title: Rate of detection of high-risk HPV with two assays in women ≥ 30 years of age.
abstract: BACKGROUND
  High-risk (HR) human papillomavirus (HPV) prevalence rates, as determined by the Cervista(®) HPV HR test, in women aged ≥30 years in a routine screening population have not been studied.
  
  
  OBJECTIVE
  The primary objective of this study was to estimate HR HPV prevalence in women negative for intraepithelial lesion or malignancy (NILM) cytology using the CERVISTA HPV HR test. The study also compared HR HPV prevalence rates in women aged ≥30 years and NILM cytology using the CERVISTA HPV HR and Hybrid Capture(®) 2 (hc2) tests.
  
  
  METHODS
  A multi-center study was conducted to analyze HR HPV prevalence rates using the CERVISTA HPV HR test from residual ThinPrep(®) specimens. HR HPV positive rates were determined for hc2; percent agreement between the CERVISTA HPV HR and the hc2 tests were reported.
  
  
  RESULTS
  HR HPV prevalence rates among women with NILM cytology were not statistically different between the CERVISTA HPV HR and hc2 tests (6.92% [98/1417] versus 5.93% [84/1417], respectively; P>0.05). The overall percent agreement between the tests was 95.3% (1351/1417; 95% confidence interval [CI]: 94.1-96.3; κ=0.61, 95% CI: 0.53-0.70). There were no statistically significant differences between tests across age groups or investigational sites. For both tests, there was a statistically significant decrease in HR HPV positive results as age increases (CERVISTA HPV HR, P=0.0009; hc2, P<0.0001).
  
  
  CONCLUSIONS
  There is no statistically significant difference between HR HPV prevalence rates obtained with the CERVISTA HPV HR and hc2 tests in women aged ≥30 years with NILM cytology.
authors: Clinical Research Services, Molecular Pathology Laboratory Network, Inc., Maryville, TN 37804, USA. nquigley@mplnet.com
authors: Neil B
authors: NB
authors: Quigley
authors: Nicholas T
authors: NT
authors: Potter
authors: Mamatha
authors: M
authors: Chivukula
authors: Mirna Z
authors: MZ
authors: Knight
authors: James R
authors: JR
authors: Welch
authors: Marilyn C
authors: MC
authors: Olson
mesh_terms: D000328:Adult; D000368:Aged; D052685:Alphapapillomavirus / Q000302:isolation & purification*; D003584:Cytological Techniques; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000453:epidemiology / Q000821:virology*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000473:pathology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology