title: Efficacy of Abbott RealTime High Risk HPV test in evaluation of atypical squamous cells of undetermined significance from an Asian screening population.
abstract: BACKGROUND
  Abbott RealTime High Risk HPV test is a new qualitative real-time PCR assay for the detection of 14 high risk HPV (HR-HPV) types and specific identification of HPV16 and HPV18. For each new HPV DNA test, it is important to validate its clinical performance using established tests as benchmarks. Hybrid Capture 2 (HC2) is the first USA FDA-approved HR-HPV DNA test.
  
  
  OBJECTIVE
  To compare the performance of Abbott RealTime High Risk HPV test with that of Hybrid Capture 2 in detecting cytology samples with varying prognosis.
  
  
  METHODS
  250 liquid-based cervical cytology samples diagnosed of Atypical Squamous cells of Undetermined Significance (ASC-US) collected from an Asian Screening Population were independently tested with both Abbott RealTime High Risk HPV test and HC2. Their utility in predicting disease progression was evaluated in 82 of the samples for which follow up cytology or colposcropic histology data was available.
  
  
  RESULTS
  Good to excellent agreement between the two tests was demonstrated (Kappa=0.800, 95% CI: 0.726-0.874). The sensitivity, specificity, positive (PPV) and negative predictive values (NPV) of the two tests in detecting cases with underlying HSIL/CIN2+ were evaluated (Abbott: 100%, 20.83%, 14.93% and 100% respectively; HC2: 100%, 12.50%, 13.70% and 100% respectively). HPV16/18 genotyping provided by the Abbott test enhanced specific identification of cases with LSIL/CIN1+ (specificity 91.30%, PPV 84.62%) and HSIL/CIN2+ (specificity 86.11%, PPV 23.08%) at follow-up.
  
  
  CONCLUSIONS
  The Abbott test performed similarly to HC2 and is unlikely to be affected by ethnicity. Abbott combined HPV detection and HPV 16/18 genotyping is found to provide enhanced sensitivity and specificity for triage of ASC-US.
authors.affiliation: Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Pokfulam Road, Hong Kong Special Administrative Region, Hong Kong, China.
authors.forename: Oscar Gee-Wan
authors.initials: OG
authors.lastname: Wong
authors.forename: C K
authors.initials: CK
authors.lastname: Lo
authors.forename: Elaine
authors.initials: E
authors.lastname: Szeto
authors.forename: Annie Nga-Yin
authors.initials: AN
authors.lastname: Cheung
mesh_terms: D000293:Adolescent; D000328:Adult; D044466:Asian People; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D030361:Papillomavirus Infections / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*; D055815:Young Adult