title: Analytical performance of cervista HPV 16/18 in SurePath pap specimens.
abstract: BACKGROUND
  To evaluate the performance of Cervista HPV 16/18 in SurePath specimens, we compared the analytical sensitivity of Cervista HPV 16/18 with that of a previously validated PCR-based, commercially available HPV genotyping assay, EasyChip HPV Blot, in residual specimens collected after routine Pap tests at our cancer center.
  
  
  METHODS
  We retrospectively selected 79 consecutive Cervista HPV HR (high risk)-positive SurePath residual Pap specimens. The cytology results for these specimens comprised 42 negative, 22 ASC-US/ASC-H, 10 low-grade squamous intraepithelial lesions, and 5 high-grade squamous intraepithelial lesions. HPV 16/18 genotypes of the 79 specimens were analyzed by Cervista HPV 16/18 assay and EasyChip genotyping assay and compared with the patient's follow-up results.
  
  
  RESULTS
  Of the 79 cases, 33 (42%) were positive for HPV16/18 by Cervista HPV 16/18 and 37 (47%) were positive by EasyChip. The overall agreement between the 2 assays, at 85% (67/79), was good (kappa = 0.698, 95% CI: 0.541-0.855). In the 65 patients with follow-up results, the sensitivity for predicting cervical intraepithelial neoplasia grade 2 or higher (CIN2+) was 77% for Cervista HPV 16/18 assay and 69% for EasyChip. The predictive values for CIN2+ in cases stratified by Pap results were highly consistent between the Cervista HPV16/18 and EasyChip assays; there was one false negative HPV16 result, in a specimen identified as NILM by EasyChip.
  
  
  CONCLUSIONS
  Our findings support use of the Cervista HPV 16/18 assay for HPV16/18 genotyping in SurePath Pap specimens. However, further studies of larger cohorts with clinical follow-up data are required to verify the efficacy of Cervista HPV16/18 assay in SurePath Pap specimens.
authors.affiliation: Department of Pathology, the University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Ming
authors.initials: M
authors.lastname: Guo
authors.forename: Abha
authors.initials: A
authors.lastname: Khanna
authors.forename: Jie
authors.initials: J
authors.lastname: Feng
authors.forename: Shobha
authors.initials: S
authors.lastname: Patel
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Yun
authors.initials: Y
authors.lastname: Gong
authors.forename: Lei
authors.initials: L
authors.lastname: Huo
authors.forename: Gregg
authors.initials: G
authors.lastname: Staerkel
mesh_terms: D000328:Adult; D000368:Aged; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology*; D015331:Cohort Studies; D005260:Female; D005838:Genotype; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification*; D052161:Human papillomavirus 18 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test / Q000379:methods; D030361:Papillomavirus Infections / Q000473:pathology* / Q000821:virology*; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000821:virology*
keywords: EasyChip HPV blot; HPV; cervista HPV16/18; genotyping