and ability to identify HPV16, HPV18 and other HR-HPV make this assay a very attractive option for HR-HPV testing, potentially improving patient management by risk stratification of cytological abnormal populations.
authors: Department of Haematology, Oncology an Laboratory Medicine, Section of Microbiology, S. Orsola-Malpighi Hospital, University of Bologna, via Massarenti 9, 40138 Bologna, Italy. simona.venturoli@unibo.it
authors: Simona
authors: S
authors: Venturoli
authors: Elisa
authors: E
authors: Leo
authors: Martina
authors: M
authors: Nocera
authors: Daniela
authors: D
authors: Barbieri
authors: Monica
authors: M
authors: Cricca
authors: Silvano
authors: S
authors: Costa
authors: Donatella
authors: D
authors: Santini
authors: Marialuisa
authors: M
authors: Zerbini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000032:analysis* / Q000235:genetics; D005260:Female; D052162:Human papillomavirus 16 / Q000145:classification / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000145:classification / Q000235:genetics*; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012017:Referral and Consultation / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012306:Risk; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000821:virology*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000821:virology*
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic