title: Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection.
abstract: BACKGROUND
  Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes.
  
  
  OBJECTIVE
  To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+).
  
  
  METHODS
  The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA.
  
  
  RESULTS
  HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k=0.85) and 96% (k=0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in <CIN2 patients (p<.0001); 60% in CIN3+ vs. 47% in <CIN3 patients (p not significant).
  
  
  CONCLUSIONS
  The clinical performance of the Abbott RT HR HPV assay is good and closely correlated with the two other assays. The automation and ability to identify type 16 and 18 make this a very attractive option for HPV testing in laboratories and potentially provides improved patient management.
authors.affiliation: Hôpital Ambroise Paré, Marseille, France. philippe.halfon@alphabio.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Halfon
authors.forename: Dominique
authors.initials: D
authors.lastname: Benmoura
authors.forename: Aubert
authors.initials: A
authors.lastname: Agostini
authors.forename: Hacene
authors.initials: H
authors.lastname: Khiri
authors.forename: Guillaume
authors.initials: G
authors.lastname: Penaranda
authors.forename: Agnes
authors.initials: A
authors.lastname: Martineau
authors.forename: Bernard
authors.initials: B
authors.lastname: Blanc
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001331:Automation; D005260:Female; D005453:Fluorescence; D005602:France; D006801:Humans; D008875:Middle Aged; D015345:Oligonucleotide Probes / Q000235:genetics; D027383:Papillomaviridae / Q000145:classification* / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D015345:Oligonucleotide Probes; D011933:Reagent Kits, Diagnostic